Implantation ComplicationPhase 4NCT03190226
L-PRF for Increasing Keratinised Mucosa Around Implants
A Phase 4 study testing L-PRF membranes and Free Gingival Graft in people with Implantation Complication, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantation Complication
- What is being tested?
- L-PRF membranes and Free Gingival Graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 27 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in need of bilateral enlargement of keratinsed tissues around implants
Who cannot join
- smokers
About this study
Official title: 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.
- Conditions
- Implantation Complication
- Being tested
- L-PRF membranes, Free Gingival Graft
- Keywords
- L-PRF, keratinised tissues, implant, free gingival graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF membranesProcedure or surgery
split-mouth design, randomized L-PRF membranes vs. free gingival graft
Free Gingival GraftProcedure or surgery
split-mouth design, randomized L-PRF membranes vs. free gingival graft
| Study group | Role | What they receive |
|---|---|---|
| L-PRF membranes | Experimental | 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. Receives: Procedure: L-PRF membranes; Procedure: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of keratinised tissues
measurements of changes in amount of keratinised tissues
Measured: 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
Post-operative pain assessment via VAS-scales
Measured: Visual analogue scales were handed out after surgery and were collected 1 week post-operatively. Results will be presented in the final paper.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 May 2016
- Primary completion27 May 2017
- Study completion27 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantation ComplicationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- split-mouth trial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gert-Jan Cleeren, MSc, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190226
- Sponsor's protocol ID
- S57225
- Status last verified
- May 2016
- First submitted
- 29 May 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-PRF Membranes for Increasing the Width of Keratinised Mucosa Around Implants: A Split-mouth, Randomized, Controlled Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03190226
- Acronym / sponsor ID
- S57225
- Conditions
- Implantation Complication
- Keywords
- L-PRF, keratinised tissues, implant, free gingival graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 27 May 2017 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- split-mouth trial
| Arm | Type | Receives |
|---|---|---|
| L-PRF membranes | Experimental | Procedure: L-PRF membranes, Procedure: Free Gingival GraftIntra-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in need of bilateral enlargement of keratinsed tissues around implants
Key exclusion criteria (1 listed)
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-PRF membranessplit-mouth design, randomized L-PRF membranes vs. free gingival graft | Procedure or surgery | L-PRF membranes |
| Free Gingival Graftsplit-mouth design, randomized L-PRF membranes vs. free gingival graft | Procedure or surgery | L-PRF membranes |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gert-Jan Cleeren, MSc principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-PRF membranes and Free Gingival Graft in people with Implantation Complication, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017; AzTrials last refreshed its copy on 28 Oct 2026.