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

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 Overview

• Status: Not yet recruiting
• Conditions: Pulp Necrosis
• Intervention / Treatment: Drug: Group A - LSTR Therapy (CTZ Paste); Procedure: Group B - ZOE Pulpectomy

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LSTR therapy; Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation.	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.
Active Comparator: Zinc Oxide Eugenol (ZOE) Pulpectomy; Participants in this group receive conventional pulpectomy with ZOE paste placed in the root canals.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Periapical Radiolucency	Change in the size of periapical radiolucency from baseline to follow-up radiographs in treated primary molars.	baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Faisalabad

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: primary molars; pulp therapy; LSTR therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathological Conditions, Signs and Symptoms; Dental Pulp Necrosis
• Other Study ID Numbers: TUF/IRB/30/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No