Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth (PRF)

April 20, 2021 updated by: Franco Cavalla, University of Chile

Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density, scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of success in implant therapy avoiding further surgical interventions is key.

Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained from patients and that has shown promise of reducing the complications and improving the success of implant therapy, nevertheless its benefits in patients receiving implant retained overdentures has not been stablished. It is possible that PRF can improve the results and diminish the complications of implant therapy in older adults.

The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and beneficial for implant treatment in older adults suffering from complete tooth loss.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a split-mouth design randomized clinical trial assessing the effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in edentulous elderly adults.

Aim and purpose

  1. To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
  2. To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients.
  3. To examine soft tissues volumetric changes pre and post- surgery using intraoral scans and bone changes using cone-beam computed tomography (CBCT) around mandibular implants in edentulous patients.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mandibular edentulous
  • > 60 years old

Exclusion Criteria:

  • physical or psychological impediment for dental surgery
  • dental extraction < 6 months in the mandible
  • anticoagulant treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Implant installation with PRF
PRF membrane over the buccal aspect of implant site
Procedure: Implant installation with PRF membrane
Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
ACTIVE_COMPARATOR: Implant installation without PRF
Implant installation contralateral to the the experimental implant, without PRF membrane
Procedure: Implant installation without PRF membrane
Implant installation contralateral to the experimental side without PRF membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: 6 months
primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue thickness around implant neck
Time Frame: 6 months
Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact
6 months
Keratinized tissue width around implant neck
Time Frame: 6 months
Distance in mm of keratinized tissue from implant neck to mucogingival junction
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2020

Primary Completion (ANTICIPATED)

July 31, 2022

Study Completion (ANTICIPATED)

December 20, 2022

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (ACTUAL)

June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORF42004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Implant Failed

Clinical Trials on Implant installation with PRF membrane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe