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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05990049
Other study ID # 05-PA-30-V-2/2022.
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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