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

Colgate-Palmolive

Status: Completed

Conditions: Palatal Wound

Treatments: Device: Control; Device: Hyaluronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05821725

CRO-2022-09-WH-BZ-ZM

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Group I

Experimental group

Description:

A gel containing Hyaluronic acid in combination with a hemostatic sponge

Treatment:

Device: Hyaluronic acid

Group II

Active Comparator group

Description:

A hemostatic sponge alone

Treatment:

Device: Control