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

NCT07608783 | Active Not Recruiting

• 1 other identifier: PER 3 - 3 - 2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Intrabony Periodontal Defect

Keywords

Nano-Hydroxyapatite; MINST; Minimally Invasive Non-Surgical Technique; Periodontal Regeneration

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth (PPD)

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

  6 months

Secondary Outcomes (8)

• Full-Mouth Plaque Score (FMPS)

  1, 3, and 6 months post-treatment.

• Full-Mouth Bleeding Score (FMBS)

  1, 3, and 6 months post-treatment.

• Clinical Attachment Level (CAL)

  1, 3, and 6 months post-treatment.

• Gingival Recession (GR)

  1, 3, and 6 months post-treatment.

• Radiographic Defect Angle (RDA)

  1, 3, and 6 months post-treatment.

Study Arms (2)

MINST alone

ACTIVE COMPARATOR

Participants receive the minimally invasive non-surgical technique (MINST) alone without adjunctive treatment

Procedure: Minimally invasive non-surgical technique (MINST)

MINST + nano-hydroxyapatite

EXPERIMENTAL

Participants receive MINST combined with the adjunctive application of nano-hydroxyapatite gel

Procedure: Minimally invasive non-surgical technique (MINST); Biological: nano-hydroxyapatite

Interventions

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

MINST + nano-hydroxyapatite; MINST alone

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

MINST + nano-hydroxyapatite

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

nano-hydroxyapatite-collagen

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

EG (1)