CMU. J. Nat. Sci. (2013) Vol.

12(2) 131
DOI: 10.12982/CMUJNS.2013.0012

Retrospective Study of Pulpectomy with Vitapex® and LSTR

with Three Antibiotics Combination (3Mix) for
Non-Vital Pulp Treatment in Primary Teeth*

Achiraya Duanduan, Varisara Sirimaharaj* and Papimon Chompu-inwai

Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, Chiang

Mai University, Chiang Mai 50200, Thailand
*Corresponding author. E-mail: vsjaa@yahoo.co.uk

ABSTRACT
Pulpectomy with Vitapex®
and Lesion Sterilization and Tissue Repair
Therapy (LSTR) with 3Mix MP are treatment options for non-vital pulp treat-
ment in primary teeth. The outcomes of both treatments have been reported, but
with limited follow-up periods. Moreover, the factors relevant to their success
have yet to be determined.
The aim of this research was to evaluate the success of non-vital pulp
treatments with Vitapex® pulpectomy and LSTR with 3Mix MP in different
follow-up periods and to determine the factors that influence success of the
treatment. This was a retrospective study of 73 teeth that had non-vital pulp
treatment, either with Vitapex® or 3Mix MP, in healthy children, aged 3-10
years, at the Pediatric Dentistry Clinic, Chiang Mai University, Thailand. The
records included clinical and radiographic examinations at follow-up periods
ranging from 6-72 months. Success rates of both groups and the various factors
that may influence success were determined by descriptive analysis.
Including all follow-up periods (from 6 to 72 months), the average success
rates of the Vitapex® group determined by clinical and radiographic evalua-
tions were 89.0% and 64.6%, respectively. The success rates of the 3Mix MP
group determined by clinical and radiographic evaluations were 84.6% and
65.2%, respectively. The influences of various permanent restorations and the
time elapsed between the temporary and permanent restorations were found to
influence the success of non-vital pulp treatment in primary teeth. Both pulpec-
tomy with Vitapex® and LSTR with 3Mix MP were acceptable treatment options
of non-vital pulp treatment in primary teeth.

Keywords: Vitapex®, 3Mix MP, Non-vital pulp treatment, Primary teeth

INTRODUCTION
Maintenance of primary dentition is imperative for the development of
arch form, esthetics, function, mastication and normal eruption of permanent

*Presented in the 1st ASEAN PLUS THREE Graduate Research Congress (AGRC), March 1-2, 2012, Chiang
Mai, Thailand.
132 CMU. J. Nat. Sci. (2013) Vol. 12(2)

teeth. Premature loss, especially of the primary second molar, can cause various
problems. This usually results in mesial eruption of the first permanent molars and
causes subsequent problems such as ectopic eruption of the second premolar, space
loss for the successor permanent teeth, alterations in speech and impairment of
function (AAPD, 2010-2011). Therefore, decayed primary teeth should be treated
whenever possible. However, infected teeth with gross loss of tooth structure, lack
of adequate bone support, excessive pathologic root resorption, advanced internal
or external resorption, furcation involvement or periapical infection involving the
crypt of the succedaneous tooth should be considered for extraction (Fuk, 2005;
Sari and Okte, 2008; AAPD, 2010-2011).
In non-vital primary teeth for which extraction is not the aim, pulpectomy
is generally recommended as a treatment of choice. The procedure involves
removing coronal and radicular pulp tissues, debridement, enlargement and fill-
ing the root canal with intracanal medicament (AAPD, 2010-2011). The ideal
intracanal medicament for pulpectomy in primary teeth should have the following
properties: easily fill the root canal, be antiseptic, resorb at a similar rate as the
primary root, not harm the periapical tissue and permanent tooth germ, resorb
readily if extruded beyond the apex, adhere to root canal walls, not shrink, be
radiopaque, and not discolor the tooth (Mortazavi and Mesbahi, 2004; Fuk, 2005;
Ozalp et al., 2005). However, while no single material meets all the requirements
of an ideal intracanal medicament for a primary tooth (Mortazavi and Mesbahi,
2004; Fuk, 2005; Ozalp et al., 2005), Vitapex®, a premixed calcium hydroxide
and iodoform paste, comes close. Many authors have reported favorable results
with Vitapex®, with success rates from 96% to 100% (Nurko and Garcia-Godoy,
1999; Mortazavi and Mesbahi, 2004; Ozalp et al., 2005; Nakornchai et al., 2010).
Vitapex® is biocompatible, rapidly resorbs when extruded beyond the apex and is
easily removed if retreatment is needed. However, its rapid resorption may reduce
its antibacterial properties and lower its disinfection properties compared to other
root canal filling materials (Nakornchai et al., 2010).
Lesion Sterilization and Tissue Repair Therapy (LSTR), or Non Instrumental
Endodontic Treatment (NIET), is a new biological approach for non-vital pulp
treatment. This procedure has no mechanical instrumentation; thus, prevents over
enlargement of root canal and unnecessary irritation of periapical tissue (Takushige
et al., 2004; Nakornchai et al., 2010; Handajani et al., 2010). This procedure uses
a mixture of three antibacterial drugs (3Mix MP) as a root canal medicament to
eliminate the remaining bacteria in endodontic lesions. The medicament consists of
metronidazole, ciprofloxacin and minocycline – with macrogol (M) as the ointment
base and propylene glycol (P) as the carrier (Takushige et al., 2004; Handajani
et al., 2010). The short-term success of 3Mix MP in non-vital pulp treatment
in primary teeth has been reported in some studies. Many authors have reported
favorable results of 3Mix MP with success rates from 83% to 100% (Takushige
et al., 2004; Alam et al., 2005; Handajani et al., 2010; Nakornchai et al., 2010).
However, the success of this treatment over longer follow-up periods has not yet
been reported.
 CMU. J. Nat. Sci. (2013) Vol. 12(2) 133

