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

Not Applicable

Recruiting

• Conditions: Palatal Wound
• Interventions: Device: Control; Device: Hyaluronic acid

• Registration Number: NCT05821725
• Lead Sponsor: Colgate Palmolive

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-20
• Study Start: 2023-07-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Control	A hemostatic sponge alone
Group I	Hyaluronic acid	A gel containing Hyaluronic acid in combination with a hemostatic sponge

Primary Outcome Measures

Name	Time	Method
Wound healing area	42 days after surgery	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

Secondary Outcome Measures

Name	Time	Method
Pain assessment	42 days after surgery	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.

Trial Locations

Locations (1)

Faveri Academy; 🇧🇷 Guarulhos, São Paulo, Brazil