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NCT Number: NCT07595757

Effect of Nano-Hyaluronic Acid in Intrabony Defects Treated With Minimally Invasive Non-Surgical Technique

This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hyaluronic acid (nano-HyA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intrabony defects in patients with Stage II and III periodontitis. While MINST is a proven method for cleaning deep periodontal pockets without the need for traditional surgery , the addition of nano-HyA may further enhance soft tissue healing, reduce inflammation, and promote regeneration. Participants in the study will be randomly assigned to one of two groups. The test group will receive the MINST procedure combined with the application of nano-HyA gel into the periodontal pocket, while the control group will receive the MINST procedure alone. The primary goal of the study is to measure the decrease in probing pocket depth over a 6-month follow-up period to determine if the adjunctive use of nano-HyA provides superior clinical and radiographic outcomes compared to non-surgical treatment alone

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females aged ≥ 18 years.
  • Patients with a diagnosis of periodontitis (stage II or III).
  • At least one tooth with ≥5 mm PPD and CAL and evidence of radiographic bone loss.
  • Presenting with at least 1 intrabony defect, with a radiographic intra-bony component ≥3 mm.

Exclusion criteria

  • Patients with systemic diseases.
  • Pregnant or lactating females.
  • Tobacco smokers (≥ 10 cigarettes per day).
  • Multi-rooted teeth with class II and class III furcation defects.
  • Third molars.
  • Teeth with grade III mobility.
  • Peri-apical pathology and acute abscess.
  • Non-surgical or surgical periodontal treatment in the past 12 months.
  • Prolonged treatment with antibiotics or anti-inflammatory agents within 6 months before periodontal therapy.

Treatment and study plan

Minimally invasive non-surgical technique (MINST)

Procedure

Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization

nano-hyaluronic acid

Biological

Pockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival debridement

Primary outcomes

  1. Pocket Depth (PD)

    Time frame: "From enrollment to the end of treatment at 24 weeks"

    Measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus using a UNC-15 periodontal probe. Each tooth is probed at 6 sites with a light force not exceeding 25 grams.

Secondary outcomes

  1. Full-Mouth Plaque Score (FMPS)

    Time frame: From enrollment to the end of treatment at 24 weeks

    Assessed as the percentage of sites with plaque.

  2. Full-Mouth Bleeding Score (FMBS)

    Time frame: From enrollment to the end of treatment at 24 weeks

    Assessed as the percentage of sites with bleeding upon probing.

  3. Clinical Attachment Level (CAL)

    Time frame: From enrollment to the end of treatment at 24 weeks

    Measured in millimeters (mm) from the cemento-enamel junction to the bottom of the pocket.

  4. Gingival Recession (GR)

    Time frame: From enrollment to the end of treatment at 24 weeks

    Measured in millimeters (mm) from the cemento-enamel junction to the gingival margin.

  5. Radiographic Defect Angle (RDA)

    Time frame: From enrollment to the end of treatment at 24 weeks

    Measured in degrees (°).

  6. Patient Satisfaction

    Time frame: From enrollment to the end of treatment at 24 weeks

    Assessed via a Likert-scale questionnaire. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied". Higher scores represent a better outcome.

  7. Cost Effectiveness

    Time frame: From enrollment to the end of treatment at 24 weeks

    Evaluated through a health economic analysis, measured as currency per unit effect.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Nano-Hyaluronic Acid as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intrabony Defects: Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 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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