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

NCT05821725 | Completed

• 1 other identifier: CRO-2022-09-WH-BZ-ZM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Palatal Wound

Keywords

Topical hyaluronic acid; Postoperative pain; Wound healing; Epithelialized; Palate; supportive care; Treatment; Prevention

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Pain assessment

  Baseline

• Pain assessment

  3 days after surgery

• Pain assessment

  7 days after surgery

• Pain assessment

  14 days after surgery

• Pain assessment

  21 days after surgery

Study Arms (2)

Group I

EXPERIMENTAL

A gel containing Hyaluronic acid in combination with a hemostatic sponge

Device: Hyaluronic acid

Group II

ACTIVE COMPARATOR

A hemostatic sponge alone

Device: Control

Interventions

Hyaluronic acid DEVICE

Hyaluronic acid and hemostatic sponge

Group I

Control DEVICE

Hemostatic sponge

Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Faveri Academy

Guarulhos, São Paulo, 04081-010, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marcelo Faveri, DDS, PhD

  Faveri Academy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 20, 2023
• Study Start: July 15, 2023
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: November 25, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)