Hyaluronic Acid and Free Gingival Graft Healing

Phase 3

Recruiting

• Conditions: Pain, Postoperative; Gingival Recession, Localized; Hyaluronic Acid
• Interventions: Drug: Hyadent BG

• Registration Number: NCT05990049
• Lead Sponsor: University of Zagreb

Brief Summary

This study aims to evaluate the impact of locally applied hyaluronic acid on free gingival graft wound bed healing and palatal donor site wound healing.

Forty subjects will be randomly divided in two separate groups. Test group will be treated with hyaluronic acid during the procedure and the control group without.

Periodontal parameters and other clinical measurements will be taken on baseline, 7 days postoperative, 14 days postoperative, 1 month, 3 months and 6 months postoperative.

Detailed Description

Free gingival graft is common, simple and predictable surgical procedure. Patients who have keratinized tissue width less than 2 mm will undergo the surgery after passing the inclusion criteria together with initial periodontal therapy. Total number of 40 patients will be divided in two separate groups; test group (hyaluronic acid) and control group based on random choice.The randomization will be examiner blind.

After the application of local anaesthesia, surgical procedure will be done in the same groups equally. In the recipient site, an horizontal incision will be performed on the mucogingival junction or 1-2 mm above it to include the free marginal gingiva. Partial thickness flap will be dissected in order to ensure the vascularisation of the graft. The size of the incision and graft will depend on the keratinized tissue width of the teeth area.

The graft will be taken from the donor site on the anterior palate in the area of premolars and molars. The graft will be measured with periodontal probe (UNC-15) in 3 dimensions over the flat surface and after the harvesting will be put in glass with saline. Donor site will be sutured using fibrin sponge and non-resorbable sutures. The size of recipient site and graft will depend on number of teeth with keratinized tissue width less than 2 mm.

The graft will be positioned on the recipient site and stabilised using non-resorbable suture performing single sutures and a sling suture around the tooth. The group of patients who will receive the hyaluronic acid will be treated on donor and recipient site before the suturing, applied once on the wound bed.

Postoperatively, patients will be instructed to rinse with 0.12% chlorhexidine digluconate twice a day. The patients will be asked to keep a diary for 7 days about pain sensations using VAS scale for donor and recipient site. An analgetic treatment will be prescribed if needed.

Recall visits will be 7 and 14 days postoperatively. The 7th day postoperatively will be removed sutures from donor site, and on 14th day the sutures from the graft and recipient site.

Clinical measurements with periodontal indices will be taken on 1, 3, and 6 months follow up.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-07-03
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-13
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-01-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• no systemic disease
• healthy
• non-smokers
• at least one tooth with keratinized tissue width less than 2 mm

Exclusion Criteria

• heavy smokers
• younger than 18years old
• using drugs
• allergy on anesthesia
• using drugs or alcohol
• undergoing chemotherapy
• undergoing radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyadent BG	During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.

Primary Outcome Measures

Name	Time	Method
Shrinkage of the graft	baseline to 6 months postoperatively	changes of the graft in apico - coronal and mesio-distal dimensions
Keratinized tissue gain	baseline to 6 months postoperatively	changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

Secondary Outcome Measures

Name	Time	Method
Dimensional changes in gingival recessions	baseline to 6 months postoperative	reduction of gingival recessions

Trial Locations

Locations (1)

School of Dental Medicine University of Zagreb; 🇭🇷 Zagreb, Croatia