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

NCT07475364 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Pulp Necrosis

Interventions

DRUG

Group A - LSTR Therapy (CTZ Paste)

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.

PROCEDURE

Group B - ZOE Pulpectomy

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.

Sponsors & Collaborators

  • University of Faisalabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-01
Completion
2027-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475364 on ClinicalTrials.gov