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

July 17, 2023 updated by: Dalia Rasheed Issa, Kafrelsheikh University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafr Ash Shaykh, Egypt, 33511
        • faculty of dentistry, kafrelsheikh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARS with GBR and SMV
alveolar ridge splitting in combination with the use of GBR with SMV with immediate implant placement
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
Active Comparator: alveolar ridge splitting with GBR
alveolar ridge splitting in combination with the use of GBR without SMV with immediate implant placement
Procedure: Immediate implant placement and ARS with GBR
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of the amount of bone formation in millimeters around immediately placed dental implants
Time Frame: 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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Investigators

  • Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

February 12, 2022

Study Completion (Actual)

February 20, 2022

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • KFSIRB200- 22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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