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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Palatal Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control Group - Free Gingival Graft

Group Type SHAM_COMPARATOR

FREE GİNGİVAL GRAFT

Intervention Type PROCEDURE

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

Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel

Group Type EXPERIMENTAL

FREE GİNGİVAL GRAFT

Intervention Type PROCEDURE

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

polyvinylpyrrolidone sodium hyaluronate gel

Intervention Type 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.

Interventions

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FREE GİNGİVAL GRAFT

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

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes