Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-01-05

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

All participants and assessors will be masked,the wil just deal with the randomized numbers.

except the care provider because the materials consistency before mixing is obvious in 2 of the 3 groups

Study Groups

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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

Group Type EXPERIMENTAL

Glass Ionomer

Intervention Type DRUG

Glass ionomer filling material would be modified accordingly or used as is

Chitosan Low Molecular Weight (20-200 Mpa.S)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Glass Ionomer

Intervention Type DRUG

Glass ionomer filling material would be modified accordingly or used as is

Chitosan Low Molecular Weight (20-200 Mpa.S)

Intervention Type DRUG

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

Titanium Dioxide

Intervention Type DRUG

Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), \>99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332

Chlorhexidine glass ionomer

Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v

Group Type ACTIVE_COMPARATOR

Glass Ionomer

Intervention Type DRUG

Glass ionomer filling material would be modified accordingly or used as is

Chlorhexidine Diacetate

Intervention Type DRUG

Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716

Glass ionomer

Stock powder and liquid Fuji IX from GC japan

Group Type PLACEBO_COMPARATOR

Glass Ionomer

Intervention Type DRUG

Glass ionomer filling material would be modified accordingly or used as is

Interventions

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Glass Ionomer

Glass ionomer filling material would be modified accordingly or used as is

Intervention Type DRUG

Chitosan Low Molecular Weight (20-200 Mpa.S)

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

Intervention Type DRUG

Chlorhexidine Diacetate

Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716

Intervention Type DRUG

Titanium Dioxide

Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), \>99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332

Intervention Type DRUG

Other Intervention Names

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Fuji IX Aldrich, cat#448869, lot #STBG9041 chlorhexidine acetate Titanium(IV) oxide

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes