Clinical trial NCT05990049: Hyaluronic Acid and Free Gingival Graft Healing
Official title: Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyaluronic Acid
Gingival Recession, Localized
Pain, Postoperative
Keywords: keratinized tissue width
shrinkage
hyaluronic acid
free gingival graft
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Keratinized tissue gain
timeFrame: baseline to 1 month postoperatively
measure: Keratinized tissue gain
timeFrame: baseline to 3 months postoperatively
measure: Keratinized tissue gain
timeFrame: baseline to 6 months postoperatively
measure: Shrinkage of the graft
timeFrame: baseline to 1 month postoperatively
measure: Shrinkage of the graft
timeFrame: baseline to 3 months postoperatively
measure: Shrinkage of the graft
timeFrame: baseline to 6 months postoperatively
Secondary outcomes:
measure: Dimensional changes in gingival recessions
timeFrame: baseline to 1 month postoperative
measure: Dimensional changes in gingival recessions
timeFrame: baseline to 3 months postoperative
measure: Dimensional changes in gingival recessions
timeFrame: baseline to 6 months postoperative
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine University of Zagreb
Study officials:
affiliation: School of Dental Medicine University of Zagreb
name: Ana Badovinac, assoc prof
role: STUDY_DIRECTOR
References: