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Randomized Controlled Trial
. 2025 Aug 8;25(1):1305.
doi: 10.1186/s12903-025-06677-w.

The effect of Polyvinylpyrrolidone-Sodium hyaluronate gel on palatal wound healing: a randomized controlled clinical trial

Tugba Bulut  1 , Nuray Ercan  2
Affiliations
Randomized Controlled Trial

The effect of Polyvinylpyrrolidone-Sodium hyaluronate gel on palatal wound healing: a randomized controlled clinical trial

Tugba Bulut et al. BMC Oral Health. .

Abstract

Background: This study evaluates the effect of polyvinylpyrrolidone sodium hyaluronate gel (Gelclair®) on palatal wound healing, pain, and bleeding following free gingival graft surgery (FGG).

Methods: Thirty-two patients undergoing FGG were randomly assigned to two groups: the test group received Gelclair® and chlorhexidine mouthwash, while the control group received only chlorhexidine. Patients were called at first, third, seventh, fourteenth and twenty-eighth postoperative days and, Visual Analog Scale (VAS), Wound Healing Index (WHI), hydrogen peroxide (H₂O₂) bubbling scores and bleeding situations were recorded. The Friedman test was used for repeated measures, with the Wilcoxon signed-rank test as post-hoc, and the Mann-Whitney U test for between-group comparisons.

Results: H₂O₂ test values significantly decreased and WHI values significantly increased over time in both groups (p < 0.050). Test and control groups comparison at time points showed the test group showed significantly lower H₂O₂ test values on days 7, 14, and 28 (p < 0.050) and higher WHI values on days 3, 7, 14, and 28 compared to control group. VAS pain, chewing, and burning scores were also significantly lower in the test group on days 1, 3, 7, and 14 compared to control. While on day 1, the control group had a bleeding rate of 105 times higher than the test group (p < 0.001), no significant differences were observed on days 3 and 7.

Conclusions: The findings suggest that Gelclair® promotes wound healing and reduces discomfort and bleeding in the palatal donor area after FGG.

Trial registration number: NCT06610331; Retrospectively registered on 23/09/2024.

Keywords: Donor site; Free gingival graft; Hyaluronic acid; Pain; Postoperative complications; Wound healing.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was approved by the Ethics Committee of Bolu Abant Izzet Baysal University (22/08/2023/255) and conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. Also, this study was registered on ClinicalTrials.gov (NCT06610331). All participants have signed informed consent forms and given their permission to use clinical information/video/photographic material for the analysis and publication of this study. Consent for publication: All participants have signed informed consent forms and given their permission to use clinical information/video/photographic material for the analysis and publication of this study. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram of the current trial
Fig. 2
Fig. 2
Images of the test and control groups on the operation, 1 st, 3rd, 7th, 14th, and 28th days
Fig. 3
Fig. 3
Box plot of the distribution of H2O2 test and WHI values for control and test groups on different days. Different letters mean statistically significant differences between time points in both groups (lower case for control and upper case for test group) p < 0.010. # Significant difference between the median values ​​of the Control and Test groups within the same time interval (cross-sectional) p < 0.010
Fig. 4
Fig. 4
Box plot of the distribution of VAS Pain, VAS Chewing and VAS Burning score for control and test groups on different days. Different letters mean statistically significant differences between time points in both groups (lower case for control and upper case for test group) p < 0.010. # Significant difference between the median values ​​of the Control and Test groups within the same time interval (cross-sectional) p < 0.010
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