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Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Primary Purpose

Reversible Pulpitis, Pulpitis, Caries,Dental

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Glass Ionomer

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

Chlorhexidine Diacetate

Titanium Dioxide

About this trial

This is an interventional treatment trial for Reversible Pulpitis focused on measuring Glass ionomer, Chitosan, Titanium dioxide, Titanium dioxide nanoparticles, Chlorhexidine, indirect pulp capping, Alternative restorative technique, stepwise caries excavation, antibacterial restorative, incomplete caries removal, primary molars, early childhood caries

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts 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.

Sites / Locations

Faculty of Dentistry, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Chitosan Glass ionomer

Chitosan/Titanium dioxide nanoparticles Glass ionomer

Chlorhexidine glass ionomer

Glass ionomer

Arm 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

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

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

Stock powder and liquid Fuji IX from GC japan

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04365270

First Posted

December 6, 2019

Last Updated

January 11, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04365270

Brief Title

Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 15, 2019 (Actual)

Primary Completion Date

January 5, 2021 (Actual)

Study Completion Date

January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Glass ionomer, Chitosan, Titanium dioxide, Titanium dioxide nanoparticles, Chlorhexidine, indirect pulp capping, Alternative restorative technique, stepwise caries excavation, antibacterial restorative, incomplete caries removal, primary molars, early childhood caries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

All participants and assessors will be masked,the wil just deal with the randomized numbers. except the care provider because the materials consistency before mixing is obvious in 2 of the 3 groups

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chitosan Glass ionomer

Arm Type

Experimental

Arm Description

Arm Title

Chitosan/Titanium dioxide nanoparticles Glass ionomer

Arm Type

Experimental

Arm Description

Arm Title

Chlorhexidine glass ionomer

Arm Type

Active Comparator

Arm Description

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

Arm Title

Glass ionomer

Arm Type

Placebo Comparator

Arm Description

Stock powder and liquid Fuji IX from GC japan

Intervention Type

Drug

Intervention Name(s)

Glass Ionomer

Other Intervention Name(s)

Fuji IX

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Aldrich, cat#448869, lot #STBG9041

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine Diacetate

Other Intervention Name(s)

chlorhexidine acetate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Titanium Dioxide

Other Intervention Name(s)

Titanium(IV) oxide

Intervention Description

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

Primary Outcome Measure Information:

Title

Antibacterial

Description

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

Title

Clinical performance

Description

Time Frame

followup 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariem Wassel, Assistant professor

Organizational Affiliation

Ainshams University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Noha Kabil, Professor

Organizational Affiliation

Ainshams university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

omar A Hodhod, Dentist

Organizational Affiliation

British University in cairo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry, Ain Shams University

City

Cairo

ZIP/Postal Code

1156

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31686917

Citation

Mulder R, Anderson-Small C. Ion release of chitosan and nanodiamond modified glass ionomer restorative cements. Clin Cosmet Investig Dent. 2019 Sep 6;11:313-320. doi: 10.2147/CCIDE.S220089. eCollection 2019.

Results Reference

background

PubMed Identifier

28560054

Citation

Wassel MO, Khattab MA. Antibacterial activity against Streptococcus mutans and inhibition of bacterial induced enamel demineralization of propolis, miswak, and chitosan nanoparticles based dental varnishes. J Adv Res. 2017 Jul;8(4):387-392. doi: 10.1016/j.jare.2017.05.006. Epub 2017 May 17.

Results Reference

background

PubMed Identifier

28190299

Citation

Ibrahim MA, Meera Priyadarshini B, Neo J, Fawzy AS. Characterization of Chitosan/TiO2 Nano-Powder Modified Glass-Ionomer Cement for Restorative Dental Applications. J Esthet Restor Dent. 2017 Apr;29(2):146-156. doi: 10.1111/jerd.12282. Epub 2017 Feb 12.

Results Reference

result

PubMed Identifier

26079388

Citation

Ibrahim MA, Neo J, Esguerra RJ, Fawzy AS. Characterization of antibacterial and adhesion properties of chitosan-modified glass ionomer cement. J Biomater Appl. 2015 Oct;30(4):409-19. doi: 10.1177/0885328215589672. Epub 2015 Jun 15.

Results Reference

result

PubMed Identifier

27766712

Citation

Kabil NS, Badran AS, Wassel MO. Effect of the addition of chlorhexidine and miswak extract on the clinical performance and antibacterial properties of conventional glass ionomer: an in vivo study. Int J Paediatr Dent. 2017 Sep;27(5):380-387. doi: 10.1111/ipd.12273. Epub 2016 Oct 21.

Results Reference

result

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Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

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