Application of Hyaluronic Acid in the Treatment of Periodontitis

NCT05073575 | Recruiting DMC

• 1 other identifier: 235/21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Bone Loss

Keywords

Hyaluronic Acid; Suprabony Defect; Surgical Periodontal Therapy; Periodontal Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of Probing Depth (PD) (millimeters)

  baseline, 6 months after surgical periodontal therapy

• Change of Gingival Recession (GR) (millimeters)

  baseline, 6 months after surgical periodontal therapy

Study Arms (2)

Hyaluronic acid Group

EXPERIMENTAL

Hyaluronic acid gel will be applied to exposed dental roots surfaces, after scaling and root planing therapy

Procedure: Hyaluronic acid

No-hyaluronic acid Group

ACTIVE COMPARATOR

Only scaling and root planning will be performed on the exposed dental roots surfaces

Procedure: No-hyaluronic acid

Interventions

Hyaluronic acid PROCEDURE

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.

Hyaluronic acid Group

No-hyaluronic acid PROCEDURE

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

No-hyaluronic acid Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Luca Ramaglia

CONTACT

+393476912911; luca.ramaglia@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study will be designed as a double-arm randomized controlled clinical trial. The suprabony defects of subjects allocated in HA group will be treated with open flap debridement and application of hyaluronic acid, while the suprabony defects of No-HA Group will be treated with open flap debridement alone. The null hypothesis of no statistically significant differences between the two modalities for the treatment of suprabony defects will be tested.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 11, 2021
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)