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Clinical Assessment of Chitosan Nanoparticles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial

Clinical Assessment of Chitosan Nano-particles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06525363
Enrollment
20
Registered
2024-07-29
Start date
2024-08-01
Completion date
2025-03-01
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

Brief 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 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.

Interventions

chitosan nanoparticles 1%w/w will be formulated in form of spray for oral application twice daily

Sponsors

Deraya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* Patients treated with other medication * Patients not diagnosed as asthmatic * Comorbidity

Design outcomes

Primary

MeasureTime frameDescription
Levels of oral Streptococcus mutanseach 3 weeks for 12 weekscounting number of of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs)
Plaque Examinationeach 3 weeks for 12 weeksPlaque is recorded using the plaque index (PI)
The inflammatory status of the gingivaeach 3 weeks for 12 weeksrecorded using the gingival index (GI)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026