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NCT Number: NCT05073575

Application of Hyaluronic Acid in the Treatment of Periodontitis

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.

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Key information

Conditions

Periodontal Bone Loss Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

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 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.

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
  • 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)

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: baseline, 6 months after surgical periodontal therapy

    Distance from the cementoenamel junction to the bottom of the pocket

Secondary outcomes

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

    Time frame: baseline, 6 months after surgical periodontal therapy

    Distance from the gingival margin to the bottom of the pocket

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

    Time frame: baseline, 6 months after surgical periodontal therapy

    Distance from gingival margin to the cementoenamel junction

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2021
Registry last updated
Sep 2, 2026

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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