Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

NCT04365270 | Completed Phase 3 DMC

• 1 other identifier: FDASU-REC IM 011730
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  followup 9 months

Study Arms (4)

Chitosan Glass ionomer

EXPERIMENTAL

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

Chitosan/Titanium dioxide nanoparticles Glass ionomer

EXPERIMENTAL

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; Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: Titanium Dioxide

Chlorhexidine glass ionomer

ACTIVE COMPARATOR

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

Drug: Glass Ionomer; Drug: Chlorhexidine Diacetate

Glass ionomer

PLACEBO COMPARATOR

Stock powder and liquid Fuji IX from GC japan

Drug: Glass Ionomer

Interventions

Glass Ionomer DRUG

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

Also known as: Fuji IX

Chitosan Glass ionomer; Chitosan/Titanium dioxide nanoparticles Glass ionomer; Chlorhexidine glass ionomer; Glass ionomer

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

Also known as: Aldrich, cat#448869, lot #STBG9041

Chitosan Glass ionomer; Chitosan/Titanium dioxide nanoparticles Glass ionomer

Chlorhexidine Diacetate DRUG

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

Also known as: chlorhexidine acetate

Chlorhexidine glass ionomer

Titanium Dioxide DRUG

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

Also known as: Titanium(IV) oxide

Chitosan/Titanium dioxide nanoparticles Glass ionomer

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 1156, Egypt

Location

Related Publications (5)

• 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.

  PMID: 31686917 BACKGROUND

• 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.

  PMID: 28560054 BACKGROUND

• 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.

  PMID: 28190299 RESULT

• 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.

  PMID: 26079388 RESULT

• 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.

  PMID: 27766712 RESULT

MeSH Terms

Conditions

Pulpitis; Dental Caries

Interventions

glass ionomer; fuji IX; Chlorhexidine; titanium dioxide

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mariem Wassel, Assistant professor

  Ainshams University

  STUDY CHAIR

• Noha Kabil, Professor

  Ainshams university

  STUDY DIRECTOR

• omar A Hodhod, Dentist

  British University in cairo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Teaching Assistant ,Dentist

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: April 28, 2020
• Study Start: January 15, 2019
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)