Nightguard Vital Bleaching:

A Long-Term Study on Efficacy7Shade Retention,

Side Effects, and Patients’ Perceptions
R A L P H H. L E O N A R D J R . , DDS, M P H *
C A R O L Y N B E N T L E Y , DDS‘
JAMES C . EAGLE, DDSt
GLENN E. GARLAND, DDSt
M A R Y C. K N I G H T , D D S I
C E I B PHILLIPS, PI-ID, M P H #

ABSTRACT
Background: The scientific literature is lacking in long-term clinical data on the duration of efficacy
and post-treatment side effects of nightguard vital bleaching.
Purpose: This longitudinal clinical study was undertaken (1)to determine the clinical efficacy and
duration of efficacy at 3 , 6 , and 47 months post treatment of a peroxide-containing whitening solu-
tion; ( 2 )to evaluate safety issues with respect to using a peroxide whitening solution; and ( 3 )to
determine patients’ perceptions of the whitening technique.
Materials and Methods: This project was part of a nightguard vital bleaching study involving human
participants. The study teeth for efficacy and duration of efficacy when using a 10% carbamide per-
oxide solution were the four maxillary central and lateral incisors, with the tooth shade being taken
from the middle third of the tooth. Safety issues evaluated were the changes in gingival index (GI),
plaque index (PI), nonmarginal gingival index (NMGI), nongingival oral mucosal index (NGOMI),
and tooth vitality (TV). Radiographic changes of the study teeth and the patients’ perceptions of tooth
sensitivity (TS) or gingival irritation (Girr) during treatment and post treatment were also evaluated.
Results: The active 10% carbamide peroxide whitening solution used in this study was effective in light-
ening teeth (98%), and this effect was sustained at a mean of 47 months post treatment in 82% of the
participants. When evaluating safety issues, 66% of the participants using the active solution reported
TS o r Girr. No one reported TS or Girr or any other adverse effects at the end of the study.
Conclusions: The results of this study concur with those of previously reported studies that night-
guard vital bleaching using a 10% carbamide peroxide whitening solution according to the manufac-
turer’s instructions is efficacious and safe, with minimal side effects. In addition, long-term shade
retention was reported by 82% of the participants at the end of the study, with n o adverse side effects.
CLINICAL SIGNIFICANCE
Results of this study should reassure dentists that nightguard vital bleaching is a safe, effective, and
predictable method to lighten teeth. The whitening effect lasted up to 47 months in 82% of the
patients, with no adverse side effects reported at the end of the study.
u
Esthet Restor Dent 13:357-369, 2001)

‘Associate Professor, Department of Diagnostic Sciences and General Dentistry, University of North Carolina
School of Dentistry, Chapel Hill, North Carolina
fProfessor, Department of Diagnostic Sciences and General Dentistry, University of North Carolina School of
Dentistry, Chapel Hill, North Carolina
#Assistant Professor, Department of Diagnostic Sciences and General Dentistry, University of North Carolina
School of Dentistry, Chapel Hill, North Carolina
$Private Practice, Raleigh, North Carolina
#Research Professor, Department of Orthodontics, University of North Carolina School of Dentistry, Chapel Hill,
North Carolina

