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Completed

NCT Number: NCT03589235

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A free gingival graft

Procedure

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

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-Pak™) will be applied in both donor and receiving sites after the free gingival graft.

Primary outcomes

  1. The pain score using the visual analogue scale (VAS)

    Time frame: The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery).

    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 outcomes

  1. Healing index for free gingival graft

    Time frame: The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery)..

    The healing index for free gingival graft is an ordinal score: very poor, poor, good, very good and excellent.

  2. The complete re-epithelialization of the palatal wound

    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).

    This variable is going to be measured using the peroxide test. Scores are yes or no for showing bubbles.

  3. Changes in gingival recession

    Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).

    Miller Class II of Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.

  4. Match color of the palatal wound

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

    VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contralateral palatal mucosa.

  5. Attached gingival width

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

    Measured from the Mucogingival junction to the gingival Groove.

  6. Plaque index

    Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).

    Score: none, simple, middle, severe.

  7. Gingival Index

    Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).

    Score: none, simple, middle. Severe.

  8. Bleeding on probing Index

    Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).

    Score: bleeding, none bleeding.

  9. Pocket Probing Depth

    Time frame: The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement).

    Score: normal, simple, middle, severe.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 17, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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