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

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 Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Chitosan

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Select Region
    • Minya, Select Region, Egypt, 05673
      • Soad A. Mohamad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; chitosan nanoparticles spray 1% w/w twice daily	Drug: Chitosan; chitosan nanoparticles 1%w/w will be formulated in form of spray for oral application twice daily
No Intervention: control group; normal healthy hygiene of mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Deraya University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Chelating Agents; Sequestering Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Chitosan
• Other Study ID Numbers: Dental 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No