A Phase 2 interventional study of PRF in Osseointegrated Dental Implantation, sponsored by Reza Tabrizi. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-01-29.
Sponsored by Reza Tabrizi · Phase 2, Interventional, and Treatment
The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.
Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial \& distal side on standardized IOPA x-rays.
This is the only study on the registry with Reza Tabrizi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
patients who have 1 or 2 missing teeth in both side of posterior mandible
Exclusion Criteria:
medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome
In this group surface treated implant with PRF will be inserted.Immediately after the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequency analysis (RFA), using the smart peg type 1, then stability will be measured every 2 weeks up to 3 months .Bone height will be measured in mesial and distal side immediately after placement and in months 3 and 6 with Intra Oral Peri Apical xray (IOPA x-ray)
Biological: PRF
In this group implant with out PRF will be inserted.Immediately after the surgery the implant stability will be measured with the Osstell mentor to verify the resonance frequence analysis (RFA ), using the smartpeg type 1, then stability will be measured every 2 weeks up to 3 months. Bone height was measured in mesial and distal side immediately after placement and in months 3 and 6 with IOPA xray
implant stability was measured by RFA and implant resorption was measured by IOPA after surface treatment by PRF
implant loss
During the osseointegration, if the implant lose his stability and if the patient have pain, the implant will be removed and the implant will be considered lost
Time frame: 6 months
ISQ analysis
Since the implant installation, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure
Time frame: 3 months
bone height (mm)
Since the implant insertion , bone height was measured in mesial and distal side on standardized IOPA x-ray
Time frame: 6 months
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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