Periodontal DiseasesPhase 1NCT06525363
Clinical Assessment of Chitosan Nanoparticles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial
A Phase 1 study testing Chitosan in people with Periodontal Diseases, run by Deraya University at 1 site in Egypt.
Trial summary
Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Chitosan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Mar 2025
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 18-50 years old
- Both sex male and female
- Patients diagnosed as Asthmatic
- Patients treated with corticosteroids inhaler or ( beta2-adrenergic agonist inhaler or nebulizer for their symptoms)
Who cannot join
- Patients treated with other medication
- Patients not diagnosed as asthmatic
- Comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Chitosan Nano-particles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial
Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. The understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. Systemic antibiotics have been used in different forms of periodontal disease treatment. Systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. However, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at To evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.
- Conditions
- Periodontal Diseases
- Being tested
- Chitosan
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitosanDrug
chitosan nanoparticles 1%w/w will be formulated in form of spray for oral application twice daily
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | chitosan nanoparticles spray 1% w/w twice daily Receives: Drug: Chitosan |
| control group | No intervention | normal healthy hygiene of mouth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of oral Streptococcus mutans
counting number of of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs)
Measured: each 3 weeks for 12 weeks
Plaque Examination
Plaque is recorded using the plaque index (PI)
Measured: each 3 weeks for 12 weeks
The inflammatory status of the gingiva
recorded using the gingival index (GI)
Measured: each 3 weeks for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525363
- Sponsor's protocol ID
- Dental 2024
- Status last verified
- Jun 2025
- First submitted
- 24 Jul 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Chitosan Nano-particles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial
- ClinicalTrials.gov ID
- NCT06525363
- Acronym / sponsor ID
- Dental 2024
- Conditions
- Periodontal Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 29 Jul 2024 (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.
Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. The understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. Systemic antibiotics have been used in different forms of periodontal disease treatment. Systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. However, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at To evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Chitosanchitosan nanoparticles spray 1% w/w twice daily |
| control group | No intervention | –normal healthy hygiene of mouth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18-50 years old
- Both sex male and female
- Patients diagnosed as Asthmatic
- Patients treated with corticosteroids inhaler or ( beta2-adrenergic agonist inhaler or nebulizer for their symptoms)
Key exclusion criteria (3 listed)
- Patients treated with other medication
- Patients not diagnosed as asthmatic
- Comorbidity
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 |
|---|---|---|
| Chitosanchitosan nanoparticles 1%w/w will be formulated in form of spray for oral application twice daily | Drug | treatment group |
Primary outcome
Levels of oral Streptococcus mutans
Time frame: each 3 weeks for 12 weeks
counting number of of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs)
Plaque Examination
Time frame: each 3 weeks for 12 weeks
Plaque is recorded using the plaque index (PI)
The inflammatory status of the gingiva
Time frame: each 3 weeks for 12 weeks
recorded using the gingival index (GI)
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 26 Jun 2025.
- Individual participant dataSharing planned: No
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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 study testing Chitosan in people with Periodontal Diseases, run by Deraya 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 3 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 26 Jun 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Levels of oral Streptococcus mutans (time frame: each 3 weeks for 12 weeks). The study lists 3 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 26 Jun 2025.