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CompletedNCT06610331Updated Sep 24, 2024

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

An interventional study of FREE GİNGİVAL GRAFT and polyvinylpyrrolidone sodium hyaluronate gel in Palatal Wound, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
  • Registered 7 months after the study started (first participant enrolled Feb 2024, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Palatal Wound

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Keywords

  • WOUND HEALİNG
  • sodium hyaluronate
  • Polyvinylpyrrolidone
  • Free gingival graft
  • PALATAL
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 32 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Sham comparator
    Control Group - Free Gingival Graft

    Procedure: FREE GİNGİVAL GRAFT

  • Experimental
    Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel

    Procedure: FREE GİNGİVAL GRAFT · Device: polyvinylpyrrolidone sodium hyaluronate gel

Interventions

  • ProcedureFREE GİNGİVAL GRAFT

    Free Gingival Graft removal from the palate donor area for the treatment of gingival recession

  • Devicepolyvinylpyrrolidone sodium hyaluronate gel

    Patients are told to gargle with a mouthwash containing polyvinyl pyrrolidone sodium hyaluronate twice a day for 2 weeks. 15 ml (1 tablespoon) of mouthwash containing polyvinyl pyrrolidone sodium hyaluronate is poured into a glass and approximately 40 ml (3 tablespoons) of water is added and mixed well, then it is shaken for at least 1 minute, making contact with the entire mouth.

06

What researchers measure

Primary outcomes

  1. Epithelialization

    Epithelialization of the palatal region was performed by applying 3% hydrogen peroxide to the wound area with the help of an injector, and the areas showing foaming (H2O2 bubbling) in the total surface area of the wound area were calculated as a percentage and recorded, providing information about epithelialization.

    Time frame: 28 days

Secondary outcomes

  1. wound healing

    Palatal wound healing was assessed using the Wound Healing Index (WHI) as described by Landry et al. (1985)

    Time frame: 28 days

07

Study locations

1 site
  • Bolu Abant Izzet Baysal University Faculty of Dentistry Department of Periodontology
    Bolu, 14000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06610331
Lead sponsor
Abant Izzet Baysal University
Responsible party
nuray Ercan (ASSISTANT PROFESSOR, Abant Izzet Baysal University) — Principal investigator
First posted
Sep 24, 2024
Start date
Feb 1, 2024
Primary completion
Jul 10, 2024
Completion
Aug 15, 2024
Last update
Sep 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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