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

NCT07475364 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: TUF/IRB/30/2025
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

LSTR therapy; primary molars; pulp therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months after treatment

Secondary Outcomes (1)

• Reduction in Periapical Radiolucency

  baseline and 6 months

Study Arms (2)

LSTR therapy

EXPERIMENTAL

Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation.

Drug: Group A - LSTR Therapy (CTZ Paste)

Zinc Oxide Eugenol (ZOE) Pulpectomy

ACTIVE COMPARATOR

Participants in this group receive conventional pulpectomy with ZOE paste placed in the root canals.

Procedure: Group B - ZOE Pulpectomy

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.

LSTR therapy

Group B - ZOE Pulpectomy PROCEDURE

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.

Zinc Oxide Eugenol (ZOE) Pulpectomy

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of both genders
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03