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

NCT02349620 | Unknown Phase 2 DMC

• 1 other identifier: 123456
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osseointegrated Dental Implantation

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (2)

• ISQ analysis

  3 months

• bone height (mm)

  6 months

Study Arms (2)

A:partialy edutolus patients

ACTIVE COMPARATOR

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

B: partialy edutolus patients

PLACEBO COMPARATOR

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

Interventions

PRF BIOLOGICAL

implant stability was measured by RFA and implant resorption was measured by IOPA after surface treatment by PRF

A:partialy edutolus patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reza Tabrizi: lead

Study Sites (1)

Shiraz university of medical sciences

Shiraz, Fars, Iran

RECRUITING

Study Officials

• Reza Tabrizi, DMD

  Shiraz University of Medical Sciences

  STUDY CHAIR

• Touba karagah, DMD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Tabrizi, DMD

CONTACT

09125850829; Tabmed@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of shahid beheshti university of medical sciences

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: January 29, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

IR (1)