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66]
Original Article
Comparative evaluation of clinical and radiographic
success of three different lesion sterilization and tissue
repair techniques as treatment options in primary
molars requiring pulpectomy: An in vivo study
Amolkumar Lokade, Seema Thakur, Parul Singhal, Deepak Chauhan, Chiranjeevi Jayam
Department of Pediatric and Preventive Dentistry, HP Government Dental College and Hospital, Shimla, Himachal Pradesh, India
ABSTRACT
Introduction: Paediatric endodontics is part of
paediatric dental practice. Teeth with infected root
canals, particularly those in which the infection has
spread around the apical foramen and furcation area,
is a common problem in primary dentition for such
conditions pulpectomy is the procedure. Pulpectomy
procedure proves to be long and complicated and
has remained controversial for a number of reasons.
Lesion sterilization and tissue repair therapy (LSTR) is
a relatively new biologic approach for carious lesions
with or without pulpal and periapical involvement
using a mixture of antibiotics. Objectives: The aim of
this study was to evaluate clinical and radiographic
success of three different LSTR techniques as treatment
options in primary molars requiring pulpectomy.
Methods: Sixty‑three primary molars of fifty children
aged between 4 and 8  years with primary molars
requiring pulpectomy were treated with modified
3Mix‑MP antibiotic paste without removal of accessible
radicular pulp  (Group  I), modified 3Mix‑MP with
removal of accessible radicular pulp  (Group  II) and
Chloramphenicol,tetracycline and zinc oxide eugeno
(CTZ)  paste  (Group  III). The subjects were followed
up clinically at one, six, and twelve months whereas
radiographically at six and twelve months, respectively.
Results: The results showed that clinical success rates of
Group I, Group II and Group III were 90%, 90.5% and
81.8% respectively and radiographical success rates
were 75%, 76.2% and 63.6% respectively after twelve
months observation. Conclusion: On the basis of the
overall success rates of all the three LSTR techniques,
following order of performance can be inferred clinical
success and radiographical success: – 3Mix‑MP without
removal of radicular pulp = 3Mix‑MP with removal of
radicular pulp >CTZ paste.
KEYWORDS: CTZ paste, lesion sterilization and tissue
repair, modified 3Mix‑MP paste, noninstrumentation
endodontic treatment, primary teeth
© 2019 Journal of Indian Society of Pedodontics and Preventive Dentistry | Published by Wolters Kluwer ‑ Medknow
Address for correspondence:
Dr. Amolkumar Lokade,
Room No. 301, Department of Pedodontics and Preventive
Dentistry, HP Government Dental College, Shimla ‑ 171 001,
Himachal Pradesh, India.
E‑mail: LokadeAM@gmail.com
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DOI:
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Introduction
Endodontic treatment in primary teeth is aimed
primarily to remove all bacterial infection by
endodontic instrumentation and proper irrigation and
to obturate the root canals with a filling material. The
success of pulpectomy determined by resolution of the
clinical and radiological signs and symptoms, normal
exfoliation of treated primary tooth, and unimpeded
eruption of succedaneous tooth.[1]
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For reprints contact: reprints@medknow.com
How to cite this article: Lokade A, Thakur S, Singhal P,
Chauhan D, Jayam C. Comparative evaluation of clinical and
radiographic success of three different lesion sterilization and
tissue repair techniques as treatment options in primary molars
requiring pulpectomy: An in vivo study. J Indian Soc Pedod Prev
Dent 2019;37:185-91.
185
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Lokade, et al.: Comparative success of three different lesion sterilization and tissue repair techniques as treatment option in primary molar
requiring pulpectiomy: An in vivo study
Pulp therapy has been suggested since 1932 as a
method for maintaining primary teeth, which would
otherwise be lost.[2] Pulpectomy procedure proves
to be long and complicated and has remained
controversial for a number of reasons. Mainly, the
perceived difficulty of behavior management in the
pediatric population and uncertainty about the effects
of root canal filling material and instrumentation on
the succedaneous teeth. Anatomic situations like the
often complicated curved and tortuous shape of root
canals and the closeness of the advancing tooth buds
make the treatment more difficult.[3] Another limitation
is the apparent connection between the coronal floor
with the intraradicular area[4] with the presence of
multiple accessory canals and ramifications as well as
the difficulty in obtaining hermetic seal due to lack of
apical closure following physiologic root resorption
have surely added reluctance among dentists to use