Various factors affect the outcome of non-vital pulp treatment. These factors
consist of diagnosis and pathologic conditions of the tooth prior to the treatment,
types of non-vital pulp treatment and medicaments, irrigants, temporary materials
and permanent restorations (Sjogren et al., 1990). Nevertheless, few have studied
the factors influencing success in primary teeth with non-vital pulp treatment. We,
therefore, were interested in studying the long-term success rate of non-vital pulp
treatment in primary teeth, particularly with Vitapex® and 3Mix MP medicaments.
We also wanted to clarify further the relationship between the above factors and
the success rate of non-vital pulp treatment.

MATERIALS AND METHODS

This study was approved by the Research Ethics Committee of the Faculty
of Dentistry, Chiang Mai University, Thailand. The dental records of patients at
the Pediatric Dentistry Clinic, Faculty of Dentistry, Chiang Mai University that
had non-vital pulp treatments with Vitapex® or 3Mix MP in primary teeth from
January 2005 to May 2011 were used for this study. If the records met the inclu-
sion criteria, the patients were called back for follow-up.
The clinical and radiographic inclusion criteria were: (1) history of non-vital
pulp treatment with Vitapex® or 3Mix MP; (2) absence of a systemic disease; (3)
dental records included adequate information (diagnosis, medicaments, irrigants,
temporary materials and permanent restorations, at the minimum); (4) dental
records had pre-operative and recall radiographs for assessing at least 6 months
of follow-up. The criteria for clinical and radiographic success are shown in
Table 1.

Table 1. The criteria for clinical and radiographic success.

Criteria for success
Clinical success
1. No pain
2. No tenderness to percussion and palpation
3. No gingival swelling, sinus tract or purulent
4. No pathological mobility
Radiographic success
1. No newly formed radiographic pathologic lesions
2. No progression of pathologic external or internal root resorption, furcation involvement
or periapical radiolucency, if any lesions present pre-operatively
3. A reduction in size of furcation involvement or periapical radiolucency, if any lesions
present pre-operatively

Teeth were considered a clinical success if they met all of the clinical
success criteria. Teeth were considered a radiographic success if they met one of
the radiographic success criteria. All teeth were assessed by one examiner. Intra-
examiner reliability of radiographic evaluation was calculated by Cohen’s kappa
statistic, which indicated an acceptable agreement of 0.97.
134 CMU. J. Nat. Sci. (2013) Vol. 12(2)

The demographic data and factors that may affect success rate were
recorded. The follow-up periods were divided into six groups: (1) >6-12 months;
(2) >12-24 months; (3) >24-36 months; (4) >36-48 months; (5) >48-60 months;
(6) >60-72 months. The data obtained was analyzed by descriptive statistics.

