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

Reza Tabrizi

Status and phase: Unknown; Phase 2

Conditions: Osseointegrated Dental Implantation

Treatments: Biological: PRF

Study type: Interventional

Funder types: Other

Identifiers

NCT02349620

123456

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

A:partialy edutolus patients

Active Comparator group

Description:

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)

Treatment:

Biological: PRF

B: partialy edutolus patients

Placebo Comparator group

Description:

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