PeriodontitisMINSTNCT07608783
Clinical Evaluation of Nano-Hydroxyapatite as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intra-bony Defects
A study testing Minimally invasive non-surgical technique (MINST) and nano-hydroxyapatite in people with Periodontitis and Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Intrabony Periodontal Defect
- What is being tested?
- Minimally invasive non-surgical technique (MINST) and nano-hydroxyapatite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Teeth with peri-apical pathology, acute abscess, or grade III mobility.
- Multi-rooted teeth with class II and class III furcation defects.
- Third molars.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University.
Cairo, 11511
About this study
Official 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
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
- Being tested
- Minimally invasive non-surgical technique (MINST), nano-hydroxyapatite
- Keywords
- Nano-Hydroxyapatite, MINST, Minimally Invasive Non-Surgical Technique, Periodontal Regeneration
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive non-surgical technique (MINST)Procedure or surgery
Subgingival debridement using thin ultrasonic tips and Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization
nano-hydroxyapatiteBiological
A single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following debridement
| Study group | Role | What they receive |
|---|---|---|
| MINST alone | Active comparator | Participants receive the minimally invasive non-surgical technique (MINST) alone without adjunctive treatment Receives: Procedure: Minimally invasive non-surgical technique (MINST) |
| MINST + nano-hydroxyapatite | Experimental | Participants receive MINST combined with the adjunctive application of nano-hydroxyapatite gel Receives: Procedure: Minimally invasive non-surgical technique (MINST); Biological: nano-hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth (PPD)
Measured in millimeters (mm) using a manual periodontal probe (UNC-15)
Measured: 6 months
Secondary outcomes (8)
Full-Mouth Plaque Score (FMPS)
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.
Measured: 1, 3, and 6 months post-treatment.
Full-Mouth Bleeding Score (FMBS)
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.
Measured: 1, 3, and 6 months post-treatment.
Clinical Attachment Level (CAL)
Measured in millimeters (mm) using a manual periodontal probe (UNC-15).
Measured: 1, 3, and 6 months post-treatment.
Gingival Recession (GR)
Measured in millimeters (mm) using a manual periodontal probe (UNC-15).
Measured: 1, 3, and 6 months post-treatment.
Radiographic Defect Angle (RDA)
Measured in degrees (°) utilizing standardized periapical radiographs and measurement software.
Measured: 1, 3, and 6 months post-treatment.
Patient Satisfaction
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.
Measured: 1, 3, and 6 months post-treatment.
Cost Effectiveness based on Clinical Attachment Level (CAL)
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.
Measured: 6 months post-treatment.
Cost Effectiveness based on Probing Pocket Depth (PPD)
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.
Measured: 6 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jul 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Eddin Sheet, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608783
- Sponsor's protocol ID
- PER 3 - 3 - 2
- Acronym
- MINST
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07608783
- Acronym / sponsor ID
- MINST / PER 3 - 3 - 2
- Conditions
- Periodontitis, Intrabony Periodontal Defect
- Keywords
- Nano-Hydroxyapatite, MINST, Minimally Invasive Non-Surgical Technique, Periodontal Regeneration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINST alone | Active comparator | Procedure: Minimally invasive non-surgical technique (MINST)Participants receive the minimally invasive non-surgical technique (MINST) alone without adjunctive treatment |
| MINST + nano-hydroxyapatite | Experimental | Procedure: Minimally invasive non-surgical technique (MINST), Biological: nano-hydroxyapatiteParticipants receive MINST combined with the adjunctive application of nano-hydroxyapatite gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | MINST + nano-hydroxyapatite, MINST alone |
| nano-hydroxyapatiteA single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following debridement | Biological | MINST + nano-hydroxyapatite |
Primary outcome
Probing Pocket Depth (PPD)
Time frame: 6 months
Measured in millimeters (mm) using a manual periodontal probe (UNC-15)
8 secondary outcomes
Full-Mouth Plaque Score (FMPS)
Time frame: 1, 3, and 6 months post-treatment.
Full-Mouth Bleeding Score (FMBS)
Time frame: 1, 3, and 6 months post-treatment.
Clinical Attachment Level (CAL)
Time frame: 1, 3, and 6 months post-treatment.
Gingival Recession (GR)
Time frame: 1, 3, and 6 months post-treatment.
Radiographic Defect Angle (RDA)
Time frame: 1, 3, and 6 months post-treatment.
Patient Satisfaction
Time frame: 1, 3, and 6 months post-treatment.
Cost Effectiveness based on Clinical Attachment Level (CAL)
Time frame: 6 months post-treatment.
Cost Effectiveness based on Probing Pocket Depth (PPD)
Time frame: 6 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive non-surgical technique (MINST) and nano-hydroxyapatite in people with Periodontitis and Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (PPD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.