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

Not Applicable

Completed

• Conditions: Palatal Wound
• Interventions: Procedure: FREE GİNGİVAL GRAFT; Device: polyvinylpyrrolidone sodium hyaluronate gel

• Registration Number: NCT06610331
• Lead Sponsor: Abant Izzet Baysal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-07-10
• Study Completion: 2024-08-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group - Free Gingival Graft	FREE GİNGİVAL GRAFT	-
Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel	FREE GİNGİVAL GRAFT	-
Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel	polyvinylpyrrolidone sodium hyaluronate gel	-

Primary Outcome Measures

Name	Time	Method
Epithelialization	28 days	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.

Secondary Outcome Measures

Name	Time	Method
wound healing	28 days	Palatal wound healing was assessed using the Wound Healing Index (WHI) as described by Landry et al. (1985)

Trial Locations

Locations (1)

Bolu Abant Izzet Baysal University Faculty of Dentistry Department of Periodontology; 🇹🇷 Bolu, Turkey