An Invivo Study to Compare the Stability of Dental Implants With or Without Platelet Rich Fibrin Application

Dental Implant Clinical Trial

Official title:

The Effect Of Platelet Rich Fibrin on Implant Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190409
• Other study ID #: D-KA11/06
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: July 14, 2014
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF application on implant osseointegration in the early phase of healing.

Description:

Objectives:Achieving accelerated implant osseointegration could provide immediate or early loading of implants. Platelet-rich fibrin (PRF) is widely used to accelerate soft and hard tissue healing. Activated platelets in PRF release growth factors resulting in cellular proliferation, collagen synthesis and osteoid production. The aim of this study was to compare the stability of dental implants inserted with one-stage surgical protocol with or without PRF application.

Design: Non-randomized, Active Controlled Trial. Material and Methods: Twenty healthy patients (n=10 test group, n= control group) with adequate alveolar bone, having 2 or more adjacent missing teeth, extracted at least 6 months ago were included in this study. Minimum two tapered implants (Ankylosis, DentsplyFriadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket. Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.

Key Words: Dental implant stability, Platelet Rich Fibrin, Resonance frequency analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• The absence of any lesions in the oral cavity, and sufficient residual bone volume to receive two or more adjacent implants of =3.5 mm in diameter and 11.0 mm in length, and extracted at least 6 months ago.

Exclusion Criteria:

• Insufficient bone volume

• Parafunctional habits

• Smoking more than 10 cigarettes per day

• Excessive consumption of alcohol

• Localized radiotherapy of the oral cavity

• Antitumor chemotherapy

• Liver, blood, and kidney diseases

• Immunosuppression

• Current corticosteroid or bisphosphonate use

• Pregnancy

• Mucocutaneous diseases involving oral cavity

• Poor oral hygiene

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dental Implant

Intervention

Device:
• Dental implant
This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 4 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach

Locations

Country	Name	City	State
Turkey	NECMETTIN ERBAKAN University Faculty of Dentistry, Department of Periodontology,	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
ELIF ONCU	Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period.	The stability of the implants were evaluated with the resonance frequency analysis (RFA) method. The measurements were carried out with Osstell ISQ (Implant Stability Quotient) (Osstell, Göteborg, Sweden) by connecting the transducer (smartpeg) to the implant. Two mesio-distal and bucco-lingual measurements were recorded and mean ISQ values were calculated. The resonance frequency measurements were repeated at first and fourth weeks.	Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.	Yes
Secondary	Evaluation of osseointegration in different types of bone	Evaluation early bone healing and compare stability of different bone type (based on the bone quality determined by the insertion torque value)	Resonance frequency measurements in different bone types were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.	Yes