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

Palatal Wound Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821725
• Other study ID #: CRO-2022-09-WH-BZ-ZM
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Colgate Palmolive
• Contact: Marcelo Faveri, DDS, PhD
• Phone: 551198644-9962
• Email: mdfaveri[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Palatal Wound
• Wounds and Injuries

Intervention

Device:
• Hyaluronic acid
Hyaluronic acid and hemostatic sponge
• Control
Hemostatic sponge

Locations

Country	Name	City	State
Brazil	Faveri Academy	Guarulhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pain assessment	Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.	Baseline
Secondary	Pain assessment	Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.	3 days after surgery
Secondary	Pain assessment	Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.	7 days after surgery
Secondary	Pain assessment	Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.	14 days after surgery
Secondary	Pain assessment	Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.	21 days after surgery
Secondary	Pain assessment	Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.	42 days after surgery