Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Ain Shams University

Status and phase

Completed

Phase 3

Conditions

Caries Class I

Pulpitis

Caries,Dental

Reversible Pulpitis

Caries; Dentin

Caries

Treatments

Drug: Titanium Dioxide

Drug: Chlorhexidine Diacetate

Drug: Glass Ionomer

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04365270

FDASU-REC IM 011730

Details and patient eligibility

About

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

Full 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.

Enrollment

65 patients

Sex

All

Ages

4 to 8 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

65 participants in 4 patient groups, including a placebo group

Chitosan Glass ionomer

Experimental group

Description:

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

Treatment:

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

Drug: Glass Ionomer

Chitosan/Titanium dioxide nanoparticles Glass ionomer

Experimental group

Description:

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

Treatment:

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

Drug: Titanium Dioxide

Drug: Glass Ionomer

Chlorhexidine glass ionomer

Active Comparator group

Description:

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

Treatment:

Drug: Glass Ionomer

Drug: Chlorhexidine Diacetate

Glass ionomer