Hyaluronic Acid and Free Gingival Graft Healing

• ClinicalTrials.gov Identifier: NCT05990049
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: August 16, 2023
• Sponsor: University of Zagreb
• Information provided by (Responsible Party): Ana Badovinac, University of Zagreb

Tracking Information

• First Submitted Date: July 3, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: August 16, 2023
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2023)

• Keratinized tissue gain [ Time Frame: baseline to 1 month postoperatively ]
  changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
• Keratinized tissue gain [ Time Frame: baseline to 3 months postoperatively ]
  changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
• Keratinized tissue gain [ Time Frame: baseline to 6 months postoperatively ]
  changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
• Shrinkage of the graft [ Time Frame: baseline to 1 month postoperatively ]
  changes of the graft in apico - coronal and mesio-distal dimensions
• Shrinkage of the graft [ Time Frame: baseline to 3 months postoperatively ]
  changes of the graft in apico - coronal and mesio-distal dimensions
• Shrinkage of the graft [ Time Frame: baseline to 6 months postoperatively ]
  changes of the graft in apico - coronal and mesio-distal dimensions

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 13, 2023)

• Dimensional changes in gingival recessions [ Time Frame: baseline to 1 month postoperative ]
  reduction of gingival recessions
• Dimensional changes in gingival recessions [ Time Frame: baseline to 3 months postoperative ]
  reduction of gingival recessions
• Dimensional changes in gingival recessions [ Time Frame: baseline to 6 months postoperative ]
  reduction of gingival recessions

Original Secondary Outcome Measures (submitted: August 4, 2023)

• Changes in gingival recessions [ Time Frame: baseline to 1 month postoperative ]
  reduction of gingival recessions
• Changes in gingival recessions [ Time Frame: baseline to 3 months postoperative ]
  reduction of gingival recessions
• Changes in gingival recessions [ Time Frame: baseline to 6 months postoperative ]
  reduction of gingival recessions

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hyaluronic Acid and Free Gingival Graft Healing
• Official Title: Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hyaluronic Acid
• Gingival Recession, Localized
• 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)

Study Arms

• Active Comparator: Hyaluronic acid
  During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.
  Intervention: Drug: Hyadent BG
• No Intervention: Control

  After the harvesting of the graft from the donor site, the wound will be sutured using only saline to clean the wound.

  On the recipient site, before positioning the graft, only saline will be used.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 4, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2024
• Estimated Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ana Badovinac; +38598413512; badovinac@sfzg.hr

• Listed Location Countries: Croatia

Administrative Information

• NCT Number: NCT05990049
• Other Study ID Numbers: 05-PA-30-V-2/2022.
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ana Badovinac, University of Zagreb
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Zagreb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ana Badovinac, assoc prof; School of Dental Medicine University of Zagreb

• PRS Account: University of Zagreb
• Verification Date: August 2023