Clinical trial

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

Name

05-PA-30-V-2/2022.

Description

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.

Trial arms

Trial start

2023-03-01

Estimated PCD

2024-01-01

Trial end

2024-03-01

Status

Recruiting

Phase

Early phase I

Treatment

Hyadent BG

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

Arms:

Hyaluronic acid

Size

Primary endpoint

Keratinized tissue gain

baseline to 1 month postoperatively

Keratinized tissue gain

baseline to 3 months postoperatively

Keratinized tissue gain

baseline to 6 months postoperatively

Shrinkage of the graft

baseline to 1 month postoperatively

Shrinkage of the graft

baseline to 3 months postoperatively

Shrinkage of the graft

baseline to 6 months postoperatively

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-08-16

1 organization

1 product

5 indications

Organization

Product

Indication

Indication

Indication

Indication

Indication