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Abstract Introduction
This randomized split-mouth controlled clinical
trial aimed at assessing the therapeutic effects of
infiltration vs. sealing for controlling caries pro-
gression on proximal surfaces. Out of 90 adult
W ith modern dentistry, preservation of the dental structure and avoidance
of surgical treatment have become treatment goals (Ekstrand et al.,
2001, 2009; Kielbassa et al., 2009; Splieth et al., 2009). Consequently, suc-
students/patients assessed at university clinics and cessful non-operative treatment initiatives have been developed, such as seal-
agreeing to participate, 39, each with 3 proximal ing of proximal early lesions (Martignon et al., 2006, 2010a) and infiltration
lesions identified radiographically around the with a resin capable of effectively penetrating the lesion pores (Paris et al.,
enamel-dentin junction to the outer third of the 2007; Meyer-Lueckel and Paris, 2008). Studies in young adults (Paris et al.,
dentin, were included. Lesions were randomly 2010) and children (Ekstrand et al., 2010) have shown a significantly higher
allocated for treatment to test-A (Infiltration:
efficacy of resin infiltration on early proximal lesions after a short period of
ICON-pre-product; DMG), test-B (Sealing: Prime-
Bond-NT; Dentsply), or control-C (Placebo). time in comparison with placebo or conventional non-operative measures.
Primary outcome after 1, 2, and 3 yrs of radio- This study was conducted on young adults with the aim of comparing the
graphically observed lesion progression was therapeutic effects of infiltrating vs. sealing proximal caries lesions and pla-
assessed by an independent examiner blinded to cebo treatment after 1, 2, and 3 yrs. The outcome (lesion progression) was
groups, using pair-wise and digital-subtraction evaluated by radiographic techniques.
readings. No adverse events occurred. In 37 par-
ticipants assessed after 3 yrs, 10 lesions (A-4; B-2;
C-4) progressed deep into dentin and needed oper- Materials & Methods
ative treatment. The 3-year therapeutic effect, This split-mouth placebo-controlled randomized clinical trial was conducted
based on pair-wise radiographic readings between
on 16- to 35-year-old individuals in Bogotá, Colombia. Sample size calcula-
infiltration and placebo, was 37.8% (95%CI: 20.5-
55.2%) and that between sealing and placebo was tion was based on parameters from a previous proximal sealing study
29.7% (95%CI: 20.2-35.0%). One-year follow-up (Martignon et al., 2006): difference of control (84%) vs. test (43%) progres-
digital-subtraction readings showed significant sion percentages (41%); and proportion of discordant pairs (56%), α = 0.05,
differences in lesion progression between infiltra- 1–β = 0.8. The calculated sample size was 22 persons. With an expected 30%
tion and placebo (P = 0.0012) and between sealing drop-out after 3 yrs, at least 29 participants were to be included.
and placebo (P = 0.0269). The study showed that Ethical approval was obtained from the Ethical Board at the Universidad
infiltration and sealing are significantly better than El Bosque (IRB-089, 2008) (protocol available).
placebo treatment for controlling caries progres- The study population was comprised of students/patients from Universidad
sion on proximal lesions. No significant difference El Bosque who were approached in 2008 for participation in the 3-year study.
was seen between infiltration and sealing Exclusion criteria and study flow are outlined in Fig. 1. The study was
(ClinicalTrials.gov number CT01417832).
explained to potential participants by two of the authors (JSL, AC), who
informed them that infiltration and sealing are alternative preventive treat-
KEY WORDS: caries treatment, clinical studies/ ments for early proximal lesions, and that 2 initial bitewing radiographs
trials, radiography, resin(s), caries detection/diag- would be made to search for 3 of these lesions. Of the 680 people approached,
nosis/prevention, preventive dentistry. 90 agreed to participate (providing written informed consent) in the study and
had the first set of radiographs made.
DOI: 10.1177/0022034511435328
In all cases, participants were referred for operative treatment if needed.