RESULTS
A total of 73 primary teeth that had non-vital pulp treatment either by
Vitapex® pulpectomy or 3Mix MP therapy were identified as meeting the study
criteria. Fifty-two healthy children, aged between 3 to 10 years (mean age=4.4
years), participated in this study. Demographic data of the patients is shown
in Table 2. Distribution of teeth according to the follow-up period is shown in
Table 3.

Table 2. Demographic and treatment data of patients.

Characteristics N %
Child’s gender
Male 29 52.4
Female 23 47.6
Type of tooth
Anterior 2 2.7
Maxillary molars 31 42.5
Mandibular molars 40 54.8
Type of medicament
Vitapex® 50 68.5
3Mix MP 23 31.5

Table 3. Number of teeth according to follow-up period.

Groups Follow-up periods (months) Vitapex® (N) 3Mix MP (N)
1 >6-12 42 15
2 >12-24 23 11
3 >24-36 14 13
4 >36-48 13 11
5 >48-60 6 6
6 >60-72 4 4
 CMU. J. Nat. Sci. (2013) Vol. 12(2) 135

Table 4. Success rate of the Vitapex® group according to follow-up period.

Vitapex®
Follow-up periods (months) Clinical success Radiographic success n/N
n/N (%) (%)
>6-12 40/42 (95.24) 35/42 (83.33)
>12-24 22/23 (95.65) 20/23 (86.95)
>24-36 14/14 (100.00) 10/14 (71.43)
>36-48 11/13 (84.61) 6/13 (46.15)
>48-60 5/6 (83.33) 3/6 (50.00)
>60-72 3/4 (75.00) 2/4 (50.00)
Mean 6-72 months (%) 88.97 64.64
Note: N= number of total treated teeth in the Vitapex ® pulpectomy group. n= number of treated
teeth that were determined as success in the Vitapex ® pulpectomy group.

Table 5. Success rate of the 3Mix MP group according to follow-up period.

3Mix MP
Follow-up periods (months) Clinical success Radiographic success n/N
n/N (%) (%)
>6-12 14/15 (93.33) 13/15 (86.66)
>12-24 10/11 (90.90) 8/11 (72.73)
>24-36 13/13 (100.00) 11/13 (84.62)
>36-48 9/11 (81.82) 7/11 (63.64)
>48-60 4/6 (66.67) 2/6 (33.33)
>60-72 3/4 (75.00) 2/4 (50.00)
Mean 6- 72 months (%) 84.62 65.16
Note: N= number of total treated teeth in the LSTR with 3Mix MP group. n= number of treated
teeth that were determined as success in the LSTR with 3Mix MP group.

This study examined the clinical and radiographic success rates of Vitapex ®
and 3Mix MP for non-vital pulp treatment in long-term follow-up and revealed
high clinical success rate and fairly high radiographic success rate of both treat-
ments (Table 4 and 5).
Including all follow-up periods (from 6 to 72 months), the overall success
rates of the Vitapex® group as determined by clinical and radiographic evaluations
were 89.0% and 64.6%, respectively. The success rates of the 3Mix MP group
as determined by clinical and radiographic evaluations were 84.6% and 65.2%,
respectively. No statistically significant difference was found between the two
groups.
We noted some treatment failures from both treatments as detailed in Tables
6 and 7.
136 CMU. J. Nat. Sci. (2013) Vol. 12(2)

Table 6. Failure characteristics of Vitapex® according to groups of follow-up

period.
Vitapex® group
Group of follow-up
period* 1 2 3 4 5 6 Total
Failure findings (N) (N) (N) (N) (N) (N) (N)

Clinical failures
-Pain 1 1 0 2 1 0 5
-Sinus tract/ pus exudate 1 1 0 0 0 0 2
-Abnormal mobility 0 0 0 1 0 0 1
-Gingival swelling 0 0 0 1 1 0 2
-Enamel defect on permanent tooth 0 0 0 0 0 1 1
Radiographic failures
-Furcation involvement 7 1 4 7 3 1 23
-Periapical radiolucency 0 0 0 0 0 0 0
-Pathologic root resorption 0 2 1 0 0 1 4
Note: *Groups of follow-up period (months): 1. >6-12, 2. >12-24, 3. >24-36, 4. >36-48, 5. >48-60,
6. >60-72.

