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CompletedNCT06525363Updated Jun 26, 2025

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

A Phase 1 interventional study of Chitosan in Periodontal Diseases, sponsored by Deraya University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Deraya University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Diseases

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Deraya University is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients treated with other medication
  • Patients not diagnosed as asthmatic
  • Comorbidity
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    treatment group

    chitosan nanoparticles spray 1% w/w twice daily

    Drug: Chitosan

  • No intervention
    control group

    normal healthy hygiene of mouth

Interventions

  • DrugChitosan

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

06

What researchers measure

Primary outcomes

  1. Levels of oral Streptococcus mutans

    counting number of of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs)

    Time frame: each 3 weeks for 12 weeks

  2. Plaque Examination

    Plaque is recorded using the plaque index (PI)

    Time frame: each 3 weeks for 12 weeks

  3. The inflammatory status of the gingiva

    recorded using the gingival index (GI)

    Time frame: each 3 weeks for 12 weeks

07

Study locations

1 site
  • Soad A. Mohamad
    Minya, Select Region 05673, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06525363
Lead sponsor
Deraya University
Responsible party
Soad Ali (associate professor of pharamcy practices, faculaty of pharmacy, Deraya University, Deraya University) — Principal investigator
First posted
Jul 29, 2024
Start date
Aug 1, 2024
Primary completion
Feb 1, 2025
Completion
Mar 1, 2025
Last update
Jun 26, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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