The Omission of Pumice Prophylaxis on Bracket Failure Rates Using Self Etch Primers
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|ClinicalTrials.gov Identifier: NCT04131855|
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Orthodontic Appliance Complication||Other: Pumice prophylaxis Other: No pumice prophylaxis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be placed in two different groups based on the randomization and will receive, or not receive the intervention, which is pumicing prior to bond-up, for the duration of the study.|
|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.|
|Official Title:||The Omission of Pumice Prophylaxis on Bracket Failure Rates Using Self Etch Primers: A Randomized Controlled Clinical Trial|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Active Comparator: 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.
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.
Experimental: No pumice prophylaxis.
Will not receive pumice prophylaxis. Teeth will be washed and dried before using the self etch primer.
Other: No pumice prophylaxis
Pumice prophylaxis will not be used as per manufacturers instructions.
- 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.
- To compare the bracket breakage rates between anterior and posterior 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 in anterior and posterior teeth in both the groups.
- To determine the interfaces at which the bond failures occur after bracket breakage. [ Time Frame: Data on adhesive remnant will be collected from the tooth surface immediately after bracket breakage. ]Done by assessing the amount of adhesive remnant remaining on the tooth surface.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131855
|Contact: Dr Kaminii Thevadass, BDSemail@example.com|
|Contact: Dr Nor Nadia Zakaria, BDSfirstname.lastname@example.org|
|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.|