Received September 28, 2011; Last revision December 06,
To be included in the study, participants were required to have at least 3 radio-
2011; Accepted December 12, 2011 graphically observed caries proximal lesions in the posterior teeth, with a
score of 3 or 4 (SM) in the following modified radiographic scoring system
© International & American Associations for Dental Research (Martignon et al., 2006): 0, no radiolucency; 1, outer half of enamel; 2, inner
288
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Table. Distribution of the Randomly Selected Lesions (A, B, C) According to Tooth Surface and Radiographic Score
Tooth 14/24 15/25 16/26 17/27 34/44 35/45 36/46 37/47 Total
Surface M D M D M D M D M D M D M D M D
Infiltration (A)
Score 3 1 1 2 1 1 0 0 0 0 1 1 6 1 1 0 0 16
Score 4 0 1 3 6 4 1 0 0 0 0 1 3 3 1 0 0 23
Sealing (B)
Score 3 0 3 0 0 2 0 0 0 0 0 1 5 2 1 0 0 14
Score 4 0 8 5 3 2 0 0 0 0 0 1 3 1 1 1 0 25
Placebo (C)
Score 3 0 2 2 2 0 2 1 0 0 1 3 2 0 0 0 0 15
Score 4 0 2 4 5 1 2 1 0 0 1 1 4 1 2 0 0 24
Total 1 17 16 17 10 5 2 0 0 3 8 23 8 6 1 0 117
Results
Baseline
The sample included 28 women and 11 men, with a mean age of
21 yrs (range, 16-31 yrs). The mean DF-T of the sample was 4.9
± 3.4, and the DF-S corresponded to 7.0 ± 5.9 (D-S, 0.6 ± 1.0;
F-S, 6.4 ± 6.0). No teeth were extracted due to caries (M). More
than half of the participants were classified as ‘moderate-very
high’ caries risk (moderate, 28%; high, 21%; very high, 5%),
and the rest (46%) as low caries risk.
The Table demonstrates that most of the selected lesions
Figure 2. Radiographic pair-wise reading progression of proximal (61.5%) were radiographically classified as score 4; the majority
lesions after 1, 2, and 3 yrs.
were located in the upper teeth (58.1%), and, with respect to tooth
type, more than half were in the second premolars (54.7%).
and 3 yrs, only pair-wise radiograph readings were conducted. For The visual assessment revealed that the majority (88%) of
all readings, the examiner was blinded to whether the lesion was an the selected proximal lesions had an ICDAS score of 2 (A, 90%;
A, B, or C (placebo) lesion. For the pair-wise readings, the most B, 87%; C, 87%), followed by a score of 3 (5%). In 4 cases
recent film was coded and then read against baseline. For reproduc- (3%), the lesion could not be visually assessed. Activity was
ibility assessment, the examiner repeated 20% of radiograph read- assessed in 80/117 lesions (68.4%); in 37 cases, visual and/or
ings by both methods 1 wk after the first reading. tactile access of lesions was not possible. Of these, 64.9% were
premolar teeth. Of the 80 lesions, 26/27 in group A, 26/27 in
Statistical Analysis group B, and 24/26 in group C were assessed as active.
The intra-examiner reliability for the pair-wise and the digital-
subtraction radiographic readings was assessed by unweighted Follow-up
kappa scores (Landis and Koch, 1977). Caries experience (DMF- Only two participants (5%), one during the first and one during
T/S), individual caries risk levels, ICDAS criteria, radiographic the second year, dropped out of the study. No unwanted side-
scores, and progression status of selected lesions were reported effects (pain, vitality loss, staining) were observed. During the
descriptively. The outcome variable of lesion progression during study period, 10 cases (A-4; B-2; C-4) showed radiographic
the 1-, 2-, and 3-year study period was assessed by pair-wise radio- lesion progression reaching the middle third of dentin and were
graphic reading. Results of the digital-subtraction radiography were referred for operative treatment.
reported after 1 yr only. The placement of a restoration during the
study period was considered as lesion progression. Differences in
Pair-wise Reading of Radiographs
lesion progression between treatments at each follow-up were ini-
tially tested by the Cochran Q test (Siegel and Castellan, 2002). In Fig. 2 demonstrates the 1- (n = 38), 2- (n = 37), and 3-year pro-
case of significant difference between groups, the McNemar gression results (n = 37) of the pair-wise readings. Three-year
Change test for related groups was conducted, including the percentages were: 32% infiltrated, 41% sealed, and 70% placebo
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caries lesion’s surface layer is remineralized, but its thickness Ekstrand KR, Brunn G, Bruun M (1998). Plaque and gingival status as
becomes significantly reduced after HCl etching compared with indicators for caries progression on proximal surfaces. Caries Res
32:41-45.
that achieved with phosphoric-acid etching (Paris et al., 2007). Ekstrand KR, Ricketts DN, Kidd EA (2001). Occlusal caries: pathology,
Thus, it could be argued that if the eroded etched surface is not diagnosis and logical management. Dent Update 28:380-387.
properly infiltrated, lesion progression could then be facilitated. Ekstrand KR, Martignon S, Ricketts DJ, Qvist V (2007). Detection and
In this study, the temporary-elective separation allowed for activity assessment of primary coronal caries lesions: a methodologic
the visual/tactile access of the proximal surfaces, facilitating the study. Oper Dent 32:225-235.
Ekstrand KR, Zero DT, Martignon S, Pitts NB (2009). Lesion activity
ICDAS-severity and activity scoring of the lesions. Most lesions assessment. In: Detection, assessment, diagnosing and monitoring
were classified as ‘Distinct visual change in enamel’, and 5% as of caries. Monogr Oral Sci 21. Pitts N, editor. Basel: S. Karger,
‘Localized enamel breakdown’ (microcavity) (A, 2; B, 3; C, 1), pp. 63-90.
confirming correlation between visual and radiographic scores Ekstrand KR, Bakhshandeh A, Martignon S (2010). Treatment of proximal
with the ICDAS system on proximal surfaces (Ekstrand et al., superficial caries lesions on primary molar teeth with resin infiltration
and fluoride varnish versus fluoride varnish only: efficacy after 1 year.
