Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes

Sponsor

British University In Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT06016218

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.

This will be done through:

Measuring bone changes around the implant by cone beam
Measuring change in bone density around the implants

B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Extending to Pulp Dental Implant Failed	Drug: Simvastatin	Phase 1/Phase 2

Detailed Description

Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes

Actual Study Start Date :

Jan 5, 2021

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Feb 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: PRF PRF alone was added to extraction site prior to implant insertion	Drug: Simvastatin Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
Active Comparator: SIM+ PRF PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion	Drug: Simvastatin Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
Active Comparator: BO+ PRF PRF + Bone powder are inserted into the extraction site before implant insertion.	Drug: Simvastatin Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

Arm

Intervention/Treatment

Placebo Comparator: PRF

PRF alone was added to extraction site prior to implant insertion

Drug: Simvastatin

Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

Active Comparator: SIM+ PRF

PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion

Drug: Simvastatin

Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

Active Comparator: BO+ PRF

PRF + Bone powder are inserted into the extraction site before implant insertion.

Drug: Simvastatin

Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

Outcome Measures

Primary Outcome Measures

Changes in crestal peri-imlant Bone [12 months]
Radiographic evaluation of crestal bone changes around the studied implants

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Badly Broken Down Tooth requiring extraction
Medically Free
Any other procedures or surgeries were performed 6 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 like psychologically unstable patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The British University in Egypt	Cairo		Egypt

Sponsors and Collaborators

British University In Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

British University In Egypt

ClinicalTrials.gov Identifier:

NCT06016218

Other Study ID Numbers:

260981

First Posted:

Aug 29, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dental Caries

Simvastatin

Study Results

No Results Posted as of Sep 6, 2023