Clinical trial NCT04365270: 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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 65
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Antibacterial
timeFrame: 9 months
measure: Clinical performance
timeFrame: followup 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Ainshams University
name: Mariem Wassel, Assistant professor
role: STUDY_CHAIR
affiliation: Ainshams university
name: Noha Kabil, Professor
role: STUDY_DIRECTOR
affiliation: British University in cairo
name: omar A Hodhod, Dentist
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.