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NCT Number: NCT07264842

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

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.

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Key information

Conditions

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

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dow International Dental College, Chanesar goth.

Karachi, Sindh, 75950, Pakistan

Location status: Recruiting

Location contact

Muahammad Waleed Mumtaz, BDS

PRINCIPAL_INVESTIGATOR

Muhammad Waleed Postgraduate Trainee - FCPS, BDS

CONTACT

[email protected]

923222046451

Prof.Dr. Farah Naz Supervisor, FCPS

CONTACT

[email protected]

03002345434

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lesion Sterilization and Tissue Repair using Simvastatin.

Combination Product

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.

Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.

Combination Product

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 outcomes

  1. Clinical Success

    Time frame: 1 month, 2 month and 3 month.

    Change in pain through visual analog scale and size of swelling in millimeters will be assessed to measure clinical success.

  2. Radiographic success

    Time frame: 1 month, 2 month and 3 month

    Change in radiolucency through the periapical index will be measured to assess radiographic success.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Waleed Postgraduate Trainee, FCPS

CONTACT

[email protected]

923222046451

Prof. Dr. Farah Naz Supervisor, FCPS

CONTACT

[email protected]

03002345434

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Acronym: LSTR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Mar 10, 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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