Periodontal PocketPhase 2NCT06982248
The Proposed Study Aims to Investigate the Efficacy of Quercetin as an Adjunctive to Mechanical Debridement in Treatment of Periodontitis
A Phase 2 study testing NSP and chitosan nanoparticles gel loaded by quercetin, NSP and chitosan nanoparticles gel and scaling and root planning in people with Periodontal Pocket, run by Mansoura University at 1 site in Egypt.
Trial summary
the proposed study aims to investigate the effect of Quercetin in treatment of periodontitis patients Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- NSP and chitosan nanoparticles gel loaded by quercetin, NSP and chitosan nanoparticles gel and scaling and root planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 1 Jun 2025
- Phase
- Phase 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both sexes with an age ranging between 25 and 55 years will be included in the study. Patients diagnosed as having periodontitis based on clinical and radiographic examinations will be included
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
- Patients with sensitivity to the medication used in the study
- patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study will be excluded from the study.
- Additionally, patients with systemic diseases, smokers, pregnant and lactating patients, and patients not compliant with oral hygiene procedures will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Quercetin Loaded on Chitosan Nanoparticles Gel as an Adjunctive to Mechanical Debridement in Treatment of Periodontitis: Randomized Controlled Clinical Trial
the proposed study aims to investigate the effect of Quercetin in treatment of periodontitis patients
Read the detailed description
the proposed study aims to investigate the effect of Quercetin in treatment of periodontitis patients not having systemic diseases.the 2ry aim of study to estimate the neacular factor kabba B level in gingival crevicular fluids.
- Conditions
- Periodontal Pocket
- Being tested
- NSP and chitosan nanoparticles gel loaded by quercetin, NSP and chitosan nanoparticles gel, scaling and root planning
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSP and chitosan nanoparticles gel loaded by quercetinDrug
NSP and chitosan nanoparticles gel loaded by quercetin
NSP and chitosan nanoparticles gelDrug
NSP and chitosan nanoparticles gel
scaling and root planningProcedure or surgery
NSPT
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin | Experimental | selected patients receive SRP and chitosan nanoparticles gel loaded by quercetin Receives: Drug: NSP and chitosan nanoparticles gel loaded by quercetin |
| Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel. | Experimental | selected patients receive SRP and chitosan nanoparticles gel Receives: Drug: NSP and chitosan nanoparticles gel |
| Group 3: Periodontitis patients treated by NSPT only | Active comparator | NSPT Receives: Procedure: scaling and root planning |
| Group 4: Periodontally healthy subjects. | No intervention | healthy individual act as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment clinical attachment level by UNC 15 periodontal probe
Measured: 12 weeks
Secondary outcomes (1)
assessment of the gingival crevicular levels of NF-κB by Elisa kit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start15 Aug 2024
- Primary completion1 Feb 2025
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by Mansoura 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin. Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel. Group 3: Periodontitis patients treated by NSPT only. Group 4: Periodontally healthy subjects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jilan mohamed, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982248
- Sponsor's protocol ID
- A03030240H
- Status last verified
- May 2025
- First submitted
- 11 Dec 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Clinical effect of Quercetin in treatment of periodiontal pocket
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Quercetin Loaded on Chitosan Nanoparticles Gel as an Adjunctive to Mechanical Debridement in Treatment of Periodontitis: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06982248
- Acronym / sponsor ID
- A03030240H
- Conditions
- Periodontal Pocket
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 May 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 proposed study aims to investigate the effect of Quercetin in treatment of periodontitis patients
Detailed description
the proposed study aims to investigate the effect of Quercetin in treatment of periodontitis patients not having systemic diseases.the 2ry aim of study to estimate the neacular factor kabba B level in gingival crevicular fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin. Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel. Group 3: Periodontitis patients treated by NSPT only. Group 4: Periodontally healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin | Experimental | Drug: NSP and chitosan nanoparticles gel loaded by quercetinselected patients receive SRP and chitosan nanoparticles gel loaded by quercetin |
| Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel. | Experimental | Drug: NSP and chitosan nanoparticles gelselected patients receive SRP and chitosan nanoparticles gel |
| Group 3: Periodontitis patients treated by NSPT only | Active comparator | Procedure: scaling and root planningNSPT |
| Group 4: Periodontally healthy subjects. | No intervention | –healthy individual act as control group |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of both sexes with an age ranging between 25 and 55 years will be included in the study. Patients diagnosed as having periodontitis based on clinical and radiographic examinations will be included
Key exclusion criteria (5 listed)
- Insulin dependent diabetes
- Thyroid disease
- Patients with sensitivity to the medication used in the study
- patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study will be excluded from the study.
- Additionally, patients with systemic diseases, smokers, pregnant and lactating patients, and patients not compliant with oral hygiene procedures will also be excluded
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 |
|---|---|---|
| NSP and chitosan nanoparticles gel loaded by quercetinNSP and chitosan nanoparticles gel loaded by quercetin | Drug | Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin |
| NSP and chitosan nanoparticles gelNSP and chitosan nanoparticles gel | Drug | Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel. |
| scaling and root planningNSPT | Procedure or surgery | Group 3: Periodontitis patients treated by NSPT only |
Primary outcome
assessment clinical attachment level by UNC 15 periodontal probe
Time frame: 12 weeks
1 secondary outcome
assessment of the gingival crevicular levels of NF-κB by Elisa kit
Time frame: 12 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 21 May 2025.
- Individual participant dataSharing planned: Undecided. Clinical effect of Quercetin in treatment of periodiontal pocket
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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.
Jilan mohamed study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NSP and chitosan nanoparticles gel loaded by quercetin, NSP and chitosan nanoparticles gel and scaling and root planning in people with Periodontal Pocket, run by Mansoura 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 1 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: under way, not looking for participants, as of the sponsor's last update on 21 May 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.
What does this phase mean?
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?
assessment clinical attachment level by UNC 15 periodontal probe (time frame: 12 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 21 May 2025.