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Completed

NCT Number: NCT02190409

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NECMETTIN ERBAKAN University Faculty of Dentistry, Department of Periodontology,

Ankara, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period.

    Time frame: Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.

    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.

Secondary outcomes

  1. Evaluation of osseointegration in different types of bone

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

    Evaluation early bone healing and compare stability of different bone type (based on the bone quality determined by the insertion torque value)

Sponsors and collaborators

Lead sponsor

ELİF ONCU

Other

Collaborators

  • Baskent University

Registry information

Official study title

The Effect Of Platelet Rich Fibrin on Implant Stability

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2014
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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