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

Sponsor

Kafrelsheikh University (Other)

Overall Status

Completed

CT.gov ID

NCT05020405

Collaborator

(none)

Enrollment

Location

Arms

16.7

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ridge Splitting Simvastatin Immediate Implant	Procedure: Immediate implant placement and ARS with GBR and SMV Procedure: Immediate implant placement and ARS with GBR	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Feb 12, 2022

Actual Study Completion Date :

Feb 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Kafrelsheikh University	Kafr Ash Shaykh		Egypt	33511

Sponsors and Collaborators

Kafrelsheikh University

Investigators

Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dalia Rasheed Issa, principle investigator, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT05020405

Other Study ID Numbers:

KD/22/20

First Posted:

Aug 25, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Apr 1, 2022

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

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

Study Results

No Results Posted as of Apr 4, 2022