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

University of Faisalabad

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Pulp Necrosis

Treatments: Procedure: Group B - ZOE Pulpectomy; Drug: Group A - LSTR Therapy (CTZ Paste)

Study type: Interventional

Funder types: Other

Identifiers

NCT07475364

TUF/IRB/30/2025

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

LSTR therapy

Experimental group

Description:

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

Treatment:

Drug: Group A - LSTR Therapy (CTZ Paste)

Zinc Oxide Eugenol (ZOE) Pulpectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Group B - ZOE Pulpectomy