Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group A - LSTR Therapy (CTZ Paste), Group B - ZOE Pulpectomy.
- Who it may be relevant to
- Registry conditions: Pulp Necrosis. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Number of Participants with Clinical Success [Time frame: 6 months]
- Number of Participants with Radiographic Success [Time frame: 6 months after treatment]
Secondary outcome measures (1)
- Reduction in Periapical Radiolucency [Time frame: baseline and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07475364 · TUF/IRB/30/2025