Wound HealingNCT03734328
Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal Healing
A study testing connective tissue graft and connective tissue graft&PRF in people with Wound Healing and Pain, Postoperative, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Subepithelial connective tissue graft (SCTG) has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Healing, Pain, Postoperative, Bleeding Wound
- What is being tested?
- connective tissue graft and connective tissue graft&PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2018to 1 Nov 2018
- 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
- who needed connective tissue graft for treating gingival recessions were included
Who cannot join
- Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
- smoking,
- nausea
- pregnancy/lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry
Denizli, Deni̇zli̇, 20070
About this study
Official title: Platelet Rich Fibrin Accelerates Wound Healing and Reduces Postoperative Complications of Palatal Subepithelial Connective Tissue Donor Site: a Controlled Randomized Clinical Trial
Subepithelial connective tissue graft (SCTG) has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues. Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia. Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement.Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after a subepithelial connective tissue graft procedure at palatal donor site.
Read the detailed description
Successful treatment of gingival recession (GR) is based on the use of clinically predictable periodontal plastic surgery (PPS) procedures. There are many procedures and different surgical procedures were proposed. Coronally advanced flap and subepithelial connective tissue graft (SCTG) is a good combination to increase the keratinized tissue width and reduce the amount of gingival recession.
SCTG has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues.
Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia.
Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement. The three-dimensional fibrin network and presence of many growth factors such as fibroblast growth factor, platelet-derived growth factor (PDGF) and epidermal growth factor supports effective neovascularization, accelerated wound closure and rapid cicatricial tissue remodeling. The strong fibrin architecture distinguishes it from other kinds of platelets concentrates and it seems responsible for the slow release of growth factors over a period of 7-14 days5. This period is seen as sufficient to prevent complications after connective tissue graft. Since the first description by Choukroun in 2000, PRF has been used in the clinical field for more than a decade in oral surgery and implant dentistry.
Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after connective tissue graft procedure at palatal donor site.
- Conditions
- Wound Healing, Pain, Postoperative, Bleeding Wound
- Being tested
- connective tissue graft, connective tissue graft&PRF
- Keywords
- connective tissue graft, platelet rich fibrin, patient perceptions, VAS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graftProcedure or surgery
- anesthesia of the palatal mucosa
- subepithelial connective tissue graft harvesting
- suturing (5/0 silk suture)
connective tissue graft&PRFProcedure or surgery
anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting
-suturing (5/0 silk suture)
connective tissue graft&PRFOther
- taking blood from patient
- centrifuging blood
- obtain PRF
| Study group | Role | What they receive |
|---|---|---|
| connective tissue graft | Active comparator | Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule)
Other names:
* 5/0 silk suture Receives: Procedure: connective tissue graft; Procedure: connective tissue graft&PRF; Other: connective tissue graft&PRF |
| connective tissue graft&PRF | Experimental | Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule)
Other names:
-5/0 silk suture Receives: Procedure: connective tissue graft; Procedure: connective tissue graft&PRF; Other: connective tissue graft&PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining wound healing to 40 patient with early healing index
to inspect the early wound healing on donor site on palate using early healing index on 3rd, 7th and 14th postoperatively. (1) complete flap closure, no fibrin line in the interproximal area; (2) complete flap closure, fine fibrin line in the interproximal area; (3) complete flap closure, fibrin clot in the interproximal area; (4) incomplete flap closure, partial necrosis of the interproximal tissue; and (5) incomplete flap closure, complete necrosis of the interproximal tissue
Measured: 14 days
postoperative pain
Patients were instructed to complete pain diary for the day at the surgery, first day, third day, seventh day, tenth day after surgery. The visual analog scale (VAS) that consists of a 10-cm line anchored by 2 extremes was used for perception measurements . Total score was 100 and less score was 0 according to this scale. According to this scale "0" means no pain, no discomfort during chewing and speaking, while the "100",meant 'worst pain, extreme discomfort during chewing and speaking'
Measured: 10 days
Secondary outcomes (1)
postoperative bleeding
Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period.
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start30 Jun 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSAN LEKTEMUR ALPAN, Pamukkale University
- Investigators
- Murat AKGUL, prof. dr., Principal investigator, Pamukkale University Faculty of Dentistry Department of Periodontolgy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734328
- Sponsor's protocol ID
- 60116787-020/44407
- Status last verified
- Nov 2018
- First submitted
- 3 Nov 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
PubMed 16504852Femminella B, Iaconi MC, Di Tullio M, Romano L, Sinjari B, D'Arcangelo C, De Ninis P, Paolantonio M. Clinical Comparison of Platelet-Rich Fibrin and a Gelatin Sponge in the Management of Palatal Wounds After Epithelialized Free Gingival Graft Harvest: A Randomized Clinical Trial. J Periodontol. 2016 Feb;87(2):103-13. doi: 10.1902/jop.2015.150198. Epub 2015 Aug 27.
