The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation

Not Applicable

Completed

• Conditions: Simvastatin; Immediate Implant; Ridge Splitting
• Interventions: Procedure: Immediate implant placement and ARS with GBR; Procedure: Immediate implant placement and ARS with GBR and SMV

• Registration Number: NCT05020405
• Lead Sponsor: Kafrelsheikh University

Brief Summary

Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Primary Completion: 2022-02-12
• Study Completion: 2022-02-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• good general health at the time of surgery.
• at least 3 months of healing after tooth extraction.
• horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

Exclusion Criteria

• a vertical bone defect in the edentulous ridge.
• thick cortex in the labial/buccal with less cancellous bone inside
• obvious undercut on the labial/buccal side.
• uncontrolled periodontal conditions or other oral disorders.
• history of radiotherapy in the head and neck region.
• uncontrolled diabetes mellitus or other systematic disorders.
• smokers.
• Pregnancy.
• non-compliant patients.
• allergic reaction to the medications used.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alveolar ridge splitting with GBR	Immediate implant placement and ARS with GBR	alveolar ridge splitting in combination with the use of GBR without SMV with immediate implant placement
ARS with GBR and SMV	Immediate implant placement and ARS with GBR and SMV	alveolar ridge splitting in combination with the use of GBR with SMV with immediate implant placement

Primary Outcome Measures

Name	Time	Method
Measurements of the amount of bone formation in millimeters around immediately placed dental implants	9 months	Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of SMV in the ridge splitting following immediate implant placement.

Trial Locations

Locations (1)

Faculty of Dentistry, Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Egypt