V O L U M E 13, N U M B E R 6 , 2001 357

 N I G H T G U A R D V I T A L B L E A C H I N G : A L O N G - T E R M S T U D Y ON E F F I C A C Y .
SHADE R E T E N T I O N . S I D E E F F E C T S . A N D P A T I E N T S ' P E R C E P T I O N S
N- ightguard viral bleaching
i SG\33i or dsntist-super-
\-ised-Farienr-applied bleachins has
gained acceprance among denrists
as an eft'eitive and simple method
of lightening extrinsically stsined o r
discolored teeth.'-' Since irs intro-
ducrion by Ha!-nood and Heymann
in 1989, the original technique has
undergone many modifications.
improvements, and variations.""
Numerous SG1.B efficacy studies
have been reported in the denral lit-
erature. I .4:.-.15-2; Similarly, studies
concerning safen issues have also
been reported.'&'" Some of the
safe? issues evaluated have docu-
mented the effect of 10'0 carbamide
peroxide tCP) on gingival and
mucosal soft tissues, pulpal tissue.
plaque index (PILand restorative
materials. From these studies, it can
be concluded that SG\'B using a
10"; CP solution is safe and effective
in \vhitening estrinsically stained
teeth with respect to these issues.
Only three studies report long-term
data of 2 !-ears or .Ad&-
tionall!; none of the studies com-
prehensi\-eiy reports radiographic
changes of the teeth. tooth vitality
changes. o r patients' perceptions of
the whitening procedure.
The purposes of this longitudinal
clinical study were ( 1) to determine
the clinical efficacy and duration of
efficacy a t 3. 6, and 47 months post
treatment of a peroxide-containing
whitening solution; ( 2 )to evaluate
saiery issues with respect to using a
peroxide \vhitening solution; and
355 JOURN;\L O F ESTHETIC A S D R E S T O R A T I V E D E N T I S T R Y
( 3I to determine patients' percep-
tions of the \\ hitening technique.
I 11E T H 0 I) 5
11 .AT t R 1 .A L S .A \-D
This project was part of a double-
blind nightguard vital bleaching
stud!- involving human subjects
interested in having their teeth
n-hitened. XI1 participants n.ere
enrolled in the University of North
Carolina (UNC) School of Den-
tistry's Clinical Research Unit.
Participants \yere randomly assigned
to either an active o r a placebo
(control)group. The active group
used a 1006 CP Lvhitening solution
in a sy-inge system (NiteWhite
Classic', Discus Dental Inc., Culver
City, California). The control group
used the same type of delivery sys-
tem and product vehicle (glycerin)
as the active group, but without
the ivhitening agent. =\ stratified
blocked randomization approach
\vas used to assign participants to
their treatment agent. The stratifi-
cation factors were age, gender,
a n d oral health status. Each partic-
ipant received an oral examination
and oral prophylasis at least
2 rveeks prior to beginning the
treatment phase of the study and
agreed not to have professional
oral prophylaxis or use antimicro-
bial mouthwash during the study.
Other inclusion criteria for the
study included following a stan-
dard oral hygiene regimen: refrain-
ing from smoking a n d the con-
sumption of red wine, coffee, and
tea throughout the study; tooth
shade of Vita@A3 or darker; and
absence of periodontal disease.
A maxillary polyvinyl siloxane
(Estrude"', Kerr Corp., Roniulus,
A'lichigan) impression was taken o f
each participant a n d sent to the
manufacturer (Discus Dental) for
ia brication of the whitening tray.
The tray was fabricated using a
5.0'' X 5.0'' X 0.040" plastic Sheet
having a 0.5-mni facial reservoir on
the masillary teeth from the right
to the left canine. The tray was of a
scalloped gingival design to avoid
soft-tissue contact. Only the niaxil-
lary arch was evaluatcd for poten-
tial lightening. The study teeth for
efficacy and duration of efficacy
were the four maxillary central and
lateral incisors, with the tooth
shade being taken from the middle
third of the tooth. Study teeth were
Vita shade A 3 o r darker (Vita
Lumin@,Bad Sackingen, Gel-many).
Figure 1 ranks the Vita shade tabs
when arranged i n order of value per
manufacturer's instructions (I31 = I ,
A1=2, ... C 4 = 16). A smaller num-
ber means the tooth is lighter. Intra-
oral color slides were taken to
record tooth shade with the appro-
priate Vita shade tab for docunien-
tation of present shade and for
future comparison i f a shade
change occurred. Shade determina-
tions were performed in the same
clinic with blinds lowered, color-
corrected lights, and a blue patient
napkin on the patient's chest. All
lipstick, chapstick, etc., was
removed from the patient's lips
before shade determinations were
made. The shade recorded was the
one agreed upon by two examiners.
If the two examiners could not agree
 B1 A1 B2 D2 A2 C1 C2 D4 A3 D3 B3 A3.5 B4 C3 A 4 C4
Figure 1. Vita shade tab8s arranged in order of value according to the manufacturer's
instructions.

on a shade, a third examiner was (TV). In addition, radiographic and described by Curtis and col-
consulted and a consensus reached changes of the study teeth and the leagues (see Table l).24Examiners
among all examiners. This study patients' perceptions of tooth sensi- completed calibration sessions on
was designed such that the same tivity (TS) or gingival irritation GI, PI, NMGI, and NGOMI prior
examiners saw the same patients as (Girr) during treatment and post to beginning the study.
much as possible. Examiners com- treatment were evaluated.
pleted calibration sessions on shade Tooth vitality of four teeth, maxil-
determination prior to beginning the To assess the gingival conditions lary right lateral to left lateral
study. In the absence of agreement of each participant, the Loe-Silness incisor, on each of the subjects
regarding shade during the calibra- GI was employed in the maxillary was tested using Histofreeze"
tion session, differences were dis- arch from the right second premo- 2000 (Fisherbrand@,Fisher
cussed and a consensus reached. To lar to the left second premolar Scientific, Pittsburgh, Pennsylvania).
be considered efficacious, the treat- (Table 1).31-33Each quadrant was A response to the Histofreeze 2000
ment solution must be capable of isolated with cotton rolls, air within 10 seconds was recorded
producing at least a two-shade dried, and visibly and tactically as a positive response. If there was
change on a value-oriented scale. inspected using a mouth mirror no response to Histofreeze 2000
This change must be maintained in at and probe. Four gingival areas within 10 seconds, a negative
least 50% of the participants receiv- (distal, facial, mesial, lingual) were response was recorded. There was
ing the active solution at 6 months examined systematically for each no attempt on behalf of the exam-
post treatment. This is consistent tooth. Plaque accumulations were iners to quantify the response.
with the American Dental Associa- scored using the PI method of Loe Pretreatment and 6-month post-
tion (ADA) guidelines for peroxide- and Silness (see Table 1).32,33The treatment radiographs were taken
containing whitening p r o d ~ c t s . ~ ' PI was carried out in a manner to evaluate radiographic changes
similar to that used for the GI. on the study teeth. A log form
Safety issues evaluated were the completed by the participant
changes in gingival index (GI), PI, To evaluate soft-tissue changes during treatment and a question-
nonmarginal gingival index occurring in the oral cavity (ulcers, naire post treatment evaluated
(NMGI), nongingival oral mucosal abrasion, etc.), the NMGI and the patients' perceptions of TS
index (NGOMI), and tooth vitality NGOMI were used, as developed or Girr.

