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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05008068
Other study ID # 0012490
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 12, 2019
Est. completion date September 12, 2020

Study information

Verified date August 2021
Source British University In Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants. PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation. MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 12, 2020
Est. primary completion date September 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria: - patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses, - any extractions, or surgeries performed at least six months earlier. Exclusion Criteria: - patients with systemic diseases affecting bone quality or resorption - temporomandibular joint dysfunction, - severe attrition or parafunctional habits, - patients undergoing radiotherapy or chemotherapy, - heavy smokers, - vulnerable groups such as psychologically unstable patients

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Simvastatin
Simvastatin with PRF at site of osteotome

Locations

Country Name City State
Egypt The British University in EGYPT Cairo

Sponsors (1)

Lead Sponsor Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The measurement of bone thickness Measuring unit in millimeters , measuring device is CBCT software After 3 months of the osteotomy and application of Simvastatin
Primary The measurement of bone thickness Measuring unit in millimeters , measuring device is CBCT software After 6 months of the osteotomy and application of Simvastatin
Primary The measurement of bone thickness Measuring unit in millimeters , measuring device is CBCT software After 12 months of the osteotomy and application of Simvastatin
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