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NCT Number: NCT07608783

Clinical Evaluation of Nano-Hydroxyapatite as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intra-bony Defects

This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hydroxyapatite (nHA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intra-bony defects in patients with Stage III periodontitis. While MINST is an effective method for cleaning deep periodontal pockets without the need for traditional surgery, the addition of nHA may further enhance soft tissue healing, improve cellular interaction, and promote bone 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 nHA gel directly 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 nHA provides superior clinical outcomes compared to non-surgical treatment alone.

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Key information

Conditions

Periodontitis Intrabony Periodontal Defect Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University.

Cairo, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systemically healthy adults aged 18-65 years.
  • No history of systemic diseases affecting periodontal status or bone metabolism (e.g., uncontrolled diabetes, osteoporosis).
  • Diagnosed with Stage III periodontitis according to the 2018 classification of periodontal diseases (with interdental CAL ≥5 mm, probing depth ≥6 mm).
  • Presence of at least one deep intra-bony defect (≥3 mm defect depth) in a single-rooted or multi-rooted tooth.
  • Willingness to participate and sign informed consent.

Exclusion criteria

  • Immunocompromised patients, uncontrolled diabetics (HbA1c ≥ 7.0%), or individuals with autoimmune disorders.
  • History of malignancy or chemotherapy/radiation in the past year.
  • Use of bisphosphonates, corticosteroids, immunosuppressive antibiotics or anti-inflammatory agents within 6 months before periodontal therapy.
  • Smokers (≥ 10 cigarettes per day).
  • Pregnant or breastfeeding women, confirmed via medical history and/or test.
  • Receipt of periodontal surgery or nonsurgical treatment within the last 6 months.
  • Teeth with peri-apical pathology, acute abscess, or grade III mobility.
  • Multi-rooted teeth with class II and class III furcation defects.
  • Third molars.

Treatment and study plan

Minimally invasive non-surgical technique (MINST)

Procedure

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

nano-hydroxyapatite

Biological

A single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following debridement

Primary outcomes

  1. Probing Pocket Depth (PPD)

    Time frame: 6 months

    Measured in millimeters (mm) using a manual periodontal probe (UNC-15)

Secondary outcomes

  1. Full-Mouth Plaque Score (FMPS)

    Time frame: 1, 3, and 6 months post-treatment.

    Assessed as a percentage (%) using the Visible Plaque Index (O'Leary et al.). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate a greater presence of plaque, representing a worse clinical outcome.

  2. Full-Mouth Bleeding Score (FMBS)

    Time frame: 1, 3, and 6 months post-treatment.

    Assessed as a percentage (%) using the Gingival Bleeding Index (Ainamo & Bay). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate more widespread gingival bleeding, representing a worse clinical outcome.

  3. Clinical Attachment Level (CAL)

    Time frame: 1, 3, and 6 months post-treatment.

    Measured in millimeters (mm) using a manual periodontal probe (UNC-15).

  4. Gingival Recession (GR)

    Time frame: 1, 3, and 6 months post-treatment.

    Measured in millimeters (mm) using a manual periodontal probe (UNC-15).

  5. Radiographic Defect Angle (RDA)

    Time frame: 1, 3, and 6 months post-treatment.

    Measured in degrees (°) utilizing standardized periapical radiographs and measurement software.

  6. Patient Satisfaction

    Time frame: 1, 3, and 6 months post-treatment.

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

  7. Cost Effectiveness based on Clinical Attachment Level (CAL)

    Time frame: 6 months post-treatment.

    Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of CAL improvement.

  8. Cost Effectiveness based on Probing Pocket Depth (PPD)

    Time frame: 6 months post-treatment.

    Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of PPD improvement.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Nano-Hydroxyapatite as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intra-bony Defects: A Randomized Controlled Clinical Trial

Acronym: MINST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 29, 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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