NCT03589235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

July 2, 2018

Last Update Submit

July 16, 2019

Conditions

Gingival Recession

Keywords

autograftsgingival recessionfree gingival graftAttached gingival widthPlatelet-Rich Fibrin dressing

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (9)

  • Healing index for free gingival graft

    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

    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

    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

    The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement).

  • Attached gingival width

    The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement).

  • +4 more secondary outcomes

Study Arms (2)

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.

Procedure: A free gingival graftDevice: 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.

Procedure: A free gingival graftDevice: A non-eugenol-based dressing

Interventions

A free gingival graftPROCEDURE

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

A Platelet-Rich Fibrin dressingA non-eugenol-based dressing
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 Platelet-Rich Fibrin dressing
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.

A non-eugenol-based dressing

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related Publications (6)

  • 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.

    PMID: 27761092RESULT

  • 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.

    PMID: 26313017RESULT

  • 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.

    PMID: 25892528RESULT

  • 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.

    PMID: 27088277RESULT

  • 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.

    PMID: 27538770RESULT

  • 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.

    PMID: 21731250RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Ali Abou Sulaiman, PhD.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 17, 2018

Study Start

May 1, 2017

Primary Completion

September 1, 2018

Study Completion

February 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

The Individual participant data will be only available for the researchers in the department of Periodontics, Damascus University

Locations

SY(1)