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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05073575
Other study ID # 235/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date October 1, 2024

Study information

Verified date February 2024
Source Federico II University
Contact Luca Ramaglia
Phone +393476912911
Email luca.ramaglia@unina.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present investigation will be evaluated the healing of suprabony defects following surgical flap elevation and hyaluronic acid application respect to surgical flap elevation alone. 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.


Description:

The objective of the study will be compare the healing of suprabony defects following treatment with either open flap debridement (OFD) and application of hyaluronic acid (HA) with OFD alone. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients diagnosed with periodontitis - 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: - Patients with systemic diseases - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Italy University of Naples Federico II Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Clinical Attachment Level (CAL) gain (millimeters) Distance from the cementoenamel junction to the bottom of the pocket baseline, 6 months after surgical periodontal therapy
Secondary Change of Probing Depth (PD) (millimeters) Distance from the gingival margin to the bottom of the pocket baseline, 6 months after surgical periodontal therapy
Secondary Change of Gingival Recession (GR) (millimeters) Distance from gingival margin to the cementoenamel junction baseline, 6 months after surgical periodontal therapy
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