Clinical trial NCT05821725: Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palatal Wound
Keywords: Topical hyaluronic acid
Postoperative pain
Wound healing
Epithelialized
Palate
supportive care
Treatment
Prevention
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Wound healing area
timeFrame: Baseline
measure: Wound healing area
timeFrame: 3 days after surgery
measure: Wound healing area
timeFrame: 7 days after surgery
measure: Wound healing area
timeFrame: 14 days after surgery
measure: Wound healing area
timeFrame: 21 days after surgery
measure: Wound healing area
timeFrame: 42 days after surgery
Secondary outcomes:
measure: Pain assessment
timeFrame: Baseline
measure: Pain assessment
timeFrame: 3 days after surgery
measure: Pain assessment
timeFrame: 7 days after surgery
measure: Pain assessment
timeFrame: 14 days after surgery
measure: Pain assessment
timeFrame: 21 days after surgery
measure: Pain assessment
timeFrame: 42 days after surgery
Other outcomes:
Locations:
city: Guarulhos
country: Brazil
facility: Faveri Academy
state: São Paulo
Study officials:
affiliation: Faveri Academy
name: Marcelo Faveri, DDS, PhD
role: STUDY_DIRECTOR
References: