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Clinical Trials/CTRI/2023/11/060313
CTRI/2023/11/060313Not yet recruitingNot Applicable

Antibacterial efficacy of zinc oxide nanoparticle coated elastomeric modules- A Randomized Clinical trial

Dr. Hemashree J1 site in 1 country32 target enrollmentStarted: December 11, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
To evaluate

Study Overview

Brief Summary

Certain studies have evaluated the antibacterial efficacy of nanoparticle coated brackets and nanoparticle incorporated composite separately and studies have only evaluated the short term efficacy of nanoparticles on the  cariogenic bacterial in the plaque. No studies have compared the efficacy of  nanoparticle coated elastomeric modules over the uncoated modules.  Long term studies are required to evaluate whether the efficacy of nanoparticles extends to reduced incidence of white spot lesions. Therefore, this study was designed to compare the efficacy of noanoparticles coated on elastomeric modules on long term against streptococcus mutans concentration in plaque and on the incidence of white spot lesions.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
15.00 Year(s) to 30.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients undergoing orthodontic treatment Non- extraction fixed appliance cases Patients with good OHI.
  • Patients not taking medication Patients with no relevant medical history.
  • Patients with permanent dentition with full complement of teeth Patients with good gingival and periodontal health.

Exclusion Criteria

  • Patients with poor oral hygiene Patients with extensive dental caries Patients with no history of illness or allergies.
  • Patients with periodontitis and bone loss.

Outcomes

Primary Outcomes

To evaluate

Time Frame: End of 3 months and end of one year

streptococcus mutans concentration in plaque

Time Frame: End of 3 months and end of one year

using real-time

Time Frame: End of 3 months and end of one year

polymerase chain reaction (PCR) and white spot lesion formation

Time Frame: End of 3 months and end of one year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr. Hemashree J
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DrHemashree J

Sri Ramachandra Institute of Higher Education and Research

Study Sites (1)

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