Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

January 11, 2021 updated by: Omar Assem Hodhod, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1156
        • Faculty of Dentistry, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Glass Ionomer
Glass ionomer filling material would be modified accordingly or used as is
Other Names:
  • Fuji IX
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
Other Names:
  • Aldrich, cat#448869, lot #STBG9041
Experimental: 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
Drug: Glass Ionomer
Glass ionomer filling material would be modified accordingly or used as is
Other Names:
  • Fuji IX
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
Other Names:
  • Aldrich, cat#448869, lot #STBG9041
Drug: Titanium Dioxide
Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), >99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332
Other Names:
  • Titanium(IV) oxide
Active Comparator: Chlorhexidine glass ionomer
Chlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
Drug: Glass Ionomer
Glass ionomer filling material would be modified accordingly or used as is
Other Names:
  • Fuji IX
Drug: Chlorhexidine Diacetate
Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716
Other Names:
  • chlorhexidine acetate
Placebo Comparator: Glass ionomer
Stock powder and liquid Fuji IX from GC japan
Drug: Glass Ionomer
Glass ionomer filling material would be modified accordingly or used as is
Other Names:
  • Fuji IX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibacterial
Time Frame: 9 months
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
Time Frame: followup 9 months

"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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Mariem Wassel, Assistant professor, Ainshams university
  • Study Director: Noha Kabil, Professor, Ainshams university
  • Principal Investigator: omar A Hodhod, Dentist, British University in cairo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

January 5, 2021

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-REC IM 011730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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