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A study to evaluate whether 1.2 percentage Simvastatin gel improves bone healing after lower wisdom tooth removal in patients

Evaluation of the effect of local application of 1.2 percentage Simvastatin gel on bone regeneration following surgical extraction of impacted mandibular third molar- A randomized clinical study - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111734
Enrollment
50
Registered
2026-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K011- Impacted teeth

Interventions

Intervention1: 1.2 % Simvastatin gel: Patients undergoing surgical extraction of impacted mandibular third molars will receive local application of 1.2% simvastatin gel placed in gelfoam within the ex

Sponsors

Dr Karishma Dave
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 40 years Patients requiring surgical extraction of impacted mandibular third molar. Healthy patients classified as ASA I (American Society of Anesthesiologists Physical Status). Patients willing to participate and provide written informed consent. Patients with absence of active infection at the surgical site.

Exclusion criteria

Exclusion criteria: Patients with systemic diseases affecting wound healing or bone metabolism (e.g., diabetes, severe osteoporosis, immunocompromised states). Patients on medications affecting bone metabolism or healing (e.g., corticosteroids, bisphosphonates, immunosuppressants, systemic statins). Patient post major CVS / Cerebrovascular disease. Patient on anticoagulant / antiplatelet therapy. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
The local application of 1.2 % Simvastatin gel following surgical removal of impacted mandibular third molar is expected to result in improved radiographic bone regeneration.Timepoint: Baseline, 1 month, 3 months, 6 months.

Secondary

MeasureTime frame
The local application of 1.2 % Simvastatin gel following surgical removal of impacted mandibular third molar is expected to result in reduced pain and improved periodontal healing.Timepoint: Baseline, 3 day, 7 day, 1 month, 3 months, 6 months.

Countries

India

Contacts

Public ContactDR ABHILASHA YADAV

GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MUMBAI

drabhilasha@yahoo.com9890002523

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026