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Completed

NCT Number: NCT04365270

Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

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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Key information

Conditions

Reversible Pulpitis Caries Caries Class I Caries,Dental Caries; Dentin Dental Caries Dental Pulp Diseases Pulpitis Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, 1156, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glass Ionomer

Drug

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

Other names: Fuji IX

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

Other names: Aldrich, cat#448869, lot #STBG9041

Chlorhexidine Diacetate

Drug

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

Other names: chlorhexidine acetate

Titanium Dioxide

Drug

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

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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