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Completed

NCT Number: NCT02712242

PRF for Accelerating Palatal Healing

Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.

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Key information

Conditions

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

Age range

21 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • no contraindications for periodontal surgery;
  • full-mouth plaque score of <10%
  • full-mouth bleeding score of <15%.

Exclusion criteria

  • previously undergone surgery for a graft harvested from the palate
  • presence of systemic disease or taking medication known to interfere with periodontal health
  • smokers
  • possible coagulation disorders

Treatment and study plan

platelet rich fibrin

Other

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.

Butyl cyanoacrylate

Other

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.

Wet gauze

Other

Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.

Primary outcomes

  1. Epithelialization

    Time frame: One month

    Assessed according to the toluedine blue coloring

Secondary outcomes

  1. Sensibility disorders

    Time frame: One month

    visual analogue scale scores

  2. feeding habits

    Time frame: One month

    visual analogue scale scores

  3. Delayed bleeding

    Time frame: 1 week

    Bleeding assesment for post-operative one week

  4. Immediate Bleeding

    Time frame: 1 hour

    Bleeding assesment for post-operative one hour

  5. Pain

    Time frame: 3 months

    Visual Analague Scale scores

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2016
Registry last updated
Mar 18, 2016

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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