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

NCT02190409 | Completed DMC

• 1 other identifier: D-KA11/06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

Dental Implant,

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Evaluation of osseointegration in different types of bone

  Resonance frequency measurements in different bone types were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.

Study Arms (1)

Test, Control

EXPERIMENTAL

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.

Device: Dental implant

Interventions

Dental implant 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

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

Test, Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ELİF ONCU: lead
• Baskent University: collaborator

Study Sites (1)

NECMETTIN ERBAKAN University Faculty of Dentistry, Department of Periodontology,

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• ELİF ÖNCÜ, 1

  NECMETTİN ERBAKAN UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist.Prof.Dr.

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 15, 2014
• Study Start: December 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

TU (1)