Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites

Not Applicable

Completed

• Conditions: Simvastatin; Autogenous Tooth Bone Graft; Immediate Implant Placement
• Interventions: Procedure: immediate implant placement with ATBG; Procedure: immediate implant placement with ATBG and SMV

• Registration Number: NCT04992416
• Lead Sponsor: Kafrelsheikh University

Brief Summary

Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic differentiation in bone tissue and promotes osseointegration around implants in animal studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the osseointegration of implants. The present study will be carried out to evaluate the effect of SMV combined with ATG on bone formation around immediately placed dental implants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-01
• Study First Posted: 2021-08-05
• Study Start: 2021-09-02
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
• the teeth without acute inflammation.
• no uncontrolled systemic disease which is not suitable for implantation.
• Good systemic and oral health.

Exclusion Criteria

• patients with systemic diseases or medications known to alter healing processes.
• Psychiatric disorders.
• Root canal treated teeth.
• patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
• patients with para-functional habits.
• alcoholics.
• drug abusers.
• heavy smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATBG around implant	immediate implant placement with ATBG	ATBG around immediately placed dental implants in the extraction sockets
SMV with ATBG around implant	immediate implant placement with ATBG and SMV	SMV mixed with ATBG around immediately placed dental implants in the extraction sockets

Primary Outcome Measures

Name	Time	Method
clinical evaluation of bone formation around immediately placed dental implants	9 months	Changes on bone formation using ATBG with or without SMV around immediately placed dental implants in periodontally compromised teeth
radiographic outcome around immediately placed dental implants	9 months	the radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth

Trial Locations

Locations (1)

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