Table 7. Failure characteristics of 3Mix MP according to groups of follow-up

period.
3Mix MP group
Group of follow-up
period* 1 2 3 4 5 6 Total
Failure findings (N) (N) (N) (N) (N) (N) (N)

Clinical failures
-Pain 1 1 0 1 2 0 5
-Sinus tract/ pus exudate 0 1 0 0 0 0 1
-Abnormal mobility 0 0 0 1 0 0 1
-Gingival swelling 0 0 0 1 1 0 2
-Enamel defect on permanent tooth 0 0 0 0 0 1 1
Radiographic failures
-Furcation involvement 1 3 2 2 2 1 11
-Periapical radiolucency 1 0 0 2 2 0 5
-Pathologic root resorption 0 0 0 0 0 0 1
Note: *Groups of follow-up period (months): 1. >6-12, 2. >12-24, 3. >24-36, 4. >36-48, 5. >48-60,
6. >60-72.

DISCUSSION
In the present study, Vitapex®, medicament for pulpectomy procedure,
gave a high clinical success rate at 12-24 months (95.7%) that was close to the
previous prospective studies (Nurko and Garcia-Godoy, 1999; Mortazavi and
Mesbahi, 2004; Ozalp et al., 2005; Trairatvorakul and Chunlasikaiwan, 2008;
Nakornchai et al., 2010) and the retrospective study (Sirimaharaj and Sinsoon-
torn, 2008), which reported clinical success rates of 96-100% at 12-22 months
 CMU. J. Nat. Sci. (2013) Vol. 12(2) 137

of follow-up. Regarding the radiographic success, the pulpectomy with Vitapex ®

group showed a high radiographic success rate at 12-24 months (87.0%). This
was lower than that of Trairatvorakul and Chunlasikaiwan (2008), which showed
radiographic success rate of 89%, as well as the studies of Ozalp et al., (2005)
and Nurko and Garcia-Godoy (1999), which showed radiographic success rate
of 100%. However, the results of this study were higher than that of Nakornchai
et al., (2010), which showed a radiographic success rate of 56% at 12-months
follow-up. The fairly low radiographic success of the latter study may possibly be
due to the sample selection, since only teeth with a poor prognosis were selected
for the study (Nakornchai et al., 2010).
LSTR 3Mix therapy also showed a high clinical success rate at 12-24 months
(90.9%), but lower than the studies of Takushige et al., (2004), Prabhakar et al.,
(2008), and Nakornchai et al., (2010), which reported clinical success rates of
96-100% at follow-up periods from 12-20 months. This present study also found
that clinical success rates of the LSTR 3Mix therapy group tended to decrease in
long-term follow-up, similar to the study of Trairatvorakul and Detsomboonrat
(2011). Regarding the radiographic success, the LSTR 3Mix therapy group showed
a fairly high radiographic success rate at 12-24 months (72.7%) that was lower
than that of Prabhakar et al., (2008) (76.7%) and Nakornchai et al., (2010) (76%)
at the 12-month follow-up period. In the present study, 84.1% of the samples in
the LSTR 3Mix therapy group were teeth with a poor prognosis, similar to those
from Nakornchai et al., (2010). The radiographic success in this present study
was higher than the study of Trairatvorakul and Detsomboonrat (2011), which
reported only 36.7% radiographic success at 24-27 months follow-up. The dif-
ferences in study designs, sample sizes and treatment procedures may influence
these different results.
Nevertheless, failed cases of the Vitapex® and 3Mix MP groups were found,
using both the clinical and radiographic criteria. We found failures in the Vitapex ®
and 3Mix MP groups that presented with the leakage of temporary filling in two
visits-non-vital pulp treated teeth and the deterioration and leakage of permanent
restoration, such as composite resin or glass ionomer cement. These factors can
lead to bacterial penetration (Anderson et al., 1990; Demarco et al., 2005; Qvist
et al., 2010). Thus, the influence of various permanent restorations and the time
elapsed between the temporary and permanent restorations were found to be
relevant to the success of non-vital pulp treatment in primary teeth.
From this study, both pulpectomy with Vitapex ® and LSTR therapy with
3Mix MP showed acceptable success rates. It seems that LSTR therapy with
3Mix MP may be appropriate for treatment of poor prognosis cases or cases for
which mechanical instrumentation could not be achieved due to physiologic root
resorption (Takushige et al., 2008).

ACKNOWLEDGEMENTS
This research was supported by the Faculty of Dentistry and the Graduate
School, Chiang Mai University.
138 CMU. J. Nat. Sci. (2013) Vol. 12(2)

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