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

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.

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Key information

Conditions

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

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

Number of Participants with Clinical Success

Time frame: 6 months

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.
Number of Participants with Radiographic Success

Time frame: 6 months after treatment

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.

Secondary outcomes

Reduction in Periapical Radiolucency

Time frame: baseline and 6 months

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

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Acronym: LSTR

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 16, 2026
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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