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

NCT ID: NCT05821725

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2023-11-21

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.

Detailed Description

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Conditions

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Palatal Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group I

A gel containing Hyaluronic acid in combination with a hemostatic sponge

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DEVICE

Hyaluronic acid and hemostatic sponge

Group II

A hemostatic sponge alone

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

Hemostatic sponge

Interventions

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Hyaluronic acid

Hyaluronic acid and hemostatic sponge

Intervention Type DEVICE

Control

Hemostatic sponge

Intervention Type DEVICE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcelo Faveri, DDS, PhD

Role: STUDY_DIRECTOR

Faveri Academy

Locations

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Faveri Academy

Guarulhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CRO-2022-09-WH-BZ-ZM

Identifier Type: -

Identifier Source: org_study_id

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