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

Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Simvastatin; Immediate Implant Placement; Autogenous Tooth Bone Graft
• Intervention / Treatment: Procedure: immediate implant placement with ATBG and SMV; Procedure: immediate implant placement with ATBG

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ATBG around implant; ATBG around immediately placed dental implants in the extraction sockets	Procedure: immediate implant placement with ATBG; immediate implant placement using ATBG as a graft material without SMV
Experimental: SMV with ATBG around implant; SMV mixed with ATBG around immediately placed dental implants in the extraction sockets	Procedure: immediate implant placement with ATBG and SMV; immediate implant placement using ATBG as a graft material, with SMV

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: August 1, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KFSIRB200-27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No