V O L U M E 13, N U M B E R 6 , 2 0 0 1 359
 N I G H T G U A R D V I T A L B L E A C H I N G : A L O N G - T E R M S T U D Y ON E F F I C A C Y .
SHADE R E T E N T I O N . S I D E E F F E C T S . A N D P A T I E N T S ’ P E R C E P T I O N S

At the insertion appointment, a
minimum of 2 weeks after the oral
prophylaxis, a pretreatment radio-
graph was taken and the whitening
tray was delivered and adjusted
intraorally, according to the guide-
lines prescribed by the manufac-
turer. This began the treatment
phase of the study, which continued
for a total of 14 days. Baseline
tooth shade for the four maxillary
incisors was determined by Vita
shade tabs and recorded in the par-
ticipant’s chart. Each participant’s
baseline maxillary GI and PI was
determined at this appointment as
well as NMGI and NGOMI.
Tooth vitality of the four maxillary
incisors was also determined. Infor-
mation about the whitening process
and written instructions were given
to each parricipant as well as a
daily log form to record enamel
shade changes, TS, Girr, and other
comments or concerns.
Participants were seen after 7
and 14 days of total treatment to
evaluate tooth shade change, GI,
PI, NMGI, NGOMI, TV,TS, Girr,
and concerns of the participant.
Treatment was discontinued at
the end of 14 days, at which time
the log forms were collected.
Participants were seen at 3 and
6 months post treatment to evalu-
ate tooth shade changes, GI, PI,
NMGI, NGOMI, TV,TS, and
Girr and to complete a question-
naire on patient perception of the
NGVB procedure (Table 2). At the
6-month post-treatment appoint-
ment, a post-treatment radiograph
was taken.
At the 6-month post-treatment
appointment, participants in the
control group were given the option
of treating their teeth with the
active 10% solution for 2 weeks for
6 to 8 hours per night. Seventeen
of the 24 participants chose to
participate in this portion of the
study. At 47 months post treatment
(range, 36-55 mo), participants
who had treated their teeth with the
active solution (original active par-
ticipants and the control crossover
participants) were asked to return
to the clinic for evaluation of tooth
shade change, GI, PI, NMGI,
NGOMI, TV,TS, Girr, and con-
cerns of the participant. Data
gathered for the two groups at this
appointment were combined into
one group, the combined group.
Hereafter, data are presented as

TABLE 1. RANKING S C A L E S OF CLINICAL M E A S U R E M E N T S .

Nonmarginal Gingival Index and
kltins Plaque Index Gingival Index Nongingival Oral Mucosal index
0 So plaque in the gingival area Normal gingiva No evidence of abnormality
1 A film of plaque adhering to the Mild inflammation Erythema present
free gingival margin and adjacent Slight change in color No evidence of ulceration
area of the tooth, recognizable Slight edema
only by running a probe across No bleeding on probing
the tooth surface
-7 Moderate accumulation of plaque Moderate inflammation Mild ulceration
within the gingival margin or on Redness Minimal loss of epithelial integrity
the adjacent tooth surface that Edema
can be seen by the naked eye Glazing
Bleeding on probing
3 Abundance of plaque within the Severe inflammation Frank ulceration
gingival pocket or on the gingival Marked redness Sigdicant loss of epithelial
margin and adjacent tooth surface Edema integrity or tissue sloughing
Glazing
Ulceration
Tendency to bleed spontaneously
Repriutedby permission of ADA Publishing CO., a Division of ADA BnsinesS Enterprises, Inc., from Curtis JW, Dickinson GL, dome^ MC,et aL
Assessing the effects of 10 percent carbamidc peroxide on oral soft tissues.. J Am Dent Assoc 1996; 127:1220.

360 J O U R N A L OF E S T H E T I C A N D R E S T O R A T I V E D E N T I S T R Y
 TABLE 2. PATIENTS‘ PERCEPTIONS OF SHADE STABILITY AND SIDE EFFECTS 3, 6, AND 47 M O N T H S AFTER NIGHTGUARD
VITAL BLEACHING TREATMENT.

