Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2023-03-01
2024-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hyaluronic acid
During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.
Hyadent BG
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
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.
No interventions assigned to this group
Interventions
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Hyadent BG
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
Eligibility Criteria
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Inclusion Criteria
* healthy
* non-smokers
* at least one tooth with keratinized tissue width less than 2 mm
Exclusion Criteria
* younger than 18years old
* using drugs
* allergy on anesthesia
* using drugs or alcohol
* undergoing chemotherapy
* undergoing radiotherapy
18 Years
70 Years
ALL
Yes
Sponsors
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University of Zagreb
OTHER
Responsible Party
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Ana Badovinac
assistant professor
Principal Investigators
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Ana Badovinac, assoc prof
Role: STUDY_DIRECTOR
School of Dental Medicine University of Zagreb
Locations
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School of Dental Medicine University of Zagreb
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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05-PA-30-V-2/2022.
Identifier Type: -
Identifier Source: org_study_id
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