L-PRF for Increasing Keratinised Mucosa Around Implants

June 19, 2017 updated by: Universitaire Ziekenhuizen KU Leuven

L-PRF Membranes for Increasing the Width of Keratinised Mucosa Around Implants: A Split-mouth, Randomized, Controlled Pilot Clinical Trial

The aim of this study was to evaluate the potential of L-PRF in increasing the width of the keratinsed mucosa around implants. Furthermore, it was assessed whether this surgery was associated with significantly less post-operative discomfort for the patient compared to Free Gingival Graft surgery. L-PRF for increasing keratinised mucosa around implants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • in need of bilateral enlargement of keratinsed tissues around implants

Exclusion Criteria:

  • smokers

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-PRF membranes

Intra-oral split thickness preparation - apically repositioned to the periosteum.

L-PRF membranes will be used to cover the site. Free Gingival Grafts will be used to cover the site.
Procedure: L-PRF membranes
split-mouth design, randomized L-PRF membranes vs. free gingival graft
Procedure: Free Gingival Graft
split-mouth design, randomized L-PRF membranes vs. free gingival graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of keratinised tissues
Time Frame: Measurements were performed pre-operatively (using lugol staining) and 3 months after surgery (using lugol staining). Results will be presented in the final paper.
measurements of changes in amount of keratinised tissues
Measurements were performed pre-operatively (using lugol staining) and 3 months after surgery (using lugol staining). Results will be presented in the final paper.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-op pain assessment
Time Frame: Visual analogue scales were handed out after surgery and were collected 1 week post-operatively. Results will be presented in the final paper.
Post-operative pain assessment via VAS-scales
Visual analogue scales were handed out after surgery and were collected 1 week post-operatively. Results will be presented in the final paper.

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Gert-Jan Cleeren, MSc, Universitaire Ziekenhuizen KU Leuven

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)

May 1, 2016

Primary Completion (Actual)

May 27, 2017

Study Completion (Actual)

May 27, 2017

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S57225

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

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

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