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

NCT07595757 | Active Not Recruiting Phase 1

• 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-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

Conditions

Periodontal Disease; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Pocket Depth (PD)

  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.

  "From enrollment to the end of treatment at 24 weeks"

Secondary Outcomes (7)

• Full-Mouth Plaque Score (FMPS)

  From enrollment to the end of treatment at 24 weeks

• Full-Mouth Bleeding Score (FMBS)

  From enrollment to the end of treatment at 24 weeks

• Clinical Attachment Level (CAL)

  From enrollment to the end of treatment at 24 weeks

• Gingival Recession (GR)

  From enrollment to the end of treatment at 24 weeks

• Radiographic Defect Angle (RDA)

  From enrollment to the end of treatment at 24 weeks

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-hyaluronic acid

EXPERIMENTAL

Participants receive MINST combined with adjunctive nano-hyaluronic acid

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

Interventions

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

MINST + nano-hyaluronic acid; MINST alone

nano-hyaluronic acid BIOLOGICAL

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

MINST + nano-hyaluronic acid

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's student, Periodontology

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: July 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

EG (1)