Application of Hyaluronic Acid in the Treatment of Periodontitis
NCT ID: NCT05073575
Last Updated: 2024-02-28
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-01
2024-10-01
Brief Summary
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A total of 80 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group and no-hyaluronic acid group.
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Detailed Description
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Eighty patients with suprabony periodontal defects will be randomly assigned to treatment with open flap debridement and application of hyaluronic acid (HA Group) or open flap debridement alone (No-HA Group).
Primary outcome will be Clinical Attachment Level (CAL) gain, while the secondary outcomes will be Probing Depth (PD) and Gingival Recession (GR).
After local anesthesia, an access flap will be prepared. Depending on the mesiodistal width of the interproximal space, two different incision techniques will be selected to access the suprabony defect area. The modified papilla preservation technique (MMPT) will be used at sites with an interproximal width \> 2 mm, whereas the simplified papilla preservation technique (SPPT) will be applied at sites with an interproximal width ≤ 2 mm. Then, a mucoperiosteal flap will be reflected.
Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler.
Hyaluronic acid will be applied to exposed roots surface only in HA Group followed, for both groups, by a tension-free primary closure of the interdental papillae and of the mucoperiostal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hyaluronic acid Group
Hyaluronic acid gel will be applied to exposed dental roots surfaces, after scaling and root planing therapy
Hyaluronic acid
After local anesthesia, an access flap will be prepared. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler.
Hyaluronic acid gel will be applied to exposed roots surface, followed by a tension-free primary closure of the surgery wound by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.
No-hyaluronic acid Group
Only scaling and root planning will be performed on the exposed dental roots surfaces
No-hyaluronic acid
An access flap will be prepared in order to perform scaling and root planning therapy with the use of metal curettes.
After intervention, a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing materia will be performed
Interventions
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Hyaluronic acid
After local anesthesia, an access flap will be prepared. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler.
Hyaluronic acid gel will be applied to exposed roots surface, followed by a tension-free primary closure of the surgery wound by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.
No-hyaluronic acid
An access flap will be prepared in order to perform scaling and root planning therapy with the use of metal curettes.
After intervention, a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing materia will be performed
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Single-rooted and multi-rooted teeth
* Presence of suprabony periodontal defects at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth in either the maxilla or the mandible with a PD ≥ 5 mm after completion of non-surgical periodontal treatment and re-evaluation
* Intrabony defect with an intraosseous component \< 2 mm
Exclusion Criteria
* Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to surgery
* Pregnant or lactating
* Tobacco smokers (≥ 10 cigarettes per day)
* Multi-rooted teeth with furcation involvement
* Increased tooth mobility (grade II and III)
18 Years
70 Years
ALL
Yes
Sponsors
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Federico II University
OTHER
Responsible Party
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Luca Ramaglia
Clinical Professor
Locations
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University of Naples Federico II
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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235/21
Identifier Type: -
Identifier Source: org_study_id
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