this procedure. Hence, the use of such procedure
should be discouraged.[5]
A relatively new biologic approach, lesion sterilization
and tissue repair therapy  (LSTR) were introduced in
the treatment of carious lesions with or without pulpal
and periapical involvement using a mixture of three
broad spectrum antibiotics, namely, metronidazole,
ciprofloxacin, and minocycline (3Mix).[6] Modification
of 3Mix by using cefaclor in place of minocycline and
ornidazole in place of metronidazole has better clinical
results.[7,8] The rationale of LSTR is that mixture of
three antibiotics  (3Mix) can sterilize necrotic pulps
and infected root dentine of primary teeth. Repair
of damaged tissues can be expected if lesions are
disinfected. In the primary dentition, LSTR has
shown high rate of clinical success as a substitute for
pulpectomy.[9,10] However, radiographic success is
questionable in long‑term follow up.[11]
In this research to find an alternate treatment option
for tooth requiring pulpectomy, the present study
was undertaken to evaluate and compare clinical
and radiographic success of three different LSTR
techniques.
Methods
The study consisted of patients in the age group of
four–eight  years in which ethical approval from the
Institutional Ethical Committee and consent from the
parents/guardians were obtained. The criteria for
selection of teeth include first and second primary
molars (maxillary and mandibular) showing signs and
symptoms indicating pulpectomy:  (a) Spontaneous
pain or tender to percussion,  (b) Deep carious with
pulp exposure,  (c) Uncontrolled hemorrhage after
removal of coronal pulp tissue,  (d) Presence of
chronic apical abscess or sinus tract  (e) The tooth
should be restorable and radiographic characteristics:
(a) Coronal radiographic evidence of a deep carious
lesion involving pulp.  (b) Radicular–(i) discontinuity
186 Journal of Indian Society of Pedodontics and Preventive Dentistry | Volume 37 | Issue 2 | April-June 2019 |
of lamina dura (ii) Furcation involvement less than or
equal to half of shortest root in vertical dimension.
The teeth were excluded when nonrestorable or
presented with physiologic root resorption more
than a third of its length or if they had the presence
of obliteration of the root canal, excessive internal
resorption, internal calcifications, perforation into
the bifurcation, or any underlying dentigerous cysts.
Patients with any systemic illness or with previous
history of allergy to the antibiotics used in the study
were also excluded.
Clinical and radiographic information before treatment
was recorded by an operator. The enrollment of teeth
to either group was done randomly by envelope draw
method. All treatments were performed by same
operator.
• Group  one: Only the coronal pulp was removed
and the pulp chamber half filled with modified
3Mix antibiotic paste, sealed with glass ionomer
cement (GIC) and reinforced with stainless crown
after 15 days (20 teeth)
• Group  two: Both coronal as well as all accessible
radicular pulp tissue was extirpated and the
medication cavity half‑filled with modified 3Mix
antibiotic paste, sealed with GIC and reinforced
with stainless crown after 15 days (21 teeth)
• Group  three: Only coronal pulp tissue was
removed and the pulp chamber half filled with
CTZ paste, sealed with GIC and reinforced with
stainless crown after 15 days (22 teeth).
Clinical procedure for all three groups
Clinical procedure for Group I
Administration of local anesthesia and rubber dam
application [Figure 1a]
Initially topical anesthetic was applied at the site
of injection followed by nerve block for adequate
anesthetization of selected tooth [Figure 1a]. All cases
were treated under rubber dam.
a b c
d e f
Figure 1: (a) Application of rubber dam, (b) Access opening and pulp
extirpation, (c) Showing freshly mixed 3Mix-MP paste, (d) showing
freshly mixed CTZ paste, (e) Showing placement of modified 3Mix-MP
in cavity, (f) Restoration of teeth with stainless steel crown
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Lokade, et al.: Comparative success of three different lesion sterilization and tissue repair techniques as treatment option in primary molar
Access opening and pulp extirpation [Figure 1b]
Access to the pulp chamber was gained with a round
bur and proper access cavity was made using straight
fissure and tapering fissure bur. Spoon excavator was
used to remove bulk of the pulp or necrotic debris
from the pulp chamber.
Preparation of modified 3Mix‑MP paste [Figure 1c]
The chemotherapeutic agents used were ornidazole
tablets 500 mg (Ornida, Aristo pharmaceuticals, India),
ciprofloxacin tablets 500 mg (Ciplox®, Alchemist Ltd.,
India), and cefaclor tablets 250  mg  (Distaclor™ DT,
Baroque pharmaceuticals, India). After the removal
of enteric coating of tablets with the help of B.P blade,
the drugs are pulverized into fine powder using