Active Control Combined

Question 3 Month 1%) 6 Month 1%) 3 Month 1%) 6 Month 1%) 47 Month* 1%)
__ (n = 23) In = 24) (n 22) (n = 24) (n = 31)
Since treating your teeth, what is the current status?
Circle the one that most applies, A-E.
A. There has been no obvious change in color. 59 31 88 91 18
B. There has been a slight darkening, but it is not 26 50 6 9 53
noticeable by other people.
C. There has been a slight darkening that is 11 13 6 0 4
probably noticeable by other people.
D. There has been a moderate darkening but not 5 6 0 0 14
back to the original color.
E. There has been a significant darkening back to 0 0 0 0 11
the original color.
1. Have you had to have any crowns (caps) on any
of the teeth you treated?
Yes 0 0 0 0 0
No 100 100 100 100 100
2. Have you had to have any root canals or any
treatment to the nerve on any of the teeth you
treated?
Yes 0 0 0 0 3
No 100 100 100 100 97
3. Have you had any sensitivity with an y of the teeth
you treated since ending the treatment process that
may be treatment-related?
Yes 5 5 0 5 0
No 95 95 100 95 100
4. Have you had any gingiva (gum) sensitivity since
ending the treatment process that may be
treatment-related?
Yes 0 0 5 0 0
No 100 100 95 100 100
5. Are you glad you went through this treatment
process?
YeS 95 90 55 48 97
No 5 10 45 52 3
6. Would you go through this treatment process again?
YeS 4 85 63 47 83
No 6 15 37 53 17
7, Would you recommend this treatment procedure
to a friend?
YeS 94 95 53 44 93
No 6 5 47 56 7
8. Do your teeth normally get sensitive after a
tooth cleaning?
Yes NA 30 NA 11 6
No NA 70 NA 89 94
9. Are your teeth normallg sensitiveto hot and cold?
Yes NA 30 NA 30 19
No NA 70 NA 70 81
10. Do you think your ttah ate whiter now than before
Crcatingb?
“yes NA NA NA NA 76
NO NA NA NA NA 24

‘ R q C 3655ma

V O L U M E 13, N U M B E R 6, 2001 361

 N I G H T G U A R D V I T A L B L E A C H I N G : A L O N G - T E R M S T U D Y ON E F F I C A C Y .
SHADE R E T E N T I O N . S I D E E F F E C T S . A N D P A T I E N T S ’ P E R C E P T I O N S
control group (baseline4 mo post
treatment), active group (baseline-
6 mo post treatment), and combined
group (47-mo post treatment, range,
36-55 mo, for the active group and
crossover control group).
S TAT1STI C A L AN A LY S I S
Shade Change
The averaged shade values of the
four teeth were analyzed using a
weighted least-squares approach
for a repeated measures analysis
of variance (ANOVA) (PROC
CATMOD, SAS).34This approach
analyzes the mean response func-
tions and partitions the variation
in shade scores (ordinal in nature)
among the possible sources of time
(baseline, 7 and 14 treatment days,
3 and 6 months post treatment),
treatment group (control and
active), and time by treatment
interaction (the pattern of change
over time for the two bleaching
groups). Contrasts within treat-
ment groups over time and
between treatment groups at base-
line, after 7 and 14 treatment days,
and a t 3 and 6 months post treat-
ment were performed within the
general linear model using the
design matrix from the repeated
measures procedures. Contrasts
between baseline, day 14 of treat-
ment, and 4 7 months post treat-
ment for the combined group were
analyzed using a similar weighted
least-squares approach for a
repeated measures ANOVA, where
the possible source of variation was
time (baseline, 14 days of treat-
362 JOURNAL O F E S T H E T I C A N D R E S T O R A T I V E D E N T I S T R Y
ment, and 47 months post treat-
ment). Level of significance was set
at p < .05.
Safety Measures
The Savage test, a nonparametric
test, was used to analyze the data.
This test allowed for the compari-
son of the groups at baseline, 7 and
14 treatment days, and 3, 6, and
4 7 months post treatment for GI,
PI, NMGI, NGOMI, and TV, Level
of significance was set at p < .lo.
RESULTS
Demographics
Fifty-one participants were enrolled
in the study and randomized to
receive either an active or control
treatment solution. Forty-eight
participants completed the initial
portion of the study through the
6-month post-treatment appoint-
ment (24 placebo and 24 active,
retention rate 94%). Owing to
sickness or inclement weather, one
in the control group (96% show
rate) and two in the active group
(92% show rate) missed their
3-month evaluation.
For the participants who completed
the 6-month portion of the study,
90% were Caucasian and 58%
were female. The average age of the
participants was 41.2 years (SD =
11.95 yr) and ranged from 18.9 to
73.1 years. There was no statisti-
cally significant difference in the
mean age, gender, oral health status,
or baseline shade of the participants
randomized to the two groups
( p > .80). The nightguard was
worn an average of 7.2 hours per
day for the control group (range,
6.2-8.7 hr) and 7.3 hours for the
active group (range, 6.1-8.1 hr)
(Table 3 ) . Thirty-one of the possible
41 participants (76%) completed
the study through the 47-month
post-treatment appointment: 1 7 of
the 24 from the original active group
and 14 of the 17 control crossover
group. Twenty-three participants
were seen clinically, and all 31 com-
pleted a 47-month post-treatment
questionnaire. Six participants had
re-treated their teeth upon the recall
appointment. Clinical data gathered
from the six participants who had
re-treated their teeth were not
included in the study, since it would
skew the results, especially the
retention of shade. Only data gath-
ered from the questionnaire were
included in the study.
EFFICACY A N D R E T E N T I O N
O F SHADE C H A N G E
There was a significant interaction
between time and treatment among
the groups. Clinically, the efficacy
rate for the participants in the com-
bined group was 98% after 2 weeks
of treatment, and this whitening
effect was evident in 82% of the
participants (at least a two-shade
value-oriented change) a t 4 7
months post treatment. In the con-
trol group, the shade scores did
not change significantly over time
( p = .lo). For the active group, the
median shade scores a t baseline
were significantly different from
 I I (I\ \KI) I i \I

