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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autogenous Tooth Bone Graft, Immediate Implant Placement, Simvastatin

Intervention / Treatment
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* Procedure: immediate implant placement with ATBG and SMV
* Procedure: immediate implant placement with ATBG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |