Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing

Study Overview
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Brief Summary
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This clinical study aims to investigate the impact of a topical hyaluronic acid (HA) gel on postoperative pain and wound healing at palatal donor sites in patients undergoing mucogingival procedures involving a de-epithelialized gingival graft (DGG) from the palate. The study design is a Phase III, randomized, double-blind, parallel-group, clinical trial, conducted in a single center, with 30 subjects aged 18-70 years.

Official Title
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Clinical Study to Evaluate the Effects of a Topical Hyaluronic Acid (HA) Gel on Postoperative Pain and Wound Healing at Palatal Donor Sites in Subjects Undergoing Mucogingival Procedures

Conditions
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Palatal Wound

Intervention / Treatment
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* Device: Hyaluronic acid
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, between 18-70 years of age Informed Consent Form signed and availability for the duration of the study Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study Clinical indication for mucogingival surgery that requires a de-epithelialized gingival graft (DGG) from the palate Willingness to provide information related to their medical history Minimum of 10 uncrowned permanent natural teeth (excluding third molars) Normal salivary flow Exclusion Criteria: Oral pathology, chronic disease, or a history of allergy to testing products Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study Subject participating in any other clinical study Subject pregnant or breastfeeding Subject allergic to oral care products, personal care consumer products, or their ingredients Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>A gel containing Hyaluronic acid in combination with a hemostatic sponge | Device: Hyaluronic acid<br>* Hyaluronic acid and hemostatic sponge<br>|
| Active Comparator: Group II<br>A hemostatic sponge alone | Device: Control<br>* Hemostatic sponge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing area | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter | Baseline | 
| Wound healing area | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter | 3 days after surgery | 
| Wound healing area | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter | 7 days after surgery | 
| Wound healing area | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter | 14 days after surgery | 
| Wound healing area | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter | 21 days after surgery | 
| Wound healing area | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter | 42 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. | Baseline | 
| Pain assessment | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. | 3 days after surgery | 
| Pain assessment | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. | 7 days after surgery | 
| Pain assessment | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. | 14 days after surgery | 
| Pain assessment | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. | 21 days after surgery | 
| Pain assessment | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. | 42 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical hyaluronic acid, Postoperative pain, Wound healing, Epithelialized, Palate, supportive care, Treatment, Prevention