sterilized mortar pestle. The powered drugs were kept
separately in amber colored air tight containers. The
fine powder was used up within a month. 3Mix‑MP
paste was freshly prepared for each use. The same
amount of each powdered drug  (1:1:1) was mixed to
form modified 3Mix powder. One part of propylene
glycol (P) and the same volume of macrogol (M) were
mixed to make MP. For standard preparation, one
part of MP and 7 parts of modified 3Mix powder were
mixed.
Placement of modified 3Mix‑MP in cavity [Figure 1e]
Modified 3Mix‑MP was then placed into pulp chamber.
Restoration of the tooth [Figure 1f]
After the placement of modified 3Mix‑MP paste, the
cavity was filled with GIC restoration in same visit.
The patient was then recalled after 15  days and the
tooth was then restored with stainless steel crown.
Clinical procedure for Group II
Same clinical procedure followed as Group  I only
difference is (The canals orifices were enlarged using
round bur to form medication cavity) medication
cavity is prepared at root canal orifice. Medication
cavity is a cavity with diameter one  mm and depth
two  mm and it acts as receptacle for medication and
accessible radicular pulp is extripated using H‑files
and filled with 3Mix‑MP paste, the cavity was filled
with GIC restoration in same visit. The patient was
then recalled after 15  days and the tooth was then
restored with stainless steel crown.
Clinical procedure for CTZ paste: (Group 3)
Same clinical procedure followed as Group 1 but pulp
chamber is filled with CTZ paste.
Preparation of modified CTZ paste [Figure 1d]
The chemotherapeutic agents used were tetracycline
(Tetracycline capsules, Resteclin® abbott healthcare
pvt.ltd), chloramphenicol (Chloramphenicol capsule,
500  mg Paraxin® abbott healthcare pvt.ltd.) After
the removal of enteric coating of capsules, the
drugs are pulverized one by one into fine powder
Journal of Indian Society of Pedodontics and Preventive Dentistry | Volume 37 | Issue 2 | April-June 2019 |
requiring pulpectiomy: An in vivo study
using sterilized mortar pestle. The powered drugs
were kept separately in amber‑colored air tight
containers. The fine powder was used up within a
month. CTZ paste was freshly prepared for each use
before or during treatment. Same amount of both
powdered drugs along with two parts of zinc oxide
powder  (Zinc oxide powder, DPI, Mumbai, India)
and drop of eugenol  (DPI, Mumbai, India) were
dispensed on clean glass slab and mixed to form
CTZ paste. The ratio of the mixture was tetracycline:
chloramphenicol: zinc oxide (1:1: 2). Along with One
drop of eugenol.
Clinical and radiographic evaluation
After treatment, clinical evaluation was done at one,
six and twelve while radiographic evaluations were
performed at six and twelve months. Blinded clinical
evaluations were performed by the operator. The
preoperative and follow up radiographs are shown
in   Figure  2  for the three groups. The radiographic
evaluations were carried out by two coinvestigators.
The intraexaminer reliability and interexaminer
reliability of the first and the second coinvestigators
were calculated by Cohen’s kappa statistic, i.e., 0.90
and 867, respectively, which indicates excellent level
of agreement. The criteria for clinical success include
the absence of pain, presence of healthy soft tissue,
and absence of abnormal mobility. The criteria for
radiographic success include static/reduction in size
of intra‑radicular radiolucency, evidence of bone
regeneration/continuity of lamina dura, and the
absence of internal/external resorption. The treatment
was judged to be successful when both clinical and
radiographic criteria were fulfilled. P <  0.05 was
considered statistically significant.
Results
Postoperative, follow up clinical examinations
at one, six and twelve  months are shown
in  Tables 1‑3.  Postoperative radiographic followup at
six and twelve months are shown in Tables 4 and 5.
Postoperative clinical findings
All teeth of three groups were clinically checked
at one  month postoperatively and 100% success
observed. At six  months, in group  I and group  II
showed 100% clinical success while in group  III
showed 90.9% of clinical success. At 12 clinical
follow up in group I there was 90% success observed
while in group  II and group  III the clinical success
were 90.5% and 81.8% respectively. No statistically
significant difference between the three groups was
observed for the clinical success at 1, 6 and 12 months
respectively [Graphs 1 and 2].
Postoperative radiological findings
At 6 months of radiological followup in all groups that
is group I, group II and group III there was 95%, 95.2%
187
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Lokade, et al.: Comparative success of three different lesion sterilization and tissue repair techniques as treatment option in primary molar
requiring pulpectiomy: An in vivo study

