Gingival RecessionNCT03589235
Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft
A study testing A free gingival graft, A Platelet-Rich Fibrin dressing and A non-eugenol-based dressing in people with Gingival Recession, run by Damascus University at 1 site in Syria.
Trial summary
Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- A free gingival graft, A Platelet-Rich Fibrin dressing and A non-eugenol-based dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 1 May 2017to 1 Feb 2019
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of Syrian descent.
- Systemically healthy.
- Attached gingival width ≤ 2 mm.
- Presence of type II (Miller Classification) of gingival recession.
Who cannot join
- Smoking.
- Pregnancy or lactating.
- Presence of any systematic diseases can affect the periodontal surgery.
- Subjects with significant moderate to severe periodontal disease.
- Patients under orthodontic treatment
- Presence of restorative materials (e.g. crown)
- Subjects have failed to maintain good plaque control.
- Subjects having previous surgical treatment for covering the recession in the chosen area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound
Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound.
Read the detailed description
Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor and receiving sites, coverage of gingival recession, and the gain of attached gingiva.
A total of 20 subjects will be invited to participate in this study from the patients seeking treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University.
The study has been approved by the investigator's local Review Board. Subjects will be recruited according to specific inclusion criteria. After completion of medical and dental history questionnaires, patients will sign a consent form after being advised about the nature of the study.
Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF) dressing will be used in both donor and receiving sites in the test group, while a non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the control group .
Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP) will be evaluated.
- Conditions
- Gingival Recession
- Being tested
- A free gingival graft, A Platelet-Rich Fibrin dressing, A non-eugenol-based dressing
- Keywords
- autografts, gingival recession, free gingival graft, Attached gingival width, Platelet-Rich Fibrin dressing
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A free gingival graftProcedure or surgery
A free gingival graft will be used for the treatment of gingival recession
A Platelet-Rich Fibrin dressingDevice
A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.
A non-eugenol-based dressingDevice
A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.
| Study group | Role | What they receive |
|---|---|---|
| A Platelet-Rich Fibrin dressing | Experimental | A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft. Receives: Procedure: A free gingival graft; Device: A Platelet-Rich Fibrin dressing |
| A non-eugenol-based dressing | Experimental | A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft. Receives: Procedure: A free gingival graft; Device: A non-eugenol-based dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain score using the visual analogue scale (VAS)
This variable is going to be measured by an visual analogue scale (VAS). The VAS pain scores ranges between 0 to10. (0: no pain, 1: minimal pain, 10: severe pain).
Measured: The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).
Secondary outcomes (9)
Healing index for free gingival graft
The healing index for free gingival graft is an ordinal score: very poor, poor, good, very good and excellent.
Measured: The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..
The complete re-epithelialization of the palatal wound
This variable is going to be measured using the peroxide test. Scores are yes or no for showing bubbles.
Measured: The measurements will be performed at T1 (after 1 week measurement), T2 (after 2 weeks measurement), T3 (after 3 weeks measurement), and T4 (after 4 weeks measurement).
Changes in gingival recession
Miller Class II of Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.
Measured: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Match color of the palatal wound
VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contralateral palatal mucosa.
Measured: The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).
Attached gingival width
Measured from the Mucogingival junction to the gingival Groove.
Measured: The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).
Plaque index
Score: none, simple, middle, severe.
Measured: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Gingival Index
Score: none, simple, middle. Severe.
Measured: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Bleeding on probing Index
Score: bleeding, none bleeding.
Measured: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Pocket Probing Depth
Score: normal, simple, middle, severe.
Measured: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 May 2017
- Primary completion1 Sep 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Abou Sulaiman, PhD., Study director, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589235
- Sponsor's protocol ID
- UDDS-Perio-02-2018
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data will be only available for the researchers in the department of Periodontics, Damascus University
Publications
Bansal M, Kumar A, Puri K, Khatri M, Gupta G, Vij H. Clinical and Histologic Evaluation of Platelet-Rich Fibrin Accelerated Epithelization of Gingival Wound. J Cutan Aesthet Surg. 2016 Jul-Sep;9(3):196-200. doi: 10.4103/0974-2077.191647.
PubMed 27761092Femminella 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 26313017Keceli HG, Aylikci BU, Koseoglu S, Dolgun A. Evaluation of palatal donor site haemostasis and wound healing after free gingival graft surgery. J Clin Periodontol. 2015 Jun;42(6):582-9. doi: 10.1111/jcpe.12404. Epub 2015 May 19.
PubMed 25892528Keskiner I, Lutfioglu M, Aydogdu A, Saygun NI, Serdar MA. Effect of Photobiomodulation on Transforming Growth Factor-beta1, Platelet-Derived Growth Factor-BB, and Interleukin-8 Release in Palatal Wounds After Free Gingival Graft Harvesting: A Randomized Clinical Study. Photomed Laser Surg. 2016 Jun;34(6):263-71. doi: 10.1089/pho.2016.4094. Epub 2016 Apr 18.
PubMed 27088277Ustaoglu G, Ercan E, Tunali M. The role of titanium-prepared platelet-rich fibrin in palatal mucosal wound healing and histoconduction. Acta Odontol Scand. 2016 Oct;74(7):558-564. doi: 10.1080/00016357.2016.1219045. Epub 2016 Aug 19.
