Analysis of Simvastatin (anti-cholesterol drug) gel in bone formation.

Phase 2/3

Completed

• Conditions: Impacted teeth, (2) ICD-10 Condition: K011||Impacted teeth,

• Registration Number: CTRI/2022/09/046022
• Lead Sponsor: Dr Monika Gupta

Brief Summary

This is a randomized controlled trial (flip of coin), interventional split mouth study to compare the quality and quantity of osseous regenerate in the bony surgical extraction sockets of bilaterally impacted third molars, using Simvastatin Semi-solid gel formulation versus PRF. The primary objective of the study is to determine bone mineral density, bone volume, bone height and trabecular pattern of regenerate, via CBCT analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Study Completion: 2022-01-12
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Surgical site should be free of infection.
• Patient requiring extraction bilaterally of impacted mandibular third molars.
• The site should be where primary wound closure can be achieved.

Exclusion Criteria

• Patient having connective tissue/bleeding disorders.
• Patient who have undergone radiation/chemotherapy to head and neck region.
• Patients allergic to drug simvastatin.
• Patient having uncontrolled diseases of systemic nature.
• Patients with fibro-osseous diseases of bone.
• Any pathology associated with apical region of mandibular third molar.
• Patients on immuno-supressants and/or on anticoagulants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the bone height, bone volume, bone mineral density and trabecular pattern in the empty surgical extraction socket where simvastatin/PRF (Platelet Rich Fibrin) is placed, via CBCT analysis.	CBCT analysis to be done- | of bony socket before placement of Simvastatin/PRF immediately after surgical extraction of third molars (baseline). | 6th month post-operatively.

Secondary Outcome Measures

Name	Time	Method
To estimate pain at follow-up.	1st week, 3rd week, 3rd month and at 6th month.
To measure swelling at follow-up.	1st week, 3rd week, 3rd month and at 6th month.
To assess the probing depth distal to the second molar.	1st week, 3rd week, 3rd month and at 6th month.
To observe for trismus.	1st week, 3rd week, 3rd month and at 6th month.

Trial Locations

Locations (1)

Maharishi Markandeshwar College of Dental Sciences and Research; 🇮🇳 Ambala, HARYANA, India

Maharishi Markandeshwar College of Dental Sciences and Research

🇮🇳Ambala, HARYANA, India

Dr Monika Gupta

Principal investigator

09888895374

monikabox@yahoo.com