Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Ain Shams University65 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

Glass IonomerDRUG

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

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

Chlorhexidine DiacetateDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: followup 9 months

Data from ClinicalTrials.gov

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