2011). The majority of the lesions were scored as active, sup- Caries Res 44:41-46.
porting the activity assessment and non-invasive management Ekstrand KR, Luna LE, Promisiero L, Cortes A, Cuevas S, Reyes JF, et al.
of these lesions (Ekstrand et al., 2009). (2011). The reliability and accuracy of two methods for proximal caries
The progression rates shown in all groups reinforce the man- detection and depth on directly visible proximal surfaces: an in vitro
agement of early lesions with non-operative interceptive treat- study. Caries Res 45:93-99.
Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, et al. (2007). The
ment, which highlights the need to select appropriate cases and International Caries Detection and Assessment System (ICDAS): an
requires recalls, as suggested in the ICDAS caries management integrated system for measuring dental caries. Community Dent Oral
flow diagram (Pitts and Richards, 2009). The alternative, a Epidemiol 35:170-178.
class-II cavity plus restoration, sacrifices dental structure and Kielbassa AM, Muller J, Gernhardt CR (2009). Closing the gap between oral
does not guarantee a 100% success rate (Qvist, 2008). The fact hygiene and minimally invasive dentistry: a review on the resin infiltra-
tion technique of incipient (proximal) enamel lesions. Quintessence Int
that 70% of placebo lesions progressed after 3 yrs, even after 40:663-681.
flossing instruction and within a health system that includes Landis JR, Koch GG (1977). The measurement of observer agreement for
systemic salt fluoridation and prevention activities, such as fluo- categorical data. Biometrics 33:159-174.
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Colombia, 1999), highlights the low compliance with flossing early active lesions: an 18-month clinical study evaluated by conven-
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(Martignon et al., 2010b) and emphasizes the need to improve Martignon S, Tellez M, Santamaría RM, Gomez J, Ekstrand KR (2010a).
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Digital-subtraction radiography, a more sensitive technique than after 2.5 years. Caries Res 44:562-570.
conventional pair-wise reading of radiographs (Ricketts et al., Martignon S, Chavarría N, Ekstrand KR (2010). Caries status and proximal
lesion behaviour during a 6-year period in young adult Danes: an epi-
2007), was used in this study after one year. This was performed to
demiological investigation. Clin Oral Investig 14:383-390.
allow for a short follow-up period to compare with other studies Mejàre I, Källestl C, Stenlund H (1999). Incidence and progression of
(Martignon et al., 2006; Paris et al., 2010) of similar duration. It approximal caries from 11 to 22 years of age in Sweden: a prospective
was not considered necessary to continue using it subsequently, radiographic study. Caries Res 33:93-100.
since pair-wise reading already showed differences between treat- Meyer-Lueckel H, Paris S (2008). Improved resin infiltration of natural car-
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ments at that follow-up. In normal clinical settings, dentists would
Ministerio de Salud–República de Colombia, Centro Nacional de Consultoría–
use pair-wise readings to assess caries progression. CNC (1999). Estudio Nacional de Salud Bucal. In: Ministerio de Salud,
The higher efficacy shown by pair-wise radiographic readings Centro Nacional de Consultoría–República de Colombia: III Estudio
after 3 yrs for the infiltration (68%) and for the sealing (60%) of Nacional de Salud Bucal–ENSAB III. Colombia: Lito Servicios Aler.
proximal lesions in comparison with a placebo (30%) makes these Tomo VII.
Paris S, Meyer-Lueckel H, Kielbassa AM (2007). Resin infiltration of natu-
approaches modern non-invasive alternatives for active lesions
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Acknowledgments Pitts N, editor. Basel: S. Karger, pp. 128-143.
Qvist V (2008). Longevity of restorations: the ‘death spiral’. In: Dental car-
The author(s) disclose receipt of financial support for the ies. The disease and its clinical management. Fejerskov O, Kidd E,
editors. 2nd ed. Singapore: Blackwell Munksgaard, pp. 443-455.
research, for travel expenses to discuss and/or present the study,
Ricketts DN, Ekstrand KR, Martignon S, Ellwood R, Alatsaris M, Nugent Z
and/or publication of this article from the DMG Dental-Material (2007). Accuracy and reproducibility of conventional radiographic
GmbH (Hamburg, Germany). The author(s) declared no poten- assessment and subtraction radiography in detecting demineralization
tial conflicts of interest with respect to the authorship and/or in occlusal surfaces. Caries Res 41:121-128.
publication of this article. Siegel S, Castellan NJ Jr (2002). The case of k related samples. In:
Nonparametric statistics for the behavioral sciences. Siegel S, Castellan
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