Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft

NCT ID: NCT03589235

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-02-01

Brief Summary

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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

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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

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A Platelet-Rich Fibrin dressing

A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft.

Group Type EXPERIMENTAL

A free gingival graft

Intervention Type PROCEDURE

A free gingival graft will be used for the treatment of gingival recession

A Platelet-Rich Fibrin dressing

Intervention Type 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

A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft.

Group Type EXPERIMENTAL

A free gingival graft

Intervention Type PROCEDURE

A free gingival graft will be used for the treatment of gingival recession

A non-eugenol-based dressing

Intervention Type DEVICE

A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.

Interventions

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A free gingival graft

A free gingival graft will be used for the treatment of gingival recession

Intervention Type PROCEDURE

A Platelet-Rich Fibrin dressing

A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.

Intervention Type DEVICE

A non-eugenol-based dressing

A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Abou Sulaiman, PhD.

Role: STUDY_DIRECTOR

Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Locations

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Damascus University

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type RESULT
PMID: 27761092 (View on PubMed)

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.

Reference Type RESULT
PMID: 26313017 (View on PubMed)

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.

Reference Type RESULT
PMID: 25892528 (View on PubMed)

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.

Reference Type RESULT
PMID: 27088277 (View on PubMed)

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.

Reference Type RESULT
PMID: 27538770 (View on PubMed)

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.

Reference Type RESULT
PMID: 21731250 (View on PubMed)

Other Identifiers

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UDDS-Perio-02-2018

Identifier Type: -

Identifier Source: org_study_id

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