Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid

NCT05188898 | Completed DMC

• 1 other identifier: 141/21
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of a hyaluronic acid-based gel, compared to MINSD alone. A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group (HA) and no-hyaluronic acid group (No-HA).

Conditions

Periodontal Bone Loss; Periodontal Pocket

Keywords

Hyaluronic Acid; Periodontal therapy; Periodontal Bone Loss; Intraosseous Bone Defect

Outcome Measures

Primary Outcomes (1)

• Change of Probing Depth (PD) (millimeters)

  Distance from the gingival margin to the bottom of the pocket

  baseline and 6 months after periodontal therapy

Secondary Outcomes (3)

• Change of Clinical Attachment Level (CAL) gain (millimeters)

  baseline and 6 months after periodontal therapy

• Change of Gingival Recession (GR) (millimeters)

  baseline and 6 months after periodontal therapy

• Change of Radiographic Defect Angle (RDA) (grade °)

  baseline and 6 months after periodontal therapy

Study Arms (2)

Hyaluronic acid Group

EXPERIMENTAL

Hyaluronic acid gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)

Other: MINSD and Hyaluronic acid

No-hyaluronic acid Group

ACTIVE COMPARATOR

Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed

Other: MINSD

Interventions

MINSD and Hyaluronic acid OTHER

After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, a hyaluronic acid-based gel will be applied to the intraosseous periodontal pockets.

Hyaluronic acid Group

MINSD OTHER

Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

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;
• Presence of at least 10 teeth per arch;
• Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
• Presence of at least one intraosseous pocket;
• Single-rooted and multi-rooted teeth.

You may not qualify if:

• Patients with systemic diseases;
• Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
• Pregnant or lactating;
• Tobacco smokers (≥ 10 cigarettes per day);
• Multi-rooted teeth with furcation involvement;
• Third molars.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• Iorio-Siciliano V, Blasi A, Mauriello L, Salvi GE, Ramaglia L, Sculean A. Non-Surgical Treatment of Moderate Periodontal Intrabony Defects With Adjunctive Cross-Linked Hyaluronic Acid: A Single-Blinded Randomized Controlled Clinical Trial. J Clin Periodontol. 2025 Feb;52(2):310-322. doi: 10.1111/jcpe.14078. Epub 2024 Oct 14.

  PMID: 39402910 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontal Pocket

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

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 intraosseous defects of subjects allocated in HA group will be treated with MINSD and application of hyaluronic acid, while in No-HA Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: January 12, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)