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

NCT ID: NCT02190409

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-12-31

Brief 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.

Detailed 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

Conditions

Dental Implant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Test, Control

Test: Minimum two tapered implants (Ankylosis, Dentsply Friadent) 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 Control: Other socket was selected as a control group (No Platelet Rich Fibrin used): In the control group no extra intervention used and the conventional procedure was done. Thus the readings of the experimental arm compared with this control.

Group Type: EXPERIMENTAL

Dental implant

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

The implant in this protocol; 3.5 mm width and 11 mm length) ANKYLOS C/X dental implants were used (Dentsply, Hanau, Germany

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baskent University

OTHER

Sponsor Role: collaborator

ELİF ONCU

OTHER

Sponsor Role: lead

Responsible Party

ELİF ONCU

Assist.Prof.Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ELİF ÖNCÜ, 1

Role: PRINCIPAL_INVESTIGATOR

NECMETTİN ERBAKAN UNIVERSITY

Locations

NECMETTIN ERBAKAN University Faculty of Dentistry, Department of Periodontology,

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

D-KA11/06

Identifier Type: -

Identifier Source: org_study_id