Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure

Study Overview
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Brief Summary
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Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.

Detailed Description
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The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site. Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete. Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups. Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.

Official Title
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Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure

Conditions
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Wound Healing Complication

Intervention / Treatment
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* Drug: Periodontal dressing material
* Drug: 0.2% Hyaluronic acid gel
* Drug: 0.8% Hyaluronic acid gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health No periodontal surgical treatment in the previous 6 months on the involved sites Exclusion Criteria: Smoking Patients with a pregnancy or lactation period Self-reported history of antibiotic medication within three months Absence of tooth in the area of donor site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Periodontal dressing material<br>Palatal wound area was covered with periodontal dressing material at baseline and 3rd day | Drug: Periodontal dressing material<br>* Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day<br>* Other names: Peripac®;|
| Experimental: 0.2% Hyaluronic acid gel<br>0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day | Drug: 0.2% Hyaluronic acid gel<br>* 0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day<br>* Other names: Gengigel;|
| Experimental: 0.8% Hyaluronic acid gel<br>0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day | Drug: 0.8% Hyaluronic acid gel<br>* 0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day<br>* Other names: Gengigel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Using a visual analog scale (0: No pain, 10: Severe pain) | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color match | Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site) | 42 days | 
| Consistency | Soft/firm | 42 days | 
| Epithelialisation | None/partial/complete | 42 days | 
| Burning Sensation | Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation) | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingiva, Antiinflammatory, Hyaluronic acid, Palate, Transplants, Wound healing