Impact of Hyaluronic Acid Gel on Pain and Healing After Oral Surgery
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
This study tests if a hyaluronic acid gel can help reduce pain and speed up healing for people who have oral surgery involving a graft from the palate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Colgate Palmolive Industry-sponsored |
| Locations | 1 site (Guarulhos, São Paulo) |
| Trial ID | NCT05821725 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates how a topical hyaluronic acid gel affects postoperative pain and wound healing in patients undergoing mucogingival procedures that involve taking a graft from the palate. The study is designed as a Phase III, randomized, double-blind, parallel-group trial with 30 participants aged 18 to 70 years. Participants will be monitored for pain levels and healing progress at the donor sites after surgery. The study aims to provide insights into the efficacy of hyaluronic acid in enhancing recovery from oral surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18-70 who require mucogingival surgery and have a sufficient number of natural teeth.
Not a fit: Patients with oral pathologies, chronic diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce postoperative pain and improve healing times for patients undergoing oral surgery.
How similar studies have performed: Other studies have shown promising results with the use of hyaluronic acid in wound healing, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Guarulhos, São Paulo
- Faveri Academy — Guarulhos, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Marcelo Faveri, DDS, PhD
- Email: mdfaveri@uol.com.br
- Phone: 551198644-9962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.