Hyaluronic AcidPhase 3NCT05990049
Hyaluronic Acid and Free Gingival Graft Healing
A Phase 3 study testing Hyadent BG in people with Hyaluronic Acid and Gingival Recession, Localized, run by University of Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyaluronic Acid, Gingival Recession, Localized, Pain, Postoperative
- What is being tested?
- Hyadent BG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no systemic disease
- healthy
- non-smokers
- at least one tooth with keratinized tissue width less than 2 mm
Who cannot join
- heavy smokers
- younger than 18years old
- using drugs
- allergy on anesthesia
- using drugs or alcohol
- undergoing chemotherapy
- undergoing radiotherapy
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
School of Dental Medicine University of Zagreb
Zagreb, 10000
Ana Badovinac, 098413512, badovinac@sfzg.hr
Marcela Daria Balic, balic.marcela@gmail.com
About this study
Official title: Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing
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.
Read the 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.
- Being tested
- Hyadent BG
- Keywords
- keratinized tissue width, shrinkage, hyaluronic acid, free gingival graft
- Medical subject headings
- Gingival Recession, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyadent BGDrug
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Active comparator | During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing. Receives: Drug: Hyadent BG |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized tissue gain
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Measured: baseline to 1 month postoperatively
Keratinized tissue gain
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Measured: baseline to 3 months postoperatively
Keratinized tissue gain
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
Measured: baseline to 6 months postoperatively
Shrinkage of the graft
changes of the graft in apico - coronal and mesio-distal dimensions
Measured: baseline to 1 month postoperatively
Shrinkage of the graft
changes of the graft in apico - coronal and mesio-distal dimensions
Measured: baseline to 3 months postoperatively
Shrinkage of the graft
changes of the graft in apico - coronal and mesio-distal dimensions
Measured: baseline to 6 months postoperatively
Secondary outcomes (3)
Dimensional changes in gingival recessions
reduction of gingival recessions
Measured: baseline to 1 month postoperative
Dimensional changes in gingival recessions
reduction of gingival recessions
Measured: baseline to 3 months postoperative
Dimensional changes in gingival recessions
reduction of gingival recessions
Measured: baseline to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Badovinac, University of Zagreb
- Investigators
- Ana Badovinac, assoc prof, Study director, School of Dental Medicine University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990049
- Sponsor's protocol ID
- 05-PA-30-V-2/2022.
- Status last verified
- Aug 2023
- First submitted
- 3 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing
- ClinicalTrials.gov ID
- NCT05990049
- Acronym / sponsor ID
- 05-PA-30-V-2/2022.
- Keywords
- keratinized tissue width, shrinkage, hyaluronic acid, free gingival graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Active comparator | Drug: Hyadent BGDuring the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no systemic disease
- healthy
- non-smokers
- at least one tooth with keratinized tissue width less than 2 mm
Key exclusion criteria (7 listed)
- heavy smokers
- younger than 18years old
- using drugs
- allergy on anesthesia
- using drugs or alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyadent BGHyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA) | Drug | Hyaluronic acid |
Primary outcome
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
3 secondary outcomes
Dimensional changes in gingival recessions
Time frame: baseline to 1 month postoperative
Dimensional changes in gingival recessions
Time frame: baseline to 3 months postoperative
Dimensional changes in gingival recessions
Time frame: baseline to 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Badovinac, assoc prof study director
School of Dental Medicine University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyadent BG in people with Hyaluronic Acid and Gingival Recession, Localized, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Badovinac (+38598413512, badovinac@sfzg.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratinized tissue gain (time frame: baseline to 1 month postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.