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Completed

NCT Number: NCT02797899

Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft

Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and decrease pain scores.

Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form. The palatal donor area were evaluated for complete wound healing records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background: Despite a relatively painful surgical procedure, free gingival graft (FGG) is still commonly used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) after harvesting a FGG would improve soft tissue healing of donor sites and subsequently decrease pain scores.

Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Enrolled patients received periodontal examination, oral hygiene instructions and full-mouth debridement followed by standardized FGG of similar dimensions. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form to analyze pain scores including VAS, NRS-101, VRS-4 as well as three anxiety scales at base line. The palatal donor area were evaluated for complete wound healing based on the degree of color match, tissue texture, and contour of the surgical area compared to preoperative records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • lack of keratinized tissue in the mandibular central incisor region

Exclusion criteria

  • smoking
  • uncontrolled systemic disease that might contraindicate periodontal surgery
  • severe gag reflex preventing maxillary surgical procedure
  • inability or unwillingness to provide informed consent

Treatment and study plan

Platelet Rich Fibrin

Device

Native growth factors

Primary outcomes

  1. Changes in Visual Analog scale (VAS)

    Time frame: 1, 2, 3, 4 and 8 weeks

    a visual analog scale (VAS) consisting a 10-cm line with two extremes at either end. "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represent their level of perceived pain

Secondary outcomes

  1. Changes in contour of the surgical area

    Time frame: 1, 2, 3, 4 and 8 weeks

    To check for wound healing; contour of the surgical area was examined and compared to preoperative records

  2. Changes in degree of color match

    Time frame: 1, 2, 3, 4 and 8 weeks

    To check for wound healing; degree of color match was examined and compared to preoperative records

  3. Changes in tissue texture

    Time frame: 1, 2, 3, 4 and 8 weeks

    To check for wound healing; tissue texture was examined and compared to preoperative records

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Effect of Platelet Rich Fibrin Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2016
Registry last updated
Mar 13, 2024

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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