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

May 27, 2026 updated by: Salah Eddin Sheet, Cairo University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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, Egypt, 11511
        • Oral Medicine and Periodontology department, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization
Experimental: MINST + nano-hydroxyapatite
Participants receive MINST combined with the adjunctive application of nano-hydroxyapatite gel
Procedure: Minimally invasive non-surgical technique (MINST)
Subgingival debridement using thin ultrasonic tips and Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization
Biological: nano-hydroxyapatite
A single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following debridement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth (PPD)
Time Frame: 6 months
Measured in millimeters (mm) using a manual periodontal probe (UNC-15)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level (CAL)
Time Frame: 1, 3, and 6 months post-treatment.
Measured in millimeters (mm) using a manual periodontal probe (UNC-15).
1, 3, and 6 months post-treatment.
Gingival Recession (GR)
Time Frame: 1, 3, and 6 months post-treatment.
Measured in millimeters (mm) using a manual periodontal probe (UNC-15).
1, 3, and 6 months post-treatment.
Radiographic Defect Angle (RDA)
Time Frame: 1, 3, and 6 months post-treatment.
Measured in degrees (°) utilizing standardized periapical radiographs and measurement software.
1, 3, and 6 months post-treatment.
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.
1, 3, and 6 months post-treatment.
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.
1, 3, and 6 months post-treatment.
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.
1, 3, and 6 months post-treatment.
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.
6 months post-treatment.
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.
6 months post-treatment.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PER 3 - 3 - 2

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.

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