Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kafrelsheikh University
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- clinical evaluation of bone formation around immediately placed dental implants
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
clinical evaluation of bone formation around immediately placed dental implants
Time Frame: 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
Time Frame: 9 months
the radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth
Secondary Outcomes
No secondary outcomes reported
Investigators
Dalia Rasheed Issa
Principle investigator
Kafrelsheikh University