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EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING

A

Abant Izzet Baysal University

Status

Completed

Conditions

Palatal Wound

Treatments

Device: polyvinylpyrrolidone sodium hyaluronate gel
Procedure: FREE GİNGİVAL GRAFT

Study type

Interventional

Funder types

Other

Identifiers

NCT06610331
BAIBU-SBF-NE-01

Details and patient eligibility

About

The aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. This study included 32 systemically healthy patients who required free gingival graft surgery. After the operation, the test group received polyvinylpyrrolidone sodium hyaluronate gel in addition to chlorhexidine gluconate mouthwash, whereas the control group received only chlorhexidine gluconate mouthwash. VAS scale was used to evaluate palatal pain, burning, and chewing discomfort, WHI was used to evaluate wound healing, and H2O2 foaming test was used to evaluate epithelialization. VAS and bleeding values were recorded on postoperative day 1; VAS, WHI, H2O2, and bleeding values on postoperative days 3, 7, and 14; and WHI, H2O2, and bleeding values on postoperative day 28.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Able to adapt to the study, not having a physical or psychological condition that would prevent surgical procedure under local anesthesia, and being able to follow the planned operation and control sessions
  • Patients who consciously accept and sign the detailed informed consent form regarding the study that will be explained to them verbally
  • Insufficiently attached gingiva on the mandibular or maxillary vestibular teeth and implant surfaces

Exclusion criteria

  • Presence of infection and inflammation in the recipient and donor area
  • Presence of systemic disease
  • Women who are pregnant, suspected of being pregnant or breastfeeding
  • Smoking
  • Orofacial neurological symptoms

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups

Control Group - Free Gingival Graft
Sham Comparator group
Treatment:
Procedure: FREE GİNGİVAL GRAFT
Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel
Experimental group
Treatment:
Procedure: FREE GİNGİVAL GRAFT
Device: polyvinylpyrrolidone sodium hyaluronate gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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