The Omission of Pumice Prophylaxis on Bracket Failure Rates Using Self Etch Primers
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedOctober 21, 2019
October 1, 2019
1.3 years
October 17, 2019
October 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the bond failure rates between pumiced and non-pumiced teeth.
Done by calculating and comparing the percentage of bracket breakages between the pumiced and non-pumiced quadrants.
Data on bond failure will be collected at 1 month after placement of the 19x25 SS wire.
Secondary Outcomes (2)
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.
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.
Study Arms (2)
Pumice prophylaxis.
ACTIVE COMPARATORWill 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.
No pumice prophylaxis.
EXPERIMENTALWill not receive pumice prophylaxis. Teeth will be washed and dried before using the self etch primer.
Interventions
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.
Pumice prophylaxis will not be used as per manufacturers instructions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Burgess AM, Sherriff M, Ireland AJ. Self-etching primers: is prophylactic pumicing necessary? A randomized clinical trial. Angle Orthod. 2006 Jan;76(1):114-8. doi: 10.1043/0003-3219(2006)076[0114:SPIPPN]2.0.CO;2.
PMID: 16448279RESULTLill DJ, Lindauer SJ, Tufekci E, Shroff B. Importance of pumice prophylaxis for bonding with self-etch primer. Am J Orthod Dentofacial Orthop. 2008 Mar;133(3):423-6; quiz 476.e2. doi: 10.1016/j.ajodo.2006.03.039.
PMID: 18331943RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Kaminii Thevadass, BDS
Department of Paediatric Dentistry and Orthodontics,University of Malaya.
- STUDY DIRECTOR
Prof Dr Siti Adibah Othman, BDS
Department of Paediatric Dentistry and Orthodontics,University of Malaya.
- STUDY DIRECTOR
Dr Nor Nadia Zakaria, BDS
Department of Paediatric Dentistry and Orthodontics,University of Malaya.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 18, 2019
Study Start
November 1, 2019
Primary Completion
February 1, 2021
Study Completion
March 1, 2021
Last Updated
October 21, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
Consent has not yet been gained from participants as recruiting has not begun.