The Antimicrobial Activity and Clinical Performance of Chitosan-modified Glass Ionomer: A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Glass Ionomer
- Conditions
- Reversible Pulpitis
- Sponsor
- Ain Shams University
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Antibacterial
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars
Detailed Description
Participants will be recruited from the acquitted to the clinic of pediatric dentistry department , Faculty of Dentistry of Ain Shams University. random allocation of the participants where indirect pulp capping is indicated so that modified Glass ionomer would be used as the filling material. partial removal of caries is done then caries sample would be taken and sent for a microbiological evaluation and then, cavity dimensions is recoded, finally placement of the modified glass ionomer in the prepared cavity. In a total period of 9 months the patients will be followed every 3 months for clinical evaluation and in the final visit the filling would be removed and another bacterial sample would be taken for comparison, then a permanent filling is placed.
Investigators
Omar Assem Hodhod
Principal Investigator,Teaching Assistant ,Dentist
British University In Egypt
Eligibility Criteria
Inclusion Criteria
- •The teeth will be primary molars selected from patients presented to the outpatient clinic that are
- •Healthy patients.
- •Age: 4-8 years.
- •Children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (Ø=0.9 mm).
Exclusion Criteria
- •Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
- •Children with systemic diseases.
- •Patients with history of active para-functional oral habits, xerostomia.
- •Patients who will have difficulties in cooperating.
Arms & Interventions
Glass ionomer
Stock powder and liquid Fuji IX from GC japan
Intervention: Glass Ionomer
Chitosan Glass ionomer
purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid to be used to modify the stock liquid provided with the glassionomer Fuji IX to have 10% v/v chitosan. will be placed in the prepared cavity over the last layer of caries
Intervention: Glass Ionomer
Chitosan Glass ionomer
purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid to be used to modify the stock liquid provided with the glassionomer Fuji IX to have 10% v/v chitosan. will be placed in the prepared cavity over the last layer of caries
Intervention: Chitosan Low Molecular Weight (20-200 Mpa.S)
Chitosan/Titanium dioxide nanoparticles Glass ionomer
The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid. The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
Intervention: Glass Ionomer
Chitosan/Titanium dioxide nanoparticles Glass ionomer
The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid. The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
Intervention: Chitosan Low Molecular Weight (20-200 Mpa.S)
Chitosan/Titanium dioxide nanoparticles Glass ionomer
The stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid. The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
Intervention: Titanium Dioxide
Chlorhexidine glass ionomer
Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
Intervention: Glass Ionomer
Chlorhexidine glass ionomer
Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
Intervention: Chlorhexidine Diacetate
Outcomes
Primary Outcomes
Antibacterial
Time Frame: 9 months
Dentin samples incubated on 2 culture mediums and total bacterial count by counting colony forming units will be counted. Higher number means Less antibacterial effect
Clinical performance
Time Frame: followup 9 months
"Modified United States Public Health Service Ryge Criteria" for Direct Clinical Evaluation and rating of Restoration.measuring color match, anatomic contour, marginal integrity, cavosurface marginal discoloration, secondary caries, surface texture, gross fracture. each outcome will be graded Alpha(A) for the highest score, Bravo(b) for moderate score, and Charlie(C) for the lowest score.