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

Dow University of Health Sciences

Status and phase: Enrolling; Phase 2

Conditions: Pulpal Necrosis

Treatments: Combination Product: Lesion Sterilization and Tissue Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT07264842

3379/DUHS//Approval/2024/175

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Simvastatin

Experimental group

Description:

Lesion Sterilization and Tissue Repair using Simvastatin.

Treatment:

Combination Product: Lesion Sterilization and Tissue Repair

Triple Antibiotic Paste

Active Comparator group

Description:

Lesion Sterilization and Tissue Repair using triple antibiotic paste

Treatment:

Combination Product: Lesion Sterilization and Tissue Repair