TABLE 3 . PATIENTS’ PERCEPTIONS OF A NIGHTGUARD VITAL BLEACHING PROCEDURE

Parameter Control (n = 24) Active (n = 24)
Average hours per day worn (range) 7.2 (6.2-8.7) 7.3 (6.1-8.1 I
Reported tooth sensitivity 21% (n = 5 ) 25% ( n = 6 )
Days of tooth sensitivity (range) 8.2 (1-14) 6.2 (1-12)
Reported gingival irritation 4% (n = 1) 8 % (n = 2)
Days of gingival irritation (range) 3.0 (3.0) 1.5 (1-2)
Reported tooth sensitivity and gingival irritation 13% (n = 3) 33% (n = 8)
Days of both (range) 7.0 (1-14) 5.8 (1-12)
Active group: females reported more tooth sensitivity (50%)than males (25%); females reported more gingival irritation (30%)than males (20%);
patients < 40 yr of age reported more gingival irritation
patients S 40 yr of age reported more tooth sensitivity (50%) than those > 40 yr (U%);
(30%)than those > 40 yr (20%);and mean first day of shade change noted was day 4 (range, 1-14 d).
Control crossover group: 24% (4117)reported TS or Gm when using a placebo, and 59% (10117)reported TS or Gm when using the active
whitening solution.

scores after 7 and 1 4 days of treat-
ment and the 3- and 6-month
post-treatment scores ( p < .0001
in every case). The change in the
shade scores for the combined
group from baseline to 14 days of
treatment and at 47 months post
treatment was also significantly
ing shade change over time and after 7 and 14 treatment days,
total shade change. Photographs or a t 3 and 6 months post treat-
of three participants in the active ment for any safety measure
group are shown in Figures 2 to 4. ( p > .10 at all time periods). The
same was true for the combined
S A I - F 1 \r h l L . l 5 U l i F < group (Table 5).
Gingival Index, Plaque Index,
Nonmarginal Gingival Index, T O O T H VIT.4LITI

different ( p < .OOO I ). The control Nongingival Oral Mucosal Index There were no statistically signifi-
and active groups did not differ There were no ststistically signifi- cant differences between the active
significantly at bdscline ( p = .08). cant differences between the active and control groups with respect to
Table 4 presents the data regard- and control groups at baseline, tooth vitality a t baseline, 7 and 14

TABLE 4. M E D I A N VITA SHADE VALUES OF CONTROL, ACTIVE, AND COMBINED GROUPS DURING WHITENING STUDY.
7 Days 14 Days 3 Months 6 Months 47 Months
Group Baseline Treatment Treatment Post Treatment Post Treatment Post Treatment*
Control (median value) 10.0 10.0 10.0 10.0 10.0 -

Experimental (median value) 10.0 3.0 2.0 3.0 4.0 -

Experimental group change from - 7 8 7 6 -

baseline (Vita units)
Combined group (median value) 10.0 - 3.0 - - 5.0
Combined group change from - - 7 - - 5
baseline (Vita units)
-____I_-____.____
“Range, 36-55 mo.
After 2 weeks of treatment, 92% of the participants presented with at least a 2 Vita shade change.
At an average of 47 months post treatment (range, 36-55 mo), 82% of participants presented with at least a 2 Vita shade change.

