Periodontitis (Stage 3)NCT07071467
Testing Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management
A study testing Scaling and root planing with sodium hypochlorite and hyaluronic acid and Scaling and root planing in people with Periodontitis (Stage 3) and Periodontitis, run by Karim Ismail at 1 site in Egypt.
Trial summary
The study was designed to evaluate the concept of the clean \& seal, using sodium hypochlorite gel and hyaluronic acid as adjunctive to non-surgical therapy for management of Stage III Periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Periodontitis (Stage 3), Periodontitis
- What is being tested?
- Scaling and root planing with sodium hypochlorite and hyaluronic acid and Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes diagnosed with periodontitis Stage III.
- CAL ≥ 5mm or bone loss affecting middle third of the root in more than two adjacent teeth.
- PPD ≥ 6mm in more than two adjacent teeth.
- Periodontal tooth loss ≤ 4 teeth.
- Systemically healthy patients.
Who cannot join
- Patient with uncontrolled diabetes.
- Pregnant or lactating.
- Tobacco smoker ≥ 10 cigarettes/day.
- Antibiotic treatment within previous 4 weeks.
- Acute periodontal or periapical abscess
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Clean-Seal Technique Incorporating Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management
The study was designed to evaluate the concept of the clean \& seal, using sodium hypochlorite gel and hyaluronic acid as adjunctive to non-surgical therapy for management of Stage III Periodontitis.
- Conditions
- Periodontitis (Stage 3), Periodontitis
- Being tested
- Scaling and root planing with sodium hypochlorite and hyaluronic acid, Scaling and root planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planing with sodium hypochlorite and hyaluronic acidOther
Sodium hypochlorite gel was applied first for 30 seconds, then followed by subgingival instrumentation of the site. Then, 1.8% hyaluronic acid (1.6% cross-linked, 0.2% natural hyaluronic acid ) was applied subgingivally into the periodontal pocket to seal the site.
Scaling and root planingProcedure or surgery
Pockets were treated with sub-gingival scalling and root planning alone.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planing with sodium hypochlorite and hyaluronic acid | Experimental | Not described Receives: Other: Scaling and root planing with sodium hypochlorite and hyaluronic acid |
| Scaling and root planing | Active comparator | Not described Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque accumulation
This was assessed using O'Leary plaque index. The O'Leary Plaque Index records the presence or absence of dental plaque on four surfaces (mesial, distal, buccal, lingual) of each tooth. The score ranges from 0% (no plaque) to 100% (plaque on all surfaces), with lower percentages indicating better oral hygiene.
Measured: up to 12 weeks
Gingival condition assessment
The Gingival Index of Löe and Silness was used to assess the severity of gingival inflammation based on color, consistency, and bleeding on probing across four areas per tooth. Scores range from 0 (normal gingiva) to 3 (severe inflammation with spontaneous bleeding), with higher scores indicating worse gingival health.
Measured: up to 12 weeks
Secondary outcomes (2)
Probing depth
Probing Depth is the measurement of the distance from the gingival margin to the bottom of the periodontal pocket using a periodontal probe. Values typically range from 1-3 mm (healthy) to ≥5 mm (indicative of periodontal disease), with deeper pockets reflecting more severe attachment loss.
Measured: up to 12 weeks
Clinical attachment loss
Clinical Attachment Loss measures the distance from the cementoenamel junction to the base of the periodontal pocket, indicating the extent of periodontal support lost. Values range from 0 mm (no attachment loss) to ≥5 mm or more (severe loss), with higher measurements reflecting greater periodontal destruction.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2023
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karim Ismail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karim Ismail, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071467
- Sponsor's protocol ID
- 9208891
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Clean-Seal Technique Incorporating Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management
- ClinicalTrials.gov ID
- NCT07071467
- Acronym / sponsor ID
- 9208891
- Conditions
- Periodontitis (Stage 3), Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karim IsmailUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 17 Jul 2025 (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.
The study was designed to evaluate the concept of the clean \& seal, using sodium hypochlorite gel and hyaluronic acid as adjunctive to non-surgical therapy for management of Stage III Periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing with sodium hypochlorite and hyaluronic acid | Experimental | Other: Scaling and root planing with sodium hypochlorite and hyaluronic acid |
| Scaling and root planing | Active comparator | Procedure: Scaling and root planing |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both sexes diagnosed with periodontitis Stage III.
- CAL ≥ 5mm or bone loss affecting middle third of the root in more than two adjacent teeth.
- PPD ≥ 6mm in more than two adjacent teeth.
- Periodontal tooth loss ≤ 4 teeth.
- Systemically healthy patients.
Key exclusion criteria (5 listed)
- Patient with uncontrolled diabetes.
- Pregnant or lactating.
- Tobacco smoker ≥ 10 cigarettes/day.
- Antibiotic treatment within previous 4 weeks.
- Acute periodontal or periapical abscess
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 |
|---|---|---|
| Scaling and root planing with sodium hypochlorite and hyaluronic acidSodium hypochlorite gel was applied first for 30 seconds, then followed by subgingival instrumentation of the site. Then, 1.8% hyaluronic acid (1.6% cross-linked, 0.2% natural hyaluronic acid ) was applied subgingivally into the periodontal pocket to seal the site. | Other | Scaling and root planing with sodium hypochlorite and hyaluronic acid |
| Scaling and root planingPockets were treated with sub-gingival scalling and root planning alone. | Procedure or surgery | Scaling and root planing |
Primary outcome
Plaque accumulation
Time frame: up to 12 weeks
This was assessed using O'Leary plaque index. The O'Leary Plaque Index records the presence or absence of dental plaque on four surfaces (mesial, distal, buccal, lingual) of each tooth. The score ranges from 0% (no plaque) to 100% (plaque on all surfaces), with lower percentages indicating better oral hygiene.
Gingival condition assessment
Time frame: up to 12 weeks
The Gingival Index of Löe and Silness was used to assess the severity of gingival inflammation based on color, consistency, and bleeding on probing across four areas per tooth. Scores range from 0 (normal gingiva) to 3 (severe inflammation with spontaneous bleeding), with higher scores indicating worse gingival health.
2 secondary outcomes
Probing depth
Time frame: up to 12 weeks
Clinical attachment loss
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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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 Scaling and root planing with sodium hypochlorite and hyaluronic acid and Scaling and root planing in people with Periodontitis (Stage 3) and Periodontitis, run by Karim Ismail 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 5 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: finished, as of the sponsor's last update on 17 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plaque accumulation (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. 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 17 Jul 2025.