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Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pakā¢) dressing in the management of free gingival graft and donor site palatal wound.
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-Pakā¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| A non-eugenol-based dressing | Experimental | A non-eugenol-based dressing (Coe-Pakā¢) will be used in both donor and receiving sites after a free gingival graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A free gingival graft | Procedure | A free gingival graft will be used for the treatment of gingival recession |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Abou Sulaiman, PhD. | Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damascus University | Damascus | 00963 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27761092 | Result | 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. | |
| 26313017 | Result | Femminella 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. |
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The Individual participant data will be only available for the researchers in the department of Periodontics, Damascus University
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| A Platelet-Rich Fibrin dressing | Device | A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft. |
|
| A non-eugenol-based dressing | Device | A non-eugenol-based dressing (Coe-Pakā¢) will be applied in both donor and receiving sites after the free gingival graft. |
|
This variable is going to be measured using the peroxide test. Scores are yes or no for showing bubbles. |
| 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. | 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. | 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. | The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement). |
| Plaque index | Score: none, simple, middle, severe. | 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. | 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. | 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. | The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement). |
| 25892528 | Result | Keceli 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. |
| 27088277 | Result | Keskiner 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. |
| 27538770 | Result | Ustaoglu 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. |
| 21731250 | Result | Shanmugam 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. |
| D055093 |
| Periodontal Atrophy |