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 N I G H T G U A R D V I T A L B L E A C H I N G : A L O N G - T E R M S T U D Y ON E F F I C A C Y .
SHADE R E T E N T I O N . S I D E E F F E C T S . A N D P A T I E N T S ’ P E R C E P T I O N S

days of treatment, or 3 and 6
months post treatment or for the
combined group at baseline and 47
months post treatment ( p > .lo).
RADIOGRAPHIC EVALUATION
Evaluation of radiographs by three
examiners revealed no detectable
difference between the pre- and
6-month post-treatment radio-
graphs with respect to pulpal
chamber size, widening of the lam-
ina dura. internal or external
resorption, or any other periapical
changes in either group. Figure 5
presents pre- and post-treatment
radiographs of a participant in the
active group.
LOG FORM INFORMATION
AND Q U E S T I O N N A I R E RESULTS
Tables 2 and 3 present Patients’
Perceptions ofT& Girry and
change during the course of the study-

Figure 2. Vitn shade of a patient: A, baseline, C3: B, 48 months after treatment, B1.

Figwe 3. Vita shade of a patient: A, baseline, A3: B, 36 months after treatment, B2.

Figure 4. Vitn shade of a patient: A, baseline, A3; B, 48 months after treatment, A2.

364 JOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY

 ~ ~~~

TABLE 5 . SAFETY ISSUES: M E A N VALUES WITH STANDARD DEVIATION OVER TIME DURING A NIGHTGUARD VITAL
BLEACHING STUDY.
-~ ~
. I-___

Post Treatment
Baseline 7 Days 14 Days 3 Months 6 Months 47 Months
index Mean (SD) Mean (SD) Mean E D ) Mean (SD) Mean (SD) Mean (SD)
Gingival
Control 0.03 (0.06) 0.03 (0.07) 0.01 (0.03) 0.01 (0.04) 0.03 (0.10) NA
Active 0.05 (0.13) 0.03 (0.06) 0.02 (0.05) 0.02 (0.06) 0.01 (0.02) NA
Combined NA NA NA NA NA 0.03 (0.04)
Plaque
Control 0.07 (0.13) 0.08 (0.16) 0.07 (0.22) 0.07 (0.14) 0.14 (0.22) NA
Active 0.15 (0.19) 0.09 (0.16) 0.07 (0.15) 0.14 (0.20) 0.09 (0.14) NA
Combined NA NA NA NA NA 0.12 (0.15)
Nonmarginal gingival
Control 0.0 0.0 0.0 0.0 0.0 NA
Active 0.0 0.0 0.0 0.0 0.0 NA
Combined NA NA NA NA NA 0.0
Nongingival oral mucosa
Control 0.0 0.0 0.0 0.0 0.0 NA
Active 0.0 0.0 0.0 0.0 0.0 NA
Combined NA NA NA NA NA 0.0
*Range, 3 6 5 5 mo.

Figure 5. Radiographs: A, pretreatment; B, 6 months post treatment. All teeth were

vital with no signs of decay, fracture, internal or external resorption, or other pul-
pal pathology.

