Hyaluronic Acid and Free Gingival Graft Healing

Pain, Postoperative Clinical Trial

Official title:

Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990049
• Other study ID #: 05-PA-30-V-2/2022.
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2023
• Source: University of Zagreb
• Contact: Ana Badovinac
• Phone: +38598413512
• Email: badovinac[@]sfzg.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized
• Hyaluronic Acid
• Pain, Postoperative

Intervention

Drug:
• Hyadent BG
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)

Locations

Country	Name	City	State
Croatia	School of Dental Medicine University of Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratinized tissue gain	changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction	baseline to 1 month postoperatively
Primary	Keratinized tissue gain	changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction	baseline to 3 months postoperatively
Primary	Keratinized tissue gain	changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction	baseline to 6 months postoperatively
Primary	Shrinkage of the graft	changes of the graft in apico - coronal and mesio-distal dimensions	baseline to 1 month postoperatively
Primary	Shrinkage of the graft	changes of the graft in apico - coronal and mesio-distal dimensions	baseline to 3 months postoperatively
Primary	Shrinkage of the graft	changes of the graft in apico - coronal and mesio-distal dimensions	baseline to 6 months postoperatively
Secondary	Dimensional changes in gingival recessions	reduction of gingival recessions	baseline to 1 month postoperative
Secondary	Dimensional changes in gingival recessions	reduction of gingival recessions	baseline to 3 months postoperative
Secondary	Dimensional changes in gingival recessions	reduction of gingival recessions	baseline to 6 months postoperative