Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Antimicrobial Activity and Clinical Performance of Chitosan-modified Glass Ionomer: A Randomized Clinical Trial

Conditions
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Reversible Pulpitis, Pulpitis, Caries,Dental, Caries Class I, Caries; Dentin, Caries

Intervention / Treatment
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* Drug: Glass Ionomer
* Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)
* Drug: Chlorhexidine Diacetate
* Drug: Titanium Dioxide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitosan Glass ionomer<br>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 | Drug: Glass Ionomer<br>* Glass ionomer filling material would be modified accordingly or used as is<br>* Other names: Fuji IX;Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)<br>* deacetylated chitin, poly(D-glucosamine) purified by dissolving in 0.1 mol/L acetic acid, then precipitated in 0.1 mol/L sodium hydroxide and the precipitate will be washed with ethanol/water (70/30 v/v) mixture followed by freeze drying<br>* Other names: Aldrich, cat#448869, lot #STBG9041;|
| Experimental: Chitosan/Titanium dioxide nanoparticles Glass ionomer<br>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 | Drug: Glass Ionomer<br>* Glass ionomer filling material would be modified accordingly or used as is<br>* Other names: Fuji IX;Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)<br>* deacetylated chitin, poly(D-glucosamine) purified by dissolving in 0.1 mol/L acetic acid, then precipitated in 0.1 mol/L sodium hydroxide and the precipitate will be washed with ethanol/water (70/30 v/v) mixture followed by freeze drying<br>* Other names: Aldrich, cat#448869, lot #STBG9041;Drug: Titanium Dioxide<br>* Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), >99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332<br>* Other names: Titanium(IV) oxide;|
| Active Comparator: Chlorhexidine glass ionomer<br>Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v | Drug: Glass Ionomer<br>* Glass ionomer filling material would be modified accordingly or used as is<br>* Other names: Fuji IX;Drug: Chlorhexidine Diacetate<br>* Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716<br>* Other names: chlorhexidine acetate;|
| Placebo Comparator: Glass ionomer<br>Stock powder and liquid Fuji IX from GC japan | Drug: Glass Ionomer<br>* Glass ionomer filling material would be modified accordingly or used as is<br>* Other names: Fuji IX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibacterial | 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 | 9 months | 
| Clinical performance | 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. | followup 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glass ionomer, Chitosan, Titanium dioxide, Titanium dioxide nanoparticles, Chlorhexidine, indirect pulp capping, Alternative restorative technique, stepwise caries excavation, antibacterial restorative, incomplete caries removal, primary molars, early childhood caries