PubMed 26313017
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin Accelerates Wound Healing and Reduces Postoperative Complications of Palatal Subepithelial Connective Tissue Donor Site: a Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03734328
- Acronym / sponsor ID
- 60116787-020/44407
- Conditions
- Wound Healing, Pain, Postoperative, Bleeding Wound
- Keywords
- connective tissue graft, platelet rich fibrin, patient perceptions, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 7 Nov 2018 (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.
Subepithelial connective tissue graft (SCTG) has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues. Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia. Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement.Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after a subepithelial connective tissue graft procedure at palatal donor site.
Detailed description
Successful treatment of gingival recession (GR) is based on the use of clinically predictable periodontal plastic surgery (PPS) procedures. There are many procedures and different surgical procedures were proposed. Coronally advanced flap and subepithelial connective tissue graft (SCTG) is a good combination to increase the keratinized tissue width and reduce the amount of gingival recession.
SCTG has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues.
Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia.
Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement. The three-dimensional fibrin network and presence of many growth factors such as fibroblast growth factor, platelet-derived growth factor (PDGF) and epidermal growth factor supports effective neovascularization, accelerated wound closure and rapid cicatricial tissue remodeling. The strong fibrin architecture distinguishes it from other kinds of platelets concentrates and it seems responsible for the slow release of growth factors over a period of 7-14 days5. This period is seen as sufficient to prevent complications after connective tissue graft. Since the first description by Choukroun in 2000, PRF has been used in the clinical field for more than a decade in oral surgery and implant dentistry.
Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after connective tissue graft procedure at palatal donor site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| connective tissue graft | Active comparator | Procedure: connective tissue graft, Procedure: connective tissue graft&PRF, Other: connective tissue graft&PRFDrug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: * 5/0 silk suture |
| connective tissue graft&PRF | Experimental | Procedure: connective tissue graft, Procedure: connective tissue graft&PRF, Other: connective tissue graft&PRFDrug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: -5/0 silk suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- who needed connective tissue graft for treating gingival recessions were included
Key exclusion criteria (4 listed)
- Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
- smoking,
- nausea
- pregnancy/lactation
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 |
|---|---|---|
| connective tissue graft* anesthesia of the palatal mucosa * subepithelial connective tissue graft harvesting * suturing (5/0 silk suture) | Procedure or surgery | connective tissue graft, connective tissue graft&PRF |
| connective tissue graft&PRFanesthesia of the palatal mucosa subepithelial connective tissue graft harvesting -suturing (5/0 silk suture) | Procedure or surgery | connective tissue graft, connective tissue graft&PRF |
| connective tissue graft&PRF* taking blood from patient * centrifuging blood * obtain PRF | Other | connective tissue graft, connective tissue graft&PRF |
Primary outcome
Defining wound healing to 40 patient with early healing index
Time frame: 14 days
to inspect the early wound healing on donor site on palate using early healing index on 3rd, 7th and 14th postoperatively. (1) complete flap closure, no fibrin line in the interproximal area; (2) complete flap closure, fine fibrin line in the interproximal area; (3) complete flap closure, fibrin clot in the interproximal area; (4) incomplete flap closure, partial necrosis of the interproximal tissue; and (5) incomplete flap closure, complete necrosis of the interproximal tissue
postoperative pain
Time frame: 10 days
Patients were instructed to complete pain diary for the day at the surgery, first day, third day, seventh day, tenth day after surgery. The visual analog scale (VAS) that consists of a 10-cm line anchored by 2 extremes was used for perception measurements . Total score was 100 and less score was 0 according to this scale. According to this scale "0" means no pain, no discomfort during chewing and speaking, while the "100",meant 'worst pain, extreme discomfort during chewing and speaking'
1 secondary outcome
postoperative bleeding
Time frame: 7days
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 9 Nov 2018.
- Background: PubMed 16504852Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
- Background: PubMed 26313017Femminella B, Iaconi MC, Di Tullio M, Romano L, Sinjari B, D'Arcangelo C, De Ninis P, Paolantonio M. Clinical Comparison of Platelet-Rich Fibrin and a Gelatin Sponge in the Management of Palatal Wounds After Epithelialized Free Gingival Graft Harvest: A Randomized Clinical Trial. J Periodontol. 2016 Feb;87(2):103-13. doi: 10.1902/jop.2015.150198. Epub 2015 Aug 27.
- 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.
Murat AKGUL, prof. dr. principal investigator
Pamukkale University Faculty of Dentistry Department of Periodontolgy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing connective tissue graft and connective tissue graft&PRF in people with Wound Healing and Pain, Postoperative, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 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 9 Nov 2018. 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 Turkey (Türkiye). 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?
Defining wound healing to 40 patient with early healing index (time frame: 14 days). 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 NCT03734328, which also lists 2 linked publications.
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 9 Nov 2018.