Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Phase 3

Completed

• Conditions: Reversible Pulpitis; Pulpitis; Caries,Dental; Caries Class I; Caries; Dentin; Caries
• Interventions: Drug: Glass Ionomer; Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: Chlorhexidine Diacetate; Drug: Titanium Dioxide

• Registration Number: NCT04365270
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Status Verified: 2021-01
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-05
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chitosan Glass ionomer	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
Chitosan Glass ionomer	Chitosan Low Molecular Weight (20-200 Mpa.S)	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
Chitosan/Titanium dioxide nanoparticles Glass ionomer	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
Chitosan/Titanium dioxide nanoparticles Glass ionomer	Chitosan Low Molecular Weight (20-200 Mpa.S)	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
Chlorhexidine glass ionomer	Glass Ionomer	Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
Chlorhexidine glass ionomer	Chlorhexidine Diacetate	Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
Glass ionomer	Glass Ionomer	Stock powder and liquid Fuji IX from GC japan
Chitosan/Titanium dioxide nanoparticles Glass ionomer	Titanium Dioxide	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

Primary Outcome Measures

Name	Time	Method
Antibacterial	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	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt