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Completed

NCT Number: NCT05188898

Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

About this study

The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of hyaluronic acid (HA) compared to MINSD alone.

Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of a hyaluronic acid-based gel (HA Group) or MINSD alone (No-HA Group).

Primary outcome will be "Probing Depth" (PD), while the secondary outcomes will be "Clinical Attachment Level" (CAL) gain, "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).

After local anesthesia, in HA group 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.

In the No-HA group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

MINSD

Other

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

Primary outcomes

  1. Change of Probing Depth (PD) (millimeters)

    Time frame: baseline and 6 months after periodontal therapy

    Distance from the gingival margin to the bottom of the pocket

Secondary outcomes

  1. Change of Clinical Attachment Level (CAL) gain (millimeters)

    Time frame: baseline and 6 months after periodontal therapy

    Distance from the Cement Enamel Junction (CEJ) to the bottom of the pocket

  2. Change of Gingival Recession (GR) (millimeters)

    Time frame: baseline and 6 months after periodontal therapy

    Distance from gingival margin to the cementoenamel junction

  3. Change of Radiographic Defect Angle (RDA) (grade °)

    Time frame: baseline and 6 months after periodontal therapy

    Radiographic intraosseous angle

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Hyaluronic Acid. A Randomized-controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2022
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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