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Hyaluronic Acid and Free Gingival Graft Healing

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hyaluronic Acid Gingival Recession, Localized Pain, Postoperative Drug: Hyadent BG Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hyaluronic acid
During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.
 Drug: Hyadent BG
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Keratinized tissue gain [ Time Frame: baseline to 1 month postoperatively ]
    changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

  2. Keratinized tissue gain [ Time Frame: baseline to 3 months postoperatively ]
    changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

  3. Keratinized tissue gain [ Time Frame: baseline to 6 months postoperatively ]
    changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

  4. Shrinkage of the graft [ Time Frame: baseline to 1 month postoperatively ]
    changes of the graft in apico - coronal and mesio-distal dimensions

  5. Shrinkage of the graft [ Time Frame: baseline to 3 months postoperatively ]
    changes of the graft in apico - coronal and mesio-distal dimensions

  6. Shrinkage of the graft [ Time Frame: baseline to 6 months postoperatively ]
    changes of the graft in apico - coronal and mesio-distal dimensions


Secondary Outcome Measures :
  1. Dimensional changes in gingival recessions [ Time Frame: baseline to 1 month postoperative ]
    reduction of gingival recessions

  2. Dimensional changes in gingival recessions [ Time Frame: baseline to 3 months postoperative ]
    reduction of gingival recessions

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990049


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

Locations
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Croatia
School of Dental Medicine University of Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Ana Badovinac    098413512    badovinac@sfzg.hr   
Contact: Marcela Daria Balic       balic.marcela@gmail.com   
Sponsors and Collaborators
University of Zagreb
Investigators
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Study Director: Ana Badovinac, assoc prof School of Dental Medicine University of Zagreb
More Information
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Responsible Party: Ana Badovinac, assistant professor, University of Zagreb
ClinicalTrials.gov Identifier: NCT05990049    
Other Study ID Numbers: 05-PA-30-V-2/2022.
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 16, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Badovinac, University of Zagreb:
keratinized tissue width
shrinkage
hyaluronic acid
free gingival graft
Additional relevant MeSH terms:
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Gingival Recession
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy