Triple antibiotic paste versus simvastatin for cleaning and healing infected baby molars
Triple Antibiotic Paste Versus Simvastatin for LSTR Treatment of Primary Molars With Pulp Necrosis: A Randomized Controlled Trial
This trial will test whether a simvastatin paste works as well as a triple antibiotic paste to clean and help heal non-vital primary molars in children aged 5–8.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 8 Years |
| Sex | All |
| Sponsor | Dow University of Health Sciences Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07264842 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 5–8 with restorable non-vital primary molars showing signs such as spontaneous pain, deep caries reaching the pulp, chronic abscess, or a draining sinus are ideal candidates.
Not a fit: Children who are uncooperative, allergic to antibiotics, or whose teeth have advanced physiological root resorption, severe internal resorption, canal obliteration, or other exclusions are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, simvastatin could provide an effective, antibiotic-sparing option to promote healing of infected primary molars.
How similar studies have performed: LSTR using triple antibiotic paste has clinical precedent, while the use of simvastatin in this setting is relatively novel with limited clinical data so far.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Karachi, Sindh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.