Application of Hyaluronic Acid in the Treatment of Periodontitis

Healing of Periodontal Suprabony Defects Following Treatment With Open Flap Debridement With or Without Hyaluronic Acid (HA) Application

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Bone Loss
• Intervention / Treatment: Procedure: Hyaluronic acid; Procedure: No-hyaluronic acid

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Ramaglia; Phone Number: +393476912911; Email: luca.ramaglia@unina.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • University of Naples Federico II
    • Contact: Luca Ramaglia; Phone Number: +393476912911; Email: luca.ramaglia@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid Group; Hyaluronic acid gel will be applied to exposed dental roots surfaces, after scaling and root planing therapy	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.
Active Comparator: No-hyaluronic acid Group; Only scaling and root planning will be performed on the exposed dental roots surfaces	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Probing Depth (PD) (millimeters)	Distance from the gingival margin to the bottom of the pocket	baseline, 6 months after surgical periodontal therapy
Change of Gingival Recession (GR) (millimeters)	Distance from gingival margin to the cementoenamel junction	baseline, 6 months after surgical periodontal therapy

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Periodontal Bone Loss; Suprabony Defect; Surgical Periodontal Therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 235/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No