Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
A free gingival graft
A Platelet-Rich Fibrin dressing
A non-eugenol-based dressing
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring autografts, gingival recession, free gingival graft, Attached gingival width, Platelet-Rich Fibrin dressing
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.
Sites / Locations
- Damascus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A Platelet-Rich Fibrin dressing
A non-eugenol-based dressing
Arm Description
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 (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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 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.
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.
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.
Attached gingival width
Measured from the Mucogingival junction to the gingival Groove.
Plaque index
Score: none, simple, middle, severe.
Gingival Index
Score: none, simple, middle. Severe.
Bleeding on probing Index
Score: bleeding, none bleeding.
Pocket Probing Depth
Score: normal, simple, middle, severe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03589235
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
autografts, gingival recession, free gingival graft, Attached gingival width, Platelet-Rich Fibrin dressing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Platelet-Rich Fibrin dressing
Arm Type
Experimental
Arm Description
A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft.
Arm Title
A non-eugenol-based dressing
Arm Type
Experimental
Arm Description
A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft.
Intervention Type
Procedure
Intervention Name(s)
A free gingival graft
Intervention Description
A free gingival graft will be used for the treatment of gingival recession
Intervention Type
Device
Intervention Name(s)
A Platelet-Rich Fibrin dressing
Intervention Description
A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.
Intervention Type
Device
Intervention Name(s)
A non-eugenol-based dressing
Intervention Description
A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.
Primary Outcome Measure Information:
Title
The pain score using the visual analogue scale (VAS)
Description
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).
Time Frame
The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).
Secondary Outcome Measure Information:
Title
Healing index for free gingival graft
Description
The healing index for free gingival graft is an ordinal score: very poor, poor, good, very good and excellent.
Time Frame
The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..
Title
The complete re-epithelialization of the palatal wound
Description
This variable is going to be measured using the peroxide test. Scores are yes or no for showing bubbles.
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).
Title
Changes in gingival recession
Description
Miller Class II of Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.
Time Frame
The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Title
Match color of the palatal wound
Description
VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contralateral palatal mucosa.
Time Frame
The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).
Title
Attached gingival width
Description
Measured from the Mucogingival junction to the gingival Groove.
Time Frame
The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).
Title
Plaque index
Description
Score: none, simple, middle, severe.
Time Frame
The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Title
Gingival Index
Description
Score: none, simple, middle. Severe.
Time Frame
The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Title
Bleeding on probing Index
Description
Score: bleeding, none bleeding.
Time Frame
The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
Title
Pocket Probing Depth
Description
Score: normal, simple, middle, severe.
Time Frame
The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Abou Sulaiman, PhD.
Organizational Affiliation
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The Individual participant data will be only available for the researchers in the department of Periodontics, Damascus University
Citations:
PubMed Identifier
27761092
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.
Results Reference
result
PubMed Identifier
26313017
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.
Results Reference
result
PubMed Identifier
25892528
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.
Results Reference
result
PubMed Identifier
27088277
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. Erratum In: Photomed Laser Surg. 2018 Jan;36(1):58.
Results Reference
result
PubMed Identifier
27538770
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.
Results Reference
result
PubMed Identifier
21731250
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.
Results Reference
result
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Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft
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