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

Indication
Dental Caries