GROUP I

PREOPERATIVE SIX MONTHS FOLLOW UP TWELVE MONTHS FOLLOW UP

GROUP II

PREOPERATIVE SIX MONTHS FOLLOW UP TWELVE MONTHS FOLLOW UP

GROUP III

PREOPERATIVE SIX MONTHS FOLLOW UP TWELVE MONTHS FOLLOW UP

Figure 2: Radiographic success of all three groups preopratively and at six and twelve months follow up

Table 1: Clinical follow up at one month

Signs and symptoms Group 1 (n=20), n (%) Group 2 (n=21), n (%) Group 3 (n=22), n (%) Total (n=63), n (%) P Likelihood ratio
Pain 0 0 0 0 ‑ ‑
Gingival swelling 0 0 0 0 ‑ ‑
Mobility 0 0 0 0 ‑ ‑
Sinus tract 0 0 0 0 ‑ ‑
Premature loss of tooth 0 0 0 0 ‑ ‑

Table 2: Clinical follow up at six month

Signs and symptoms Group 1 (n=20), n (%) Group 2 (n=21), n (%) Group 3 (n=22), n (%) Total (n=63), n (%) P Likelihood ratio
Pain 0 0 2 (9.1) 2 (3.2) 0.146 4.332
Gingival swelling 0 0 2 (9.1) 2 (3.2) 0.146 4.332
Mobility 0 0 0 0 ‑ ‑
Sinus tract 0 0 2 (9.1) 2 (3.2) 0.146 4.332
Premature loss of tooth 0 0 0 0 ‑ ‑

Table 3: Clinical follow up twelve months

Signs and symptoms Group 1 (n=20), n (%) Group 2 (n=21), n (%) Group 3 (n=22), n (%) Total (n=63), n (%) P Likelihood ratio
Pain 2 (10) 2 (9.5) 4 (18.2) 8 (12.7) .632 .883
Gingival swelling 2 (10) 2 (9.5) 4 (18.2) 8 (12.7) .632 .883
Mobility 0 (100) 0 (100) 0 0 (100) - -
Sinus tract 2 (10) 2 (9.5) 4 (18.2) 8 (12.7) .632 .883
Premature loss of tooth -

and 90.9% success were observed however it was fell Discussion

to 75%, 76.2% and 63.6% at twelve months evaluation
respectively [Graphs 1, 2 and Figure 2]. No statistically
significantn difference between the three groups
was observed for the radiologicaal success at six and
twelve months respectively.
In group  I, there was 100% success observed at
1 month and at six months clinical evaluation, whereas
it was 90% at twelve  months follow up. This result
is comparable with Prabhakar et  al.[10]  (93.3%), Pinky

