Gingival RecessionNCT05267015
PRF for Treating Maxillary Gingival Recession
A study testing Gingival coverage using coronally advanced flap and a connective tissue graft and Gingival coverage using coronally advanced flap and platelet rich fibrin membranes in people with Gingival Recession, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gingival coverage using coronally advanced flap and a connective tissue graft and Gingival coverage using coronally advanced flap and platelet rich fibrin membranes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 3 Jan 2021to 14 Nov 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than 18 years old
- Bilateral Miller class I + II recession in the upper jaw
Who cannot join
- Smokers
- Patients with systemic diseases that could interfere with the healing
- Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Arab American University
Ramallah, 240
About this study
Official title: PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial
This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.
- Conditions
- Gingival Recession
- Being tested
- Gingival coverage using coronally advanced flap and a connective tissue graft, Gingival coverage using coronally advanced flap and platelet rich fibrin membranes
- Keywords
- connective tissue graft, PRF membrane, gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival coverage using coronally advanced flap and a connective tissue graftProcedure or surgery
A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft
Gingival coverage using coronally advanced flap and platelet rich fibrin membranesProcedure or surgery
A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes
| Study group | Role | What they receive |
|---|---|---|
| coronally advanced flap with connective tissue graft | Active comparator | After randomization a subepithelial connective tissue graft along with coronally advanced flap is applied to one maxillary quadrant to cover the recession. Receives: Procedure: Gingival coverage using coronally advanced flap and a connective tissue graft |
| coronally advanced flap with platelet rich fibrin membranes | Experimental | After randomization platelet rich fibrin membranes along with coronally advanced flap are applied to the other maxillary quadrant to cover the recession. Receives: Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in gingival height (recession coverage)
The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks.
Measured: six weeks
Shrinkage in gingival height
To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months.
Measured: six months
Secondary outcomes (1)
Postoperative pain visual analog scores (VAS) and surgery time
This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start3 Jan 2021
- Primary completion15 Aug 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abu-Ta'a, Arab American University (Palestine)
- Investigators
- Mahmoud F Abu-Ta'a, Periodontist, Principal investigator, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267015
- Sponsor's protocol ID
- ArabAmericanU
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abu-Ta'a M. Advanced Platelet-Rich Fibrin and Connective Tissue Graft for Treating Marginal Tissue Recessions: A Randomized, Controlled Split-Mouth Study. Cureus. 2023 Mar 4;15(3):e35761. doi: 10.7759/cureus.35761. eCollection 2023 Mar.
PubMed 36879584
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05267015
- Acronym / sponsor ID
- ArabAmericanU
- Conditions
- Gingival Recession
- Keywords
- connective tissue graft, PRF membrane, gingival recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 4 Mar 2022 (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.
This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronally advanced flap with connective tissue graft | Active comparator | Procedure: Gingival coverage using coronally advanced flap and a connective tissue graftAfter randomization a subepithelial connective tissue graft along with coronally advanced flap is applied to one maxillary quadrant to cover the recession. |
| coronally advanced flap with platelet rich fibrin membranes | Experimental | Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranesAfter randomization platelet rich fibrin membranes along with coronally advanced flap are applied to the other maxillary quadrant to cover the recession. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than 18 years old
- Bilateral Miller class I + II recession in the upper jaw
Key exclusion criteria (3 listed)
- Smokers
- Patients with systemic diseases that could interfere with the healing
- Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.
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 |
|---|---|---|
| Gingival coverage using coronally advanced flap and a connective tissue graftA coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft | Procedure or surgery | coronally advanced flap with connective tissue graft |
| Gingival coverage using coronally advanced flap and platelet rich fibrin membranesA coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes | Procedure or surgery | coronally advanced flap with platelet rich fibrin membranes |
Primary outcome
Increase in gingival height (recession coverage)
Time frame: six weeks
The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks.
Shrinkage in gingival height
Time frame: six months
To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months.
1 secondary outcome
Postoperative pain visual analog scores (VAS) and surgery time
Time frame: two weeks
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 4 Mar 2022.
- Derived from this study: PubMed 36879584Abu-Ta'a M. Advanced Platelet-Rich Fibrin and Connective Tissue Graft for Treating Marginal Tissue Recessions: A Randomized, Controlled Split-Mouth Study. Cureus. 2023 Mar 4;15(3):e35761. doi: 10.7759/cureus.35761. eCollection 2023 Mar.
- 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.
Mahmoud F Abu-Ta'a, Periodontist principal investigator
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival coverage using coronally advanced flap and a connective tissue graft and Gingival coverage using coronally advanced flap and platelet rich fibrin membranes in people with Gingival Recession, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 2 inclusion and 3 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Increase in gingival height (recession coverage) (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267015, which also lists 1 linked publication.
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 4 Mar 2022.