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Completed

NCT Number: NCT06525363

Clinical Assessment of Chitosan Nanoparticles 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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Soad A. Mohamad

Minya, Select Region, 05673, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chitosan

Drug

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

Primary outcomes

  1. 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)

  2. Plaque Examination

    Time frame: each 3 weeks for 12 weeks

    Plaque is recorded using the plaque index (PI)

  3. The inflammatory status of the gingiva

    Time frame: each 3 weeks for 12 weeks

    recorded using the gingival index (GI)

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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