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Lokade, et al.: Comparative success of three different lesion sterilization and tissue repair techniques as treatment option in primary molar
requiring pulpectiomy: An in vivo study

Table 4: Radiographic follow up at six month

Radiological findings Group 1 (n=20), Group 2 (n=21), Group 3 (n=22), Total (n=63), P Likelihood
n (%) n (%) n (%) n (%) ratio
PDL enlargement 1 (5) 1 (4.8) 2 (9.1) 4 (6.3) 0.807 0.815
Increase in interradicular radiolucency 1 (5) 1 (4.8) 2 (9.1) 4 (6.3) 0.807 0.815
Internal resorption 0 1 (4.8) 2 (9.1) 3 (4.7) 0.073 0.047
External root resorption 0 0 0 0 ‑ ‑
Discontinuity of lamina dura 1 (5) 1 (4.8) 2 (9.1) 4 (6.3) 0.807 0.815
PDL=Periodontal ligament

Table 5: Radiographic follow up at twelve month

Radiological findings Group 1 (n=20) Group 2 (n=21) Group 3 (n=22) Total (n=63) P Likelihood ratio
PDL enlargement 5 (25) 5 (23.8) 8 (36.4) 18 (28.6) 0.603 0.608
Increase in interradicular radiolucency 5 (25) 5 (23.8) 8 (36.4) 18 (28.6) 0.603 0.608
Internal resorption 2 (10) 3 (14.3) 4 (18.1) 9 (14.2) 0.082 0.047
External root resorption 0 0 0 0 ‑ ‑
Discontinuity of lamina dura 5 (25) 5 (23.8) 8 (36.4) 18 (28.6) 0.603 0.608
PDL=Periodontal ligament

102 100 90 90.5

100 100
100 90 81.8
75 76.2
98
95.2 80
96 95 63.6
70
94
92 90.9 90.9 60
90 50
88 40
86 30
group 1 group 2 group 3
20
clinical success radiological success
10

Graph 1: Clinical and radiological success at six months 0

group 1 group 2 group 3

et al.[8] (90%) and Doneria et al.[12] (89.5). However, its
lesser than Takushige et  al.[9]  (100%) and Nakornchai
et  al.[13]  (100%) and more than Agarwal et  al.[14]  (28%)
and Trairatvorakul and Detsomboonrat[11]  (75%).
Radiographically there was 95.0% success observed
at six  months evaluation however it fell to 75.0% at
twelve months followup. The radiological success rate
of 75.0% is comparable with Nakornchai et al.[13] (76%).
However, it is lesser than as reported by Pinky
et al.[8] (90%) and Doneria et al.[12] (80.95%) but higher
than that of Prabhakar et  al.[10]  (63.3%) and Agarwal
et al.[14] (28%). These reported variations in success rates
may be attributed to differences in sample selection,
evaluation criteria and techniques employed.
Internal resorption and increase in intraradicular
radiolucency was found to be the most common
cause of radiological failure in group  I. A  total of
two teeth showed internal resorption while three
teeth were present with increase in radioluceny,
PDL enlargement, Discontinuity of lamina dura.
Previous investigations have also reported increase
in radiolucency and internal resorption as the most
frequent postoperative radiological failures observed
in primary molars after LSTR. Prabhakar et  al.[10] and
Pinky et al.[8] noted increase in bone loss in five teeth
clinical success radiological success
Graph 2: Clinical and radiological success at twelve months
and two teeth out of 30 and 20 teeth respectively.
Trairatvorakul and Detsomboonrat[11] reported total
38 failure cases when observed for 24 months. Out of
these failures, six teeth showed static radiolucency, 26
teeth showed increase in radiolucency and six teeth
showed internal resorption.
A study by Prabhakar et  al.[10] of 3Mix‑MP with
radicular pulp extripation group which showed
100% clinical and radiographic success at six and
twelve  months respectively however in the present
study group  II there is 100% clinical success at
six months which is in accordance with above study
but there is 95.2% radiological success at 6  months
which is lesser than the above study. However, in our
study, at twelve months clinical success is 90.5% and
the failures were due to pain and abscess in one tooth
and other tooth presented with pain and mobility and
radiologically there is success of 76.6% and failure
were due to four teeth showing internal resorption
along with increase in interradicular radiolucency
and other four teeth showed only increase in

