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

EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING: A RANDOMIZED CONTROLLED CLINICAL STUDY

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.

Study Overview

• Status: Completed
• Conditions: Palatal Wound
• Intervention / Treatment: Procedure: FREE GİNGİVAL GRAFT; Device: polyvinylpyrrolidone sodium hyaluronate gel

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group - Free Gingival Graft	Procedure: FREE GİNGİVAL GRAFT; Free Gingival Graft removal from the palate donor area for the treatment of gingival recession
Experimental: Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel	Procedure: FREE GİNGİVAL GRAFT; Free Gingival Graft removal from the palate donor area for the treatment of gingival recession; Device: polyvinylpyrrolidone 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: sodium hyaluronate; Free gingival graft; WOUND HEALİNG; Polyvinylpyrrolidone; PALATAL
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Plasma Substitutes; Blood Substitutes; Viscosupplements; Povidone; Hyaluronic Acid
• Other Study ID Numbers: BAIBU-SBF-NE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes