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Hyaluronic Acid and Free Gingival Graft Healing

Primary Purpose

Hyaluronic Acid, Gingival Recession, Localized, Pain, Postoperative

Status
Recruiting
Phase
Phase 3
Locations
Croatia
Study Type
Interventional
Intervention
Hyadent BG
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyaluronic Acid focused on measuring keratinized tissue width, shrinkage, hyaluronic acid, free gingival graft

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dental Medicine University of ZagrebRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Hyaluronic acid

Control

Arm Description

During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.

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.

Outcomes

Primary Outcome Measures

Keratinized tissue gain
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Keratinized tissue gain
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Keratinized tissue gain
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Shrinkage of the graft
changes of the graft in apico - coronal and mesio-distal dimensions
Shrinkage of the graft
changes of the graft in apico - coronal and mesio-distal dimensions
Shrinkage of the graft
changes of the graft in apico - coronal and mesio-distal dimensions

Secondary Outcome Measures

Dimensional changes in gingival recessions
reduction of gingival recessions
Dimensional changes in gingival recessions
reduction of gingival recessions
Dimensional changes in gingival recessions
reduction of gingival recessions

Full Information

First Posted
July 3, 2023
Last Updated
August 13, 2023
Sponsor
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT05990049
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyaluronic Acid, Gingival Recession, Localized, Pain, Postoperative
Keywords
keratinized tissue width, shrinkage, hyaluronic acid, free gingival graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Active Comparator
Arm Description
During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyadent BG
Intervention Description
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
Primary Outcome Measure Information:
Title
Keratinized tissue gain
Description
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Time Frame
baseline to 1 month postoperatively
Title
Keratinized tissue gain
Description
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Time Frame
baseline to 3 months postoperatively
Title
Keratinized tissue gain
Description
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Time Frame
baseline to 6 months postoperatively
Title
Shrinkage of the graft
Description
changes of the graft in apico - coronal and mesio-distal dimensions
Time Frame
baseline to 1 month postoperatively
Title
Shrinkage of the graft
Description
changes of the graft in apico - coronal and mesio-distal dimensions
Time Frame
baseline to 3 months postoperatively
Title
Shrinkage of the graft
Description
changes of the graft in apico - coronal and mesio-distal dimensions
Time Frame
baseline to 6 months postoperatively
Secondary Outcome Measure Information:
Title
Dimensional changes in gingival recessions
Description
reduction of gingival recessions
Time Frame
baseline to 1 month postoperative
Title
Dimensional changes in gingival recessions
Description
reduction of gingival recessions
Time Frame
baseline to 3 months postoperative
Title
Dimensional changes in gingival recessions
Description
reduction of gingival recessions
Time Frame
baseline to 6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Badovinac
Phone
+38598413512
Email
badovinac@sfzg.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Badovinac, assoc prof
Organizational Affiliation
School of Dental Medicine University of Zagreb
Official's Role
Study Director
Facility Information:
Facility Name
School of Dental Medicine University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Badovinac
Phone
098413512
Email
badovinac@sfzg.hr
First Name & Middle Initial & Last Name & Degree
Marcela Daria Balic
Email
balic.marcela@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Hyaluronic Acid and Free Gingival Graft Healing

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