Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis

Phase 2Not Yet RecruitingNCT07475364

University of Faisalabad180 enrolled

Overview

The goal of this clinical trial is to compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients. The main questions it aims to answer are: * Is LSTR antibiotic paste (CTZ paste) effective in treating primary molars with pulp necrosis? * Is ZOE pulpectomy effective in treating primary molars with pulp necrosis, and how does its efficacy compare with LSTR therapy? Researchers will compare LSTR therapy (Group A) with ZOE pulpectomy (Group B) to determine which treatment provides better clinical and radiographic outcomes after six months. Participants will: * Be randomly assigned to one of the two treatment groups after diagnosis of pulp necrosis in primary molars. * Receive treatment under standard behavior management techniques with local anesthesia following topical application of 2% lignocaine gel and rubber dam isolation. * Undergo either Lesion Sterilization and Tissue Repair (LSTR) therapy with CTZ paste or zinc oxide eugenol (ZOE) pulpectomy according to group allocation. * Return for a clinical and radiographic follow-up evaluation after six months to assess treatment outcomes. * Allow researchers to record their clinical findings and radiographic results to evaluate the efficacy of both treatment methods.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Pulp Necrosis

Interventions

Group A - LSTR Therapy (CTZ Paste)DRUG

Placement of CTZ antibiotic paste (chloramphenicol, tetracycline, zinc oxide mixed with eugenol) in the pulp chamber after irrigation with 3% sodium hypochlorite, followed by restoration with resin-modified glass ionomer cement.

Group B - ZOE PulpectomyPROCEDURE

Intervention: Conventional pulpectomy including working length determination, canal debridement with K-files and 3% sodium hypochlorite irrigation, followed by obturation with zinc oxide eugenol paste and final restoration with resin-modified glass ionomer cement.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * • Children of both genders * 4 years and 10 years * Pulp necrosis in mandibular primary molars with minimum of 2/3 of the roots * Consent from Parents/Guardian of children. * Sufficient crown structure for restoration Exclusion Criteria: * • Children who have a physical or mental change. * Involving systemic illnesses. * History of allergy to drugs being utilized * Antibiotics use within three months * Teeth with aberrant root resorption or pulp canal obliteration on periapical radiography

Outcomes

Primary Outcomes

Number of Participants with Clinical Success

Clinical success will be assessed based on the absence of sinus tract, soft tissue swelling, or edema associated with the treated primary molar during follow-up clinical examination.

Time frame: 6 months

Number of Participants with Radiographic Success

Radiographic success will be assessed by reduction or complete disappearance of the initial periapical radiolucency and absence of any newly developed radiolucency on follow-up periapical radiographs of the treated tooth.

Time frame: 6 months after treatment

Secondary Outcomes

Reduction in Periapical Radiolucency

Change in the size of periapical radiolucency from baseline to follow-up radiographs in treated primary molars.

Time frame: baseline and 6 months