Clinical trial
Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
Name
260981
Description
This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.
This will be done through:
1. Measuring bone changes around the implant by cone beam
2. Measuring change in bone density around the implants
B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.
Trial arms
Trial start
2021-01-05
Estimated PCD
2022-01-05
Trial end
2023-02-05
Status
Completed
Phase
Early phase I
Treatment
Simvastatin
Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
Arms:
BO+ PRF, PRF, SIM+ PRF
Size
24
Primary endpoint
Changes in crestal peri-imlant Bone
12 months
Eligibility criteria
Inclusion Criteria:
* Badly Broken Down Tooth requiring extraction
* Medically Free
* Any other procedures or surgeries were performed 6 months earlier
Exclusion Criteria:
* patients with systemic diseases affecting bone quality or resorption
* temporomandibular joint dysfunction
* severe attrition or parafunctional habits
* patients undergoing radiotherapy or chemotherapy
* heavy smokers
* vulnerable groups like psychologically unstable patients.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2023-09-06
1 organization
1 product
2 indications
Organization
British University in EgyptProduct
SimvastatinIndication
Dental CariesIndication
Dental Implant Failure