Periodontal DiseasePhase 1/2NCT07595757
Effect of Nano-Hyaluronic Acid in Intrabony Defects Treated With Minimally Invasive Non-Surgical Technique
A Phase 1/2 study testing Minimally invasive non-surgical technique (MINST) and nano-hyaluronic acid in people with Periodontal Disease and Periodontitis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease, Periodontitis
- What is being tested?
- Minimally invasive non-surgical technique (MINST) and nano-hyaluronic acid
- 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
- 15 Jul 2025to 29 Aug 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Periodontal Disease, Periodontitis
- Being tested
- Minimally invasive non-surgical technique (MINST), nano-hyaluronic acid
- Medical subject headings
- Periodontal Diseases, 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 additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization
nano-hyaluronic acidBiological
Pockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival 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-hyaluronic acid | Experimental | Participants receive MINST combined with adjunctive nano-hyaluronic acid Receives: Procedure: Minimally invasive non-surgical technique (MINST); Biological: nano-hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "From enrollment to the end of treatment at 24 weeks"
Secondary outcomes (7)
Full-Mouth Plaque Score (FMPS)
Assessed as the percentage of sites with plaque.
Measured: From enrollment to the end of treatment at 24 weeks
Full-Mouth Bleeding Score (FMBS)
Assessed as the percentage of sites with bleeding upon probing.
Measured: From enrollment to the end of treatment at 24 weeks
Clinical Attachment Level (CAL)
Measured in millimeters (mm) from the cemento-enamel junction to the bottom of the pocket.
Measured: From enrollment to the end of treatment at 24 weeks
Gingival Recession (GR)
Measured in millimeters (mm) from the cemento-enamel junction to the gingival margin.
Measured: From enrollment to the end of treatment at 24 weeks
Radiographic Defect Angle (RDA)
Measured in degrees (°).
Measured: From enrollment to the end of treatment at 24 weeks
Patient Satisfaction
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.
Measured: From enrollment to the end of treatment at 24 weeks
Cost Effectiveness
Evaluated through a health economic analysis, measured as currency per unit effect.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start15 Jul 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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 1/2
- 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, Mustafa Hussein Alshebli, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595757
- Sponsor's protocol ID
- PER 3-3 -2
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07595757
- Acronym / sponsor ID
- PER 3-3 -2
- Conditions
- Periodontal Disease, Periodontitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 19 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-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 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-hyaluronic acid | Experimental | Procedure: Minimally invasive non-surgical technique (MINST), Biological: nano-hyaluronic acidParticipants receive MINST combined with adjunctive nano-hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization | Procedure or surgery | MINST + nano-hyaluronic acid, MINST alone |
| nano-hyaluronic acidPockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival debridement | Biological | MINST + nano-hyaluronic acid |
Primary outcome
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.
7 secondary outcomes
Full-Mouth Plaque Score (FMPS)
Time frame: 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
Clinical Attachment Level (CAL)
Time frame: 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
Radiographic Defect Angle (RDA)
Time frame: From enrollment to the end of treatment at 24 weeks
Patient Satisfaction
Time frame: From enrollment to the end of treatment at 24 weeks
Cost Effectiveness
Time frame: From enrollment to the end of treatment at 24 weeks
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 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 1/2 study testing Minimally invasive non-surgical technique (MINST) and nano-hyaluronic acid in people with Periodontal Disease and Periodontitis, 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 4 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 19 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pocket Depth (PD) (time frame: "From enrollment to the end of treatment at 24 weeks"). 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 19 May 2026.