Triple antibiotic paste versus simvastatin for cleaning and healing infected baby molars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blinded, parallel-controlled Phase 2 trial enrolling 60 children with non-vital primary molars to compare lesion sterilization and tissue repair (LSTR) using either triple antibiotic paste (ciprofloxacin + metronidazole + cefixime) or simvastatin paste. After non-instrumentation cleaning, the allocated medicament will be placed, the tooth sealed with glass ionomer cement, and a stainless steel crown fitted. Clinical and radiographic outcomes will be recorded at 1, 2, and 3 months, with primary endpoints including absence of pain, swelling, or sinus tract and radiographic signs of healing. The trial is conducted at Dow International Dental College, Karachi, and aims to offer an antibiotic-sparing alternative if simvastatin proves effective.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dow International Dental College, Chanesar goth.
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Study coordinator: Muhammad Waleed Postgraduate Trainee, FCPS
• Email: waleedmumtaz.401194@duhs.edu.pk
• Phone: 923222046451

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.