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Chitosan and i-PRF in Palatal Wound Healing

B

Biruni University

Status

Completed

Conditions

i-PRF
Chitosan
Wound Healing
Free Gingival Graft

Treatments

Procedure: free gingival graft + chitosan
Procedure: free gingival graft + gelatin sponge
Procedure: free gingival graft + chitosan and i-PRF

Study type

Interventional

Funder types

Other

Identifiers

NCT07072546
Chitosan-iPRF

Details and patient eligibility

About

This study aims to evaluate the effects of chitosan and injectable platelet-rich fibrin (i-PRF) on wound healing at the donor site following free gingival graft (FGG) procedures. The palatal donor area often experiences delayed healing and postoperative discomfort, motivating the search for effective biomaterials to enhance recovery and reduce patient morbidity. Although various approaches have been investigated, the combined application of chitosan and i-PRF has not yet been explored in this context.

The study examines three patient groups treated at the periodontology departments of Çukurova and Biruni University: one with gelatin sponge (control), one with chitosan, and one with chitosan infused with i-PRF. Parameters such as pain (VAS), bleeding, burning sensation, dietary changes, epithelialization (PEHI score), and color match were assessed over a 2-month follow-up.

The findings are expected to provide insights into whether i-PRF-enhanced chitosan offers superior healing outcomes and greater patient comfort compared to conventional methods.

Enrollment

68 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Periodontally healthy
  • Having good oral hygiene (plaque accumulation <20%)
  • Requiring a free gingival graft (FGG) procedure in an area with insufficient keratinized gingiva width (<2 mm)

Exclusion criteria

  • Having systemic diseases contraindicating surgical procedures,
  • Uncontrolled diabetes (HbA1c > 7),
  • Being pregnant or breastfeeding,
  • Autoimmune and/or inflammatory diseases of the oral cavity,
  • Active periodontal disease,
  • Smokers (≥ 10 cigarettes per day)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 3 patient groups

control
Other group
Description:
control group
Treatment:
Procedure: free gingival graft + gelatin sponge
chitosan
Active Comparator group
Treatment:
Procedure: free gingival graft + chitosan
chitosan-iprf
Experimental group
Treatment:
Procedure: free gingival graft + chitosan and i-PRF

Trial contacts and locations

2

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Central trial contact

Mehmet Cenk Haytaç, PhD; Burcu Karaduman, PhD

Data sourced from clinicaltrials.gov

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