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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04131855
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Kaminii A/P Thevadass, University of Malaya

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.


Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Other: Pumice prophylaxis Other: No pumice prophylaxis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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: 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.
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.
Other Names:
  • Pumice slurry
  • Pumice powder

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients receiving fixed appliance therapy with only metal brackets on both upper and lower arches.
  2. Good oral hygiene.
  3. Balanced extractions in both upper and lower arches.
  4. Right-handed patients

Exclusion Criteria:

  1. Enamel defects, hypoplasia or buccal restorations that would preclude bonding to enamel.
  2. Orthognathic cases.
  3. Surgically exposed teeth or teeth where bracket placement will be delayed.
  4. Patients with craniofacial anomalies.
  5. Previous use of fixed appliances.
  6. Patients that will require partial ligation of teeth immediately after bond-up.

Information from the National Library of Medicine

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


Contacts
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Contact: Dr Kaminii Thevadass, BDS +60175811526 kaminiithevadass86@gmail.com
Contact: Dr Nor Nadia Zakaria, BDS +60122462303 nornadiazakaria@um.edu.my

Sponsors and Collaborators
University of Malaya
Investigators
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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.

Publications of Results:
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Responsible Party: Dr Kaminii A/P Thevadass, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT04131855    
Other Study ID Numbers: DF CD1909/0057(P)
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Consent has not yet been gained from participants as recruiting has not begun.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Kaminii A/P Thevadass, University of Malaya:
self etch primers
pumice
orthodontic bracket failure