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 N I G H T G U A R D V I T A L B L E A C H I N G : A L O N G - T E R M S T U D Y ON E F F I C A C Y .
SHADE R E T E N T I O N . S I D E E F F E C T S . A N D P A T I E N T S ’ P E R C E P T I O N S
At 3 , 6 , and 47 months post treat-
ment, participants were given a
questionnaire to complete concern-
ing their perceptions of the NGVB
procedure. Responses are presented
in Table 2.
DISCUSSION
Results of this study concur with
those of previously reported studies
that NGVB using a 10% CP
whitening solution according to the
manufacturer’s instructions is effi-
cacious and safe, with minimal side
effeas.177~1s-30 One of the objectives
of this NGVB double-blind study
was to determine the clinical effi-
cacy and duration of efficacy of a
highly viscous 10% CP whitening
solution at 3 , 6 , and 47 months
post treatment. Clinically, the effi-
cacy rate for the participants in the
combined group was 98%, and at
47 months post treatment, the
median shade was five units lighter
than at baseline (see Figures 2-4
and Table 4). Ninety-two percent of
the participants in the active group
had at least a two-shade change
from baseline after 2 weeks of
treatment, and at 6 months post
treatment, 88% still showed at least
a two-shade change. This is well
beyond the two-unit shade change
as set forth in the ADA guidelines
for peroxide-containing oral
hygiene products.31 Eighty-two
percent of the combined group had
at least a two-shade change from
baseline a t a mean of 47 months
post treatment. The shade change
for the active solution used in this
366 JOURNAL OF ESTHETIC A N D RESTORATIVE DENTISTRY
study was similar to that reported The patients’ perception of shade
for other peroxide-containing change in all groups corresponded
whitening s ~ l u t i o n s . ’ ~ ~ ~ - ” ~ ’ ~well
~ ~ with
~ the examiners’ clinical
evaluation. With respect to the
For the first 6 months, this was a active group at 6 months post treat-
double-blind study, although it may ment, 94% reported no obvious
have been possible for the dentist color change or only a slight dark-
and patient to guess which partici- ening. For the combined group,
pant may have received the active 75% reported no obvious change or
solution or the control solution. only a slight darkening at 47 months
This is a disadvantage of any post treatment. This corresponds to
whitening study, since the results the darkening seen clinically by the
are often quick and dramatic. examiners. In addition, 90% of the
However, it should be pointed out active participants at 6 months post
that not all patients receiving an treatment believed their teeth were
active whitening solution would lighter than at baseline, and 76% in
respond positively (teeth getting the combined group at 4 7 months
lighter) to the whitening solution. post treatment believed their teeth
Likewise, a small percentage of the to be lighter than at baseline.
patients receiving a placebo solution Twenty-five percent thought moder-
perceived a shade change in which ate or significant darkening had
their teeth appear lighter. This occurred by the 47-month post-
placebo effect has been document- treatment appointment. Six of the
ed in other s t u d i e ~ . Thus,
‘ ~ ~ ~it~is participants had re-treated their
critical for examiners to be as teeth during the study. The average
objective as possible when deter- period post treatment for re-treating
mining shade changes of partici- was 32 months (range, 24-42 mo).
pants in a NGVB research study. This is similar to findings in
another study in which the average
Several methods of determining time to re-treat post treatment
tooth shade presently exist in was 25 m0nths.l In light of this
dentistry: colorirneter, computers, information, patients should be
shade guides, etc. For this study, informed of the lack of need to rou-
the Vita shade guide was used, tinely re-treat their teeth, especially
since it is familiar among practicing on a monthly basis.
dentists, economical, practical, and
often used in research ~ t u d i e s . ~ ~ A J ~second
. ~ ~ objective of this study
In addition, when the Vita shade was to determine the side effects
guide is arranged in order of value, of an active 10% CP whitening
it makes shade selection easier solution. No statistically significant
and more predictable when whiten- differences were noted for GI, PI,
ing teeth.36 NMGI, NGOMI, or TV between
 baseline and 7 or 14 days of treat- groups for TV at baseline and after The third objective of this study
ment and 3 or 6 months post treat- 7 and 14 days of whitening or at was to evaluate the patients' per-
ment ( p > .lo). The same was true baseline and 3 and 6 months post ceptions of side effects by use of log
for the combined group at 47 treatment or for the combined forms completed by the participants
months post treatment ( p > .lo). At group at baseline and 47 months during treatment and question-
baseline, the Loe-Silness GI score post treatment ( p > .lo). Although naires completed by the participants
for participants in the active group thermal pulp testing is not an at 3, 6, and 47 months post treat-
was 0.05, which ranked them, on absolute indicator of pulpal pathol- ment. During the active phase of
average, as having normal gingiva. ogy, it provides important informa- the study, fewer participants in the
Throughout the study, their mean tion in classifying pulpal condi- control group (38%) reported TS
GI changed little (14 days of tions. Prolonged and persistent or Girr than in the active group
treatment = 0.02, 3 months post pain for several minutes or longer (66%)(see Table 3 ) . With respect
treatment = 0.02, 6 months post induced by thermal changes may to the control crossover group,
treatment = 0.01). Range of scoring indicate irreversible pulpal 24% (4/17) reported TS or Girr
for individual teeth for the GI was p a t h ~ s i sNone
. ~ ~ of the participants when using the placebo whitening
0 to 2. Scores and ranges were simi- experienced such discomfort when solution and 59% (10/17)when
lar for the control group. N o score being tested with Histofreeze 2000. treating their teeth with the active
of 3 for any tooth (i.e., an ulcera- At the 6-month post-treatment whitening agent. No one in the
tion and tendency to bleed sponta- appointment, only 2 of the 90 teeth combined group at 47 months post
neously) was reported. The same responding to Histofreeze at base- treatment reported TS or Girr that
can be said for the PI, NMGI, and line in the active group did not they thought was treatment related.
NGOMI. Participants entered the respond; in the control group, 3
study with low PI, NMGI, and did not respond. For the combined At the 6-month post-treatment
NGOMI scores, and scores group, 5 of 92 teeth did not respond. evaluation, participants were ques-
remained low throughout the study, One participant in the active group tioned about their pretreatment TS
with no one presenting to the clinic reported having to have a root and Girr. Although it would have
with an ulceration or soft-tissue canal during the study; however, it been more accurate to ask these
irritation that was believed to be could not be concluded that it was questions pretreatment, owing to
treatment-related. It can be con- treatment-related. Radiographic oversight, they were not. Thirty
cluded that using a 10% CP evaluation confirmed the presence percent of the active group and
whitening solution according to the of the root canal and the absence 30% of the control group reported
guidelines of this study has minimal of periapical changes in the other having sensitive teeth pretreatment.
side effects on the oral soft tissue study teeth in the active and control Thirty percent of the active group
with no long-term effect at an aver- groups. Radiographic evaluation also reported their teeth being sen-
age of 4 7 months post treatment did reveal that two teeth were sitive after prophylaxis, whereas
(range, 36-55 mo). Other studies restored with Class I11 composite only 11% of the control group
have reported similar f ~ n d i n g s . ' J ~ ~restorations
~>~~ during the 6-month reported sensitivity after prophy-
post-treatment study period, both laxis. Although the percentages of
Tooth vitality was evaluated by on patients in the control group. positive responses changed with the
Histofreeze 2000. No statistically No one in the combined group combined group, the difference in
significant difference existed presented to the clinic with a crown the pretreatment sensitivity and,
between the control and active on the study teeth. especially, sensitivity after a pro-

