The Omission of Pumice Prophylaxis on Bracket Failure Rates Using Self Etch Primers: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Malaya
- Enrollment
- 20
- Primary Endpoint
- To compare the bond failure rates between pumiced and non-pumiced teeth.
Study Overview
Brief 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.
Detailed Description
INTRODUCTION:
There is a clinically significant variation in individual understandings and approaches among orthodontists to pumicing prior to using the SEP to bond brackets. There is also a lack of current studies in the last decade comparing bond strengths between pumiced and non-pumiced teeth while using the latest SEP products in the market. Therefore the aim of this research is to the investigate the relevance of pumicing prior to bonding orthodontic brackets. The investigators also then aim to recommend either the continued usage of, or to highlight it's clinical redundancy in the bond-up process, hence reducing cost and saving time for both the patient and clinician.
SAMPLE SIZE CALCULATION:
Based on the expected proportions of bracket breakages in pumiced and non-pumiced groups, a one-tailed priori power calculation determined that 266 orthodontic brackets would be required to give a power of 0.9 at significance level of 0.05, assuming failure proportions of 2.46% and 11.41% (Lill, 2008), which was deemed a clinically significant difference.
Incorporating an attrition rate of 20%, the ideal sample size to achieve a statistically significant result would be 319 brackets, equivalent to 20 patients with 16 orthodontic brackets each.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
The procedures, data collection and data analysis will be done by the orthodontic post-graduate student who is the main investigator in this study, and will not be blinded.The patients will be blinded. This will be done by pumicing the occlusal surfaces of the teeth that are in the study quadrant, and the labial surfaces of the teeth in the control quadrant. The trial is hence a single-blinded study.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients receiving fixed appliance therapy with only metal brackets on both upper and lower arches.
- •Good oral hygiene.
- •Balanced extractions in both upper and lower arches.
- •Right-handed patients
Exclusion Criteria
- •Enamel defects, hypoplasia or buccal restorations that would preclude bonding to enamel.
- •Orthognathic cases.
- •Surgically exposed teeth or teeth where bracket placement will be delayed.
- •Patients with craniofacial anomalies.
- •Previous use of fixed appliances.
- •Patients that will require partial ligation of teeth immediately after bond-up.
Arms & Interventions
Pumice prophylaxis.
Will receive pumice prophylaxis in a slurry of plain pumice and water for 5 seconds per tooth using a rubber cup in a slow contra-angle handpiece. The teeth involved will then be washed and dried prior to using the self etch primer.
Intervention: Pumice prophylaxis (Other)
No pumice prophylaxis.
Will not receive pumice prophylaxis. Teeth will be washed and dried before using the self etch primer.
Intervention: No pumice prophylaxis (Other)
Outcomes
Primary Outcomes
To compare the bond failure rates between pumiced and non-pumiced teeth.
Time Frame: Data on bond failure will be collected at 1 month after placement of the 19x25 SS wire.
Done by calculating and comparing the percentage of bracket breakages between the pumiced and non-pumiced quadrants.
Secondary Outcomes
- To determine the interfaces at which the bond failures occur after bracket breakage.(Data on adhesive remnant will be collected from the tooth surface immediately after bracket breakage.)
- To compare the bracket breakage rates between anterior and posterior teeth.(Data on bond failure will be collected at 1 month after placement of the 19x25 SS wire.)
Investigators
Dr Kaminii A/P Thevadass
Principal Investigator
University of Malaya