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Lokade, et al.: Comparative success of three different lesion sterilization and tissue repair techniques as treatment option in primary molar
requiring pulpectiomy: An in vivo study
interradicular radiolucency. Comparative lesser
success rate observed in our group II as compared to
study conducted by Prabhakar et al.[10] May be due to
radiological success/failure criteria for assessment
taken.
The search of dental literature showed published
reports by  Moura et al.  (2016 and 2018)[15,16] in which
CTZ paste was used as LSTR agent in primary molars.
In our study CTZ paste is used in group  III and no
clinical failure was observed on one month follow up.
Whereas at 6  months clinical as well as radiological
follow up there was 90.9% success. The failure were
due to pain, gingival swelling, sinus tract formation
clinically and radiologically there was periodontal
ligament (PDL) enlargement, increase in interradicular
radiolucency, internal resorption, discontinuity of
lamina dura in both the cases. At twelve months clinical
and radiographic follow up there was 81.8% and 63.6%
success observed respectively. Clinically main reasons
for clinical failure was pain, gingival swelling and
sinus tract formation in all four teeth and radiologically
four teeth presented with internal resorption along
with increase in interradicular radiolucency and
other four teeth showed PDL enlargement, Increase
in interradicular radiolucency and discontinuity of
lamina dura. The twelve  months success rate of CTZ
in our study was lesser as compared to de Deus Moura
Lde et al.[15] (100% clinical and 93% radiographic). This
may be due to difference in evaluation criteria.
Clinical evaluation at six  months follow up showed
two failure in group III as compared to none in other
two groups, whereas at twelve months interval number
of clinical failures in first two groups augmented
to two each and in group  III it was four. However
statistically there was no significant difference between
the three groups for clinical success of treatment
P = 0.146 (6 months) and P = 0.632 (12 months).
Radiologically Group  I and II showed one failure
in each and two failures were seen in group  III at
six  months interval. Furthermore, at twelve  months
interval failures increased in all three groups to five
each in first two groups and eight in Group III. However
statistically there was no significant difference between
the three groups for Radiological success of treatment
P = 0.807 (6 months) and P = 0.603 (12 months).
Although the comparative results in the present study
at six and twelve  months interval were statistically
insignificant, Group  I and II showed slightly better
results than Group III.
The findings of our investigation indicate that modified
3Mix‑MP and CTZ LSTR therapies hold potential to be
used as an effective alternative option in endodontic
treatment of primary teeth. In the present study,
although all three materials have shown clinically as
well as radiographically, comparable and acceptable
190 Journal of Indian Society of Pedodontics and Preventive Dentistry | Volume 37 | Issue 2 | April-June 2019 |
results, yet further studies with a larger sample
size with a longer period of follow‑up is required.
Investigations are also required to understand the
reaction of periapical tissues to drugs as well as the
amount of drug absorption into the systemic circulation.
Ultrastructural, histological and microleakage studies
may be helpful to further determine the suitability of
3Mix‑MP Paste and CTZ Paste in future LSTR studies.
Conclusion
Within the limits of the present in vivo study, we
conclude that all three LSTR techniques used in
respective groups can be used effectively as alternative
to pulpectomy in primary teeth. It can also concluded
that modified 3Mix‑MP antibiotic with and without
removal of radicular pulp treatment and CTZ paste
treatment can be a substitute of pulpectomy procedure
in primary molars requiring pulpectomy.
Acknowledgement
I would like to express my appreciation to the
Department of Pedodontics and Preventive dentistry
staff and junior residents and Department of Plastic
Surgery staff. Without their valuable assistance, this
work would not have been complete.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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requiring pulpectiomy: An in vivo study

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Journal of Indian Society of Pedodontics and Preventive Dentistry | Volume 37 | Issue 2 | April-June 2019 | 191