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

NCT06525363 | Completed Phase 1

• 1 other identifier: Dental 2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• Levels of oral Streptococcus mutans

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

  each 3 weeks for 12 weeks

• Plaque Examination

  Plaque is recorded using the plaque index (PI)

  each 3 weeks for 12 weeks

• The inflammatory status of the gingiva

  recorded using the gingival index (GI)

  each 3 weeks for 12 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

chitosan nanoparticles spray 1% w/w twice daily

Drug: Chitosan

control group

NO INTERVENTION

normal healthy hygiene of mouth

Interventions

Chitosan DRUG

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

treatment group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Soad A. Mohamad

Minya, Select Region, 05673, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Chitosan

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of pharamcy practices, faculaty of pharmacy, Deraya University

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)