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

Immediate Implant Clinical Trial

Official title:

The Effect of Simvastatin With Guided Bone Regeneration on Ridge Volume in Ridge Splitting and Simultaneously Implantation: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020405
• Other study ID #: KFSIRB200- 22
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: February 20, 2022

Study information

• Verified date: July 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 20, 2022
• Est. primary completion date: February 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Implant
• Ridge Splitting

Intervention

Procedure:
• Immediate implant placement and ARS with GBR and SMV
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV
• Immediate implant placement and ARS with GBR
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Kafrelsheikh University	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of the amount of bone formation in millimeters around immediately placed dental implants	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.	9 months