PubMed 27538770Shanmugam M, Kumar TS, Arun KV, Arun R, Karthik SJ. Clinical and histological evaluation of two dressing materials in the healing of palatal wounds. J Indian Soc Periodontol. 2010 Oct;14(4):241-4. doi: 10.4103/0972-124X.76929.
PubMed 21731250
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound
- ClinicalTrials.gov ID
- NCT03589235
- Acronym / sponsor ID
- UDDS-Perio-02-2018
- Conditions
- Gingival Recession
- Keywords
- autografts, gingival recession, free gingival graft, Attached gingival width, Platelet-Rich Fibrin dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 17 Jul 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.
Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound.
Detailed description
Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor and receiving sites, coverage of gingival recession, and the gain of attached gingiva.
A total of 20 subjects will be invited to participate in this study from the patients seeking treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University.
The study has been approved by the investigator's local Review Board. Subjects will be recruited according to specific inclusion criteria. After completion of medical and dental history questionnaires, patients will sign a consent form after being advised about the nature of the study.
Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF) dressing will be used in both donor and receiving sites in the test group, while a non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the control group .
Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP) will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Platelet-Rich Fibrin dressing | Experimental | Procedure: A free gingival graft, Device: A Platelet-Rich Fibrin dressingA Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft. |
| A non-eugenol-based dressing | Experimental | Procedure: A free gingival graft, Device: A non-eugenol-based dressingA non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of Syrian descent.
- Systemically healthy.
- Attached gingival width ≤ 2 mm.
- Presence of type II (Miller Classification) of gingival recession.
Key exclusion criteria (8 listed)
- Smoking.
- Pregnancy or lactating.
- Presence of any systematic diseases can affect the periodontal surgery.
- Subjects with significant moderate to severe periodontal disease.
- Patients under orthodontic treatment
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 |
|---|---|---|
| A free gingival graftA free gingival graft will be used for the treatment of gingival recession | Procedure or surgery | A Platelet-Rich Fibrin dressing, A non-eugenol-based dressing |
| A Platelet-Rich Fibrin dressingA Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft. | Device | A Platelet-Rich Fibrin dressing |
| A non-eugenol-based dressingA non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft. | Device | A non-eugenol-based dressing |
Primary outcome
The pain score using the visual analogue scale (VAS)
Time frame: The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).
This variable is going to be measured by an visual analogue scale (VAS). The VAS pain scores ranges between 0 to10. (0: no pain, 1: minimal pain, 10: severe pain).
9 secondary outcomes
Healing index for free gingival graft
Time frame: The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..
The complete re-epithelialization of the palatal wound
Time frame: The measurements will be performed at T1 (after 1 week measurement), T2 (after 2 weeks measurement), T3 (after 3 weeks measurement), and T4 (after 4 weeks measurement).
Changes in gingival recession
Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Match color of the palatal wound
Time frame: The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).
Attached gingival width
Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).
Plaque index
Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Gingival Index
Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Bleeding on probing Index
Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Pocket Probing Depth
Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
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 Jul 2019.
- Results publication: PubMed 27761092Bansal M, Kumar A, Puri K, Khatri M, Gupta G, Vij H. Clinical and Histologic Evaluation of Platelet-Rich Fibrin Accelerated Epithelization of Gingival Wound. J Cutan Aesthet Surg. 2016 Jul-Sep;9(3):196-200. doi: 10.4103/0974-2077.191647.
- Results publication: 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.
- Results publication: PubMed 25892528Keceli HG, Aylikci BU, Koseoglu S, Dolgun A. Evaluation of palatal donor site haemostasis and wound healing after free gingival graft surgery. J Clin Periodontol. 2015 Jun;42(6):582-9. doi: 10.1111/jcpe.12404. Epub 2015 May 19.
- Results publication: PubMed 27088277Keskiner I, Lutfioglu M, Aydogdu A, Saygun NI, Serdar MA. Effect of Photobiomodulation on Transforming Growth Factor-beta1, Platelet-Derived Growth Factor-BB, and Interleukin-8 Release in Palatal Wounds After Free Gingival Graft Harvesting: A Randomized Clinical Study. Photomed Laser Surg. 2016 Jun;34(6):263-71. doi: 10.1089/pho.2016.4094. Epub 2016 Apr 18.
- Results publication: PubMed 27538770Ustaoglu G, Ercan E, Tunali M. The role of titanium-prepared platelet-rich fibrin in palatal mucosal wound healing and histoconduction. Acta Odontol Scand. 2016 Oct;74(7):558-564. doi: 10.1080/00016357.2016.1219045. Epub 2016 Aug 19.
- Results publication: PubMed 21731250Shanmugam M, Kumar TS, Arun KV, Arun R, Karthik SJ. Clinical and histological evaluation of two dressing materials in the healing of palatal wounds. J Indian Soc Periodontol. 2010 Oct;14(4):241-4. doi: 10.4103/0972-124X.76929.
- Individual participant dataSharing planned: No. The Individual participant data will be only available for the researchers in the department of Periodontics, Damascus University
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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.
Ali Abou Sulaiman, PhD. study director
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A free gingival graft, A Platelet-Rich Fibrin dressing and A non-eugenol-based dressing in people with Gingival Recession, run by Damascus University at 1 site in Syria.
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 4 inclusion and 8 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 Jul 2019. 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 Syria. 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?
The pain score using the visual analogue scale (VAS) (time frame: The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).). 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 NCT03589235, which also lists 6 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 18 Jul 2019.