Comparative evaluation of clinical and radiographic success of lesion sterilization tissue repair (LSTR), modified LSTR with triple antibiotic paste and metapex pulpectomy in primary molars: a randomized controlled clinical study

INTRODUCTION 

Paediatric dentists come across with a number of cases with deep caries that has reached the periradicular tissues. Traditional treatment options for such teeth include extraction and conventional endodontic procedure i.e., pulpectomy. Although, extraction followed by placement of a space maintainer is a treatment option, preserving natural teeth in the arch is the better option. Successfully treated primary tooth is a superior space maintainer than an appliance. . To preserve pulpally involved primary tooth in the arch two techniques are indicated, conventional endodontic treatment i.e., pulpectomy and lesion sterilsation tissue repair (LSTR).

Pulpectomy has high success rate and can be used for the treatment of non vital tooth (abscessed, dead or dying) with no evidence of root resorption. According to AAPD guidelines pulpectomy is preferred over LSTR in tooth with no root resorption. LSTR is preferred over pulpectomy in teeth with root resorption. There are some recent researches which comparing the success of LSTR with pulpectomy irrespective of root resorption. These studies concluded that LSTR is better than pulpectomy. Removal of radicular pulp along with coronal pulp in LSTR procedure has better result than LSTR with removal of only coronal pulp.

Therefore, this study has been designed to compare the clinical and radiographic success of LSTR, modified LSTR and pulpectomy.

Aim:

To find out best among the three techniques (LSTR, modified LSTR and pulpectomy)

METHODOLOGY:

Study Design: The present study will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, KGMU, Lucknow. The study will be started only after the ethical approval by the Institutional Ethical Committee of King George’s Medical University, Lucknow.

Study Participants:

Patients within the age group 3 to 10 years, irrespective of gender and socioeconomic status will be enrolled in the study.

Inclusion criteria:

Non vital primary posterior teeth

Teeth with 1/3rd or <2/3 rd root resorption

Presence or absence of  furcal radiolucency

Severe bone loss and mobility

Parents not willing to extraction

Exclusion criteria:

Allergic to any contents of triple antibiotic paste

Radiographic evidence of excessive external and internal resorption

Primary teeth nearing exfoliation

Non restorable tooth

SAMPLE SIZE CALCULATION

Sample size estimation was done by using G Power software (version 3.0).  Sample size was estimated for Chi square test and Goodness of fit tests: Contingency tables was chosen.

A minimum total sample size of 61 was found to be sufficient for an alpha of 0.05, power of 80%, 0.4 as effect size (anticipated moderate effect size) and 2 as degrees of freedom.

This sample size is rounded off to 63 (21 per group).

Procedure:

Informed consent will be obtained from parents. All participants will be screened by taking detailed history and performing thorough clinical and radiographic examination. Based on the inclusion and exclusion criteria, all selected primary teeth shall be randomly divided into three groups depending on the type of technique used.

Group I: Pulpectomy with metapex

Group II: Only the coronal pulp will be removed and the pulp chamber half filled with modified 3Mix antibiotic paste, sealed with glass ionomer cement (GIC) and reinforced with stainless crown.

Group III: Both coronal as well as all accessible radicular pulp tissue will be extirpated and the medication cavity half�’filled with modified 3Mix antibiotic paste, sealed with GIC and reinforced with stainless crown.

Isolation of the operating field with rubber dam will be done. Radiographic and clinical evaluation will be done at 3 month intervals for at least a 12 month period.

Evaluation of outcome:

Clinical evaluation:

Resolution or improvement of clinical symptoms will be checked after treatment. Clinical success will be considered in the absence of pain, swelling, sinus tract or natural exfoliation of teeth.

Radiographic evaluation

Radiographic success will include absence, decrease or disappearance of initial radiolucent area, and no new radiolucency.

Ø  Data collection method

The data for each tooth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to to statistical analysis.

Statistical analysis:

Data will be analysed using Statistical Package for Social Sciences (SPSS) version 21. As outcome measures are categorical in nature, thus, will be summarized as absolute and relative frequencies. The intergroup comparison of outcome measures will be done using chi square test. The level of statistical significance will be set at 0.05.