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

NCT ID: NCT02349620

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Osseointegrated Dental Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A:partialy edutolus patients

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)

Group Type ACTIVE_COMPARATOR

PRF

Intervention Type BIOLOGICAL

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

B: partialy edutolus patients

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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PRF

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reza Tabrizi

OTHER

Sponsor Role lead

Responsible Party

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Reza Tabrizi

Assistant professor of shahid beheshti university of medical sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Reza Tabrizi, DMD

Role: STUDY_CHAIR

Shiraz University of Medical Sciences

Touba karagah, DMD

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

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Shiraz university of medical sciences

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Reza Tabrizi, DMD

Role: CONTACT

09125850829

Facility Contacts

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Reza Tabrizi, DMD

Role: primary

989125850829

Other Identifiers

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123456

Identifier Type: -

Identifier Source: org_study_id

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