NCT07458685

Influence of Hyaluronic Acid in the Healing of Palatal Donor Sites During Free Gingival Graft Procedures

Efficacy of Cross-linked Hyaluronic Acid in Improving Healing After Free Gingival Graft: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the use of a gel containing cross-linked hyaluronic acid (xHyA) at the palatal donor site following soft tissue harvesting procedures. The main questions it aims to answer are: 1) Does the use of xHyA improve post-operative patient morbidity?; 2) Does the use of xHyA improve palatal donor site healing? Researchers will compare xHyA topically applied at the palatal donor site to a negative control to see if xHyA works to minimize participants' morbidity and improve clinical healing. Participants will be equally distributed into two groups, half of them receiving xHyA. Participants will fill a visual analogue scale for subjective analyses during the first 2 post-operative weeks and will visit the dental clinic at 3, 7, 14 and 60 post-operative days for checkups and clinical examinations.

Detailed description

The aim of the present study is to evaluate the effects of topical cross-linked high molecular weight hyaluronic acid (xHyA) gel on postoperative patient discomfort and wound healing of palatal donor sites after free gingival graft (FGG) surgery. Twenty patients requiring FGG are randomly assigned into two groups: negative control and a test group receiving xHyA gel in a single application. All surgical interventions are performed by the same surgical team. Anaesthesia of the palatal region is achieved with local infiltrations of mepivacaine 2% with epinephrine 1:100,000. The donor area is delimited by the distal line angle of the canine and the distal line angle of the second molar. A distance ≥ 2 mm from the gingival margin is respected. A half-thickness incision is made and a rectangular FGG with a thickness of ≈1.5 mm and dimensions of ≈20 × 5 mm in length x height respectively is harvested with a 15C scalpel under periodontal probe (PCP-UNC 15, Hu-Friedy Mfg. Co., LLC, Chicago, IL, USA) guidance maintaining a uniform thickness. A 1-minute moderate finger compression with a wet gauze is used to achieve initial haemostasis. Following soft tissue harvesting, in both groups a collagen sponge is placed to protect the palatal donor site, stabilized with cross-mattress sutures. In the test group, xHyA is injected over the exposed connective tissue and into the collagen sponge. In the negative control, the collagen sponge is left dry. In the immediate post-operative period, in order not to disturb the stabilization of the clot and the effects of the topical xHyA, participants are given instructions not to eat, drink, or rinse for about 4 hours. From the day after the surgery, participants are allowed to rinse passively with an ozone-based mouthwash (CollutO3, Innovares S.r.l., Reggio Emilia, Italy) for about 30 seconds twice daily for 2 post-operative weeks. Patients are placed on a soft diet with cold foods for the first week and are advised to avoid any mechanical or thermal trauma. Patients are also instructed not to brush and floss the upper teeth of the sector homolateral to the palatal donor area for one week. Nonsteroidal anti-inflammatory drugs (ibuprofen 600 mg every 6-8 hours up to 3 times a day) to be used as needed are prescribed for pain relief. Palatal sutures are removed after 7 days.

Conditions

• Palatal Donor Site Wound Healing
• Palatal Wound

Interventions

Type	Name	Description
DRUG	Test - xHyA	The xHyA gel is contained in a 1.2 mL sterile cartridge containing highly purified 1.6% high molecular weight cross-linked HA and 0.2% natural HA to be injected with a 23G blunt needle. The xHyA gel is applied directly over the exposed connective tissue at the donor area and injected inside a resorbable collagen sponge that is stabilized to the donor site with silk sutures. No further applications of xHyA are planned during the study.
OTHER	Negative control	A dry collagen sponge not loaded with xHyA is adapted and stabilized to the donor area with a 4-0 silk cross mattress suture.

Timeline

• Start date: 2022-09-05
• Primary completion: 2025-07-24
• Completion: 2025-10-02
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: Italy