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Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

NCT04365270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-01-12

No results posted yet for this study

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

Conditions

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

Interventions

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

DRUG

Chlorhexidine Diacetate

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

DRUG

Titanium Dioxide

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

DRUG

Glass Ionomer

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mariem Wassel, Assistant professor · Ainshams University

  • Noha Kabil, Professor · Ainshams university

  • omar A Hodhod, Dentist · British University in cairo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2021-01-05
Completion
2021-01-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365270 on ClinicalTrials.gov