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

Immediate Implant Placement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992416
• Other study ID #: KFSIRB200-27
• Status: Completed
• Phase: N/A
• Start date: September 2, 2021
• Est. completion date: December 15, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 15, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autogenous Tooth Bone Graft
• Immediate Implant Placement

Intervention

Procedure:
• immediate implant placement with ATBG and SMV
immediate implant placement using ATBG as a graft material, with SMV
• immediate implant placement with ATBG
immediate implant placement using ATBG as a graft material without SMV

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	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
Primary	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