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Recruiting NCT07264842

Triple Antibiotic Paste vs Simvastatin for Lesion Sterilization and Tissue Repair in Primary Molars.

Phase II Interventional Pulpal 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: Lesion Sterilization and Tissue Repair using Simvastatin., Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste..
Who it may be relevant to
Registry conditions: Pulpal Necrosis. Basic parameters: 5 years — 8 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
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Triple Antibiotic Paste Versus Simvastatin for LSTR Treatment of Primary Molars With Pulp Necrosis: A Randomized Controlled Trial

Overview

This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis. A total of 60 children (aged 5-8 years) with non-vital primary molars will be recruited from the Department of Operative Dentistry and Endodontics, Dow International Dental College, Karachi. Participants will be randomly assigned to one of two groups: Group 1 (Control): LSTR using Triple Antibiotic Paste (Ciprofloxacin + Metronidazole + Cefixime). Group 2 (Intervention): LSTR using Simvastatin paste. Both materials will be placed after non-instrumentation cleaning and sealed with glass ionomer cement, followed by stainless steel crown placement. Patients will be evaluated clinically and radiographically at 1, 2, and 3 months post-treatment. Primary outcomes include clinical success (absence of pain, swelling, or sinus tract) and radiographic success (reduction or absence of periapical radiolucency). Data will be analyzed using SPSS v26, with chi-square and t-tests applied as appropriate; p \< 0.05 will be considered significant. This study seeks to determine whether Simvastatin, owing to its antibacterial, anti-inflammatory, and regenerative properties, can serve as a viable alternative to antibiotic-based LSTR in managing necrotic primary teeth.

Interventions

  • Combination product Lesion Sterilization and Tissue Repair using Simvastatin.
    Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with simvastatin followed by sealed with the restoration.
  • Combination product Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.
    Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste followed by sealed with the restoration.

Primary outcome measures

  • Clinical Success [Time frame: 1 month, 2 month and 3 month.]
  • Radiographic success [Time frame: 1 month, 2 month and 3 month]

Eligibility criteria

Inclusion criteria

  • Young, healthy patient, ranging in age from 5-8 years.
  • Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
  • Having maxillary and mandibular primary molars with:
  • Spontaneous pain or tenderness to percussion.
  • Deep cavity extending to the pulp chamber.
  • Chronic Abscess or draining sinus.
  • Restorable.
  • To be kept for less than a year.
  • Irregular mobility that is not related to exfoliation.

Exclusion criteria

  • Uncooperative patients.
  • Children with a history of allergic reaction with antibiotics.
  • Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal calcifications, or piercing into the bifurcation.

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
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Dow International Dental College, Chanesar goth. — Karachi

Identifiers

NCT: NCT07264842 · 3379/DUHS//Approval/2024/175

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