Effect of Platelet-rich Factor on Implant Stability and Bone Resorption in the Lower Posterior Mandible

Phase 2

• Conditions: Osseointegrated Dental Implantation
• Interventions: Biological: PRF

• Registration Number: NCT02349620
• Lead Sponsor: Reza Tabrizi

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-05
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-23
• Last Update Submitted: 2015-01-23
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29
• Primary Completion: 2015-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients who have 1 or 2 missing teeth in both side of posterior mandible

  • adequate bone quantity and quality at the implant site
  • the implant sites with at least 3 months of healing after extraction,
  • patients well motivated for implant therapy and maintaining good oral hygiene
  • the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm.
  • Patients who gave written informed consent

Exclusion Criteria

• • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome

  • infection around the implant site
  • history of bruxism/parafunctional habits
  • patients with history of any bleeding disorder or on anti-coagulant therapy.
  • pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A:partialy edutolus patients	PRF	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)

Primary Outcome Measures

Name	Time	Method
implant loss	6 months	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

Secondary Outcome Measures

Name	Time	Method
ISQ analysis	3 months	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
bone height (mm)	6 months	Since the implant insertion , bone height was measured in mesial and distal side on standardized IOPA x-ray

Trial Locations

Locations (1)

Shiraz university of medical sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of