Gingival RecessionNCT02712242
PRF for Accelerating Palatal Healing
A study testing Platelet Rich Fibrin, Butyl cyanoacrylate and Wet gauze in people with Gingival Recession, run by Cukurova University.
Trial summary
Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing. Read more about this study
- Who is it for?
- Ages 21 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Platelet Rich Fibrin, Butyl cyanoacrylate and Wet gauze
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Sep 2015
- 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 21 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no contraindications for periodontal surgery;
- full-mouth plaque score of <10%
- full-mouth bleeding score of <15%.
Who cannot join
- previously undergone surgery for a graft harvested from the palate
- presence of systemic disease or taking medication known to interfere with periodontal health
- smokers
- possible coagulation disorders
About this study
Official title: The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial
Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.
Read the detailed description
125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.
- Conditions
- Gingival Recession
- Being tested
- Platelet Rich Fibrin, Butyl cyanoacrylate, Wet gauze
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinOther
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.
Butyl cyanoacrylateOther
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.
Wet gauzeOther
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin | Experimental | PRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized Receives: Other: Platelet Rich Fibrin |
| Butyl cyanoacrylate | Active comparator | Butyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft Receives: Other: Butyl cyanoacrylate |
| Wet Gauze | Placebo comparator | Wet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft Receives: Other: Wet gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialization
Assessed according to the toluedine blue coloring
Measured: One month
Secondary outcomes (5)
Sensibility disorders
visual analogue scale scores
Measured: One month
feeding habits
visual analogue scale scores
Measured: One month
Delayed bleeding
Bleeding assesment for post-operative one week
Measured: 1 week
Immediate Bleeding
Bleeding assesment for post-operative one hour
Measured: 1 hour
Pain
Visual Analague Scale scores
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Ozcelik, Cukurova University
- Investigators
- Onur Ozcelik, Ph D, Study director, Cukurova University, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712242
- Sponsor's protocol ID
- CukurovaU8
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02712242
- Acronym / sponsor ID
- CukurovaU8
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.
Detailed description
125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Fibrin | Experimental | Other: Platelet Rich FibrinPRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized |
| Butyl cyanoacrylate | Active comparator | Other: Butyl cyanoacrylateButyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft |
| Wet Gauze | Placebo comparator | Other: Wet gauzeWet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft |
Who may qualify
- Ages
- 21 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- no contraindications for periodontal surgery;
- full-mouth plaque score of <10%
- full-mouth bleeding score of <15%.
Key exclusion criteria (4 listed)
- previously undergone surgery for a graft harvested from the palate
- presence of systemic disease or taking medication known to interfere with periodontal health
- smokers
- possible coagulation disorders
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 |
|---|---|---|
| Platelet Rich FibrinImmediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds. | Other | Platelet Rich Fibrin |
| Butyl cyanoacrylateImmediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds. | Other | Butyl cyanoacrylate |
| Wet gauzeImmediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds. | Other | Wet Gauze |
Primary outcome
Epithelialization
Time frame: One month
Assessed according to the toluedine blue coloring
5 secondary outcomes
Sensibility disorders
Time frame: One month
feeding habits
Time frame: One month
Delayed bleeding
Time frame: 1 week
Immediate Bleeding
Time frame: 1 hour
Pain
Time frame: 3 months
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 18 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
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Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
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Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
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.
Onur Ozcelik, Ph D study director
Cukurova University, Professor
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin, Butyl cyanoacrylate and Wet gauze in people with Gingival Recession, run by Cukurova University.
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 3 inclusion and 4 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 18 Mar 2016. 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. Some participants in this study may receive a placebo. 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?
Epithelialization (time frame: One month). 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 18 Mar 2016.