VOLUME 13, NUMBER 6 , 2 0 0 1 367

 N I G H T G U A R D V I T A L B L E A C H I N G : A L O N G - T E R M S T U D Y ON E F F I C A C Y .
SHADE R E T E N T I O N . S I D E E F F E C T S . A N D P A T I E N T S ’ P E R C E P T I O N S
phylaxis between the active and
control groups may help explain the
difference seen in TS or Girr during
the active phase of treatment, since
all participants received prophylaxis.
All side effects seemed to be tran-
sient and disappeared spontaneously
or after cessation of the study. It is
important to note that no one quit
the study or delayed completion of
the study because of TS or Girr. At
the 3-month post-treatment
appointment, only one participant
in each group reported TS or Girr
that they thought was treatment-
related. One participant in the
active group reported sensitivity at
6 months post treatment; however,
this participant did not report any
sensitivity at 3 months post treat-
ment. No one in the combined
group reported TS or Girr that they
thought was treatment-related.
These results concur with those of
a previously reported study.
Why some participants develop
mild side effects during treatment
and others do not is not fully
understood, since all participants
are exposed to the same chemical
by-products of carbamide peroxide
degradation. The TS and Girr levels
noted in this study could be attrib-
utable to the fit of the tray. A poly-
vinyl siloxane impression material
was used instead of the more com-
monly used alginate impression
material, which may have led to
a more accurate cast and thus a
tighter fitting tray. It has been pos-
tulated that the following could
also contribute to TS or Girr:
368 JOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY
variations in vehicle base, variations
in the type and amount of thicken-
ing agent added for sustained release
of the active whitening solution, pH
of the whitening solution, chemical
by-products of the CP (especially
free radicals) and tray material,
exposure time to the whitening solu-
tion, concentration of the whitening
solution, medical condition of the
patient, pulp size, gender, age, and
tooth characteristic^.^^,^^ As sug-
gested in a previous the
reason for TS or Girr is multifactor-
ial, and additional research is
needed in this area. At any rate,
TS and Girr seem to resolve either
spontaneously or after cessation of
NGVB. It is important to reiterate
that 38% of the control group expe-
rienced TS or Girr, indicating that
the peroxide is not the sole irritant.
Participants who received the active
whitening solution were overwhelm-
ingly positive about the NGVB
procedure. More than 90% of the
participants at all recall periods
indicated that they were glad they
went through the NGVB procedure
and would recommend it to a friend.
However, 15% of the participants
surveyed at 6 months post treatment
indicated that they would not go
through the procedure again. This is
almost three times higher compared
with the 3-month results. The per-
centage was slightly higher (17%)at
47 months post treatment. An inter-
esting fact is that this same group of
participants also reported a darken-
ing of their teeth, which was con-
firmed clinically by the examiners.
CONCLUSIONS
The results of this study concur
with those of previously reported
studies that NGVB using a 10% CP
whitening solution according to the
manufacturer’s instructions is effi-
cacious and safe, with minimal side
effects. The 10% CP whitening
solution used in this study was
effective in lightening teeth (efficacy
rate of 98%), and the effect was
sustained at 47 months post treat-
ment (range, 36-55 mo) in 82%
of participants. When evaluating
safety issues, such as GI, PI, NMGI,
NGOMI, TV, and radiographic
changes, there were no statistically
significant adverse effects between
an active 1 0 % CP whitening solu-
tion and a control. Overall, the
participants receiving the active
whitening solution were glad they
went through the process and
were overwhelmingly positive
about the procedure in terms of
shade retention and lack of post-
treatment side effects.
DISCLOSURE A N D
ACKNOWLEDGMENTS
This study was partially funded by
Discus Dental Inc.
The authors have no financial inter-
est in any of the companies or
products mentioned in this article.
The authors acknowledge Ms. Judy
Dow for helping with the manu-
script and Drs. Gustavo Gari and
Van Haywood for their invaluable
support on this project.
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Presented in part at the Annual Session of
the IADR, Orlando, FL, March 19-23,
1997, and Chicago, IL, March 7-1 0,2001.
This study was partially funded by Discus
Dental Inc.
Reprint requests: Ralph H. Leonardlr.,
DDS, MPH, University of North Carolim
School of Dentistry, 179 Dental Buikfing,
Chapel Hill, N C 27599-7450; e-mail:
Ralph-LeonardOdentistry-ttnc.edu
02001 BC Decker Inc
V O L U M E 13, N U M B E R 6 , 2001 369