L-PRF for Increasing Keratinised Mucosa Around Implants
L-PRF Membranes for Increasing the Width of Keratinised Mucosa Around Implants: A Split-mouth, Randomized, Controlled Pilot Clinical Trial
1 other identifier
interventional
8
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2016
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2017
CompletedFirst Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedJune 20, 2017
May 1, 2016
1.1 years
May 29, 2017
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of keratinised tissues
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 Outcomes (1)
Post-op pain assessment
Visual analogue scales were handed out after surgery and were collected 1 week post-operatively. Results will be presented in the final paper.
Study Arms (1)
L-PRF membranes
EXPERIMENTALIntra-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.
Interventions
split-mouth design, randomized L-PRF membranes vs. free gingival graft
split-mouth design, randomized L-PRF membranes vs. free gingival graft
Eligibility Criteria
You may qualify if:
- in need of bilateral enlargement of keratinsed tissues around implants
You may not qualify if:
- smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Gert-Jan Cleeren, MSc
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 16, 2017
Study Start
May 1, 2016
Primary Completion
May 27, 2017
Study Completion
May 27, 2017
Last Updated
June 20, 2017
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share