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

NCT06610331 | Completed FDA Device

• 1 other identifier: BAIBU-SBF-NE-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palatal Wound

Keywords

WOUND HEALİNG; sodium hyaluronate; Polyvinylpyrrolidone; Free gingival graft; PALATAL

Outcome Measures

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.

  28 days

Secondary Outcomes (1)

• wound healing

  28 days

Study Arms (2)

Control Group - Free Gingival Graft

SHAM COMPARATOR

Procedure: FREE GİNGİVAL GRAFT

Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel

EXPERIMENTAL

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

Interventions

FREE GİNGİVAL GRAFT PROCEDURE

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

Control Group - Free Gingival Graft; Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel

polyvinylpyrrolidone sodium hyaluronate gel DEVICE

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.

Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University Faculty of Dentistry Department of Periodontology

Bolu, 14000, Turkey (Türkiye)

Location

Related Publications (1)

• Bulut T, Ercan N. The effect of Polyvinylpyrrolidone-Sodium hyaluronate gel on palatal wound healing: a randomized controlled clinical trial. BMC Oral Health. 2025 Aug 8;25(1):1305. doi: 10.1186/s12903-025-06677-w.

  PMID: 40781616 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: February 1, 2024
• Primary Completion: July 10, 2024
• Study Completion: August 15, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)