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The Omission of Pumice Prophylaxis on Bracket Failure Rates Using Self Etch Primers

NCT04131855 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-10-21

No results posted yet for this study

Summary

The aim of the study is to investigate the role of pumice prophylaxis in the self etch primer method on clinical bond strengths. The relevance is that removal of the pumicing step in the SEP method could potentially save time \& cost for clinicians, and decrease discomfort for patients if it does not affect bond strengths.

The null hypothesis that will be tested is that pumice prophylaxis does not affect orthodontic bracket failure rates when used with the self etch primer. The alternative hypothesis is that there are less orthodontic bracket failures in the pumiced group while using the self etch primer.

Conditions

  • Orthodontic Appliance Complication

Interventions

OTHER

Pumice prophylaxis

Pumicing the teeth is the recommended prophylaxis to be used prior to the application of the self etch primer by the manufacturer - 3M Unitek Transbond Plus Self Etch Primer which will be used in the experiment.

OTHER

No pumice prophylaxis

Pumice prophylaxis will not be used as per manufacturers instructions.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Dr Kaminii Thevadass, BDS · Department of Paediatric Dentistry and Orthodontics,University of Malaya.

  • Prof Dr Siti Adibah Othman, BDS · Department of Paediatric Dentistry and Orthodontics,University of Malaya.

  • Dr Nor Nadia Zakaria, BDS · Department of Paediatric Dentistry and Orthodontics,University of Malaya.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-02-01
Completion
2021-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131855 on ClinicalTrials.gov