NCT04365270

Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Glass Ionomer	Glass ionomer filling material would be modified accordingly or used as is
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

Timeline

• Start date: 2019-01-15
• Primary completion: 2021-01-05
• Completion: 2021-01-05
• First posted: 2020-04-28
• Last updated: 2021-01-12

Locations

1 site across 1 country: Egypt