Clinical trial NCT03589235: Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft
Official title: Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: autografts
gingival recession
free gingival graft
Attached gingival width
Platelet-Rich Fibrin dressing
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients of Syrian descent.
* Systemically healthy.
* Attached gingival width ≤ 2 mm.
* Presence of type II (Miller Classification) of gingival recession.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The pain score using the visual analogue scale (VAS)
timeFrame: The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).
Secondary outcomes:
measure: Healing index for free gingival graft
timeFrame: The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..
measure: The complete re-epithelialization of the palatal wound
timeFrame: 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).
measure: Changes in gingival recession
timeFrame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
measure: Match color of the palatal wound
timeFrame: The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).
measure: Attached gingival width
timeFrame: The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).
measure: Plaque index
timeFrame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
measure: Gingival Index
timeFrame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
measure: Bleeding on probing Index
timeFrame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
measure: Pocket Probing Depth
timeFrame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Ali Abou Sulaiman, PhD.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.