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

May 15, 2026 updated by: Mustafa Hussein Alshebli, Cairo University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MINST alone
Participants receive the minimally invasive non-surgical technique (MINST) alone without adjunctive treatment
Procedure: Minimally invasive non-surgical technique (MINST)
Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization
Experimental: MINST + nano-hyaluronic acid
Participants receive MINST combined with adjunctive nano-hyaluronic acid
Procedure: Minimally invasive non-surgical technique (MINST)
Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization
Biological: nano-hyaluronic acid
Pockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"From enrollment to the end of treatment at 24 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 24 weeks
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.
From enrollment to the end of treatment at 24 weeks
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.
From enrollment to the end of treatment at 24 weeks
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.
From enrollment to the end of treatment at 24 weeks
Radiographic Defect Angle (RDA)
Time Frame: From enrollment to the end of treatment at 24 weeks
Measured in degrees (°).
From enrollment to the end of treatment at 24 weeks
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.
From enrollment to the end of treatment at 24 weeks
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.
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 29, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER 3-3 -2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on Minimally invasive non-surgical technique (MINST)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe