A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond
NCT ID: NCT05345379
Last Updated: 2022-04-25
Study Results
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Basic Information
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UNKNOWN
NA
33 participants
INTERVENTIONAL
2022-04-11
2022-12-31
Brief Summary
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Detailed Description
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Without drying, one coat of the patient own non-stimulated saliva will be applied to the etched and wet surface using bond brush; the excess will be blotted with a moist cotton pellet maintaining the surface moist.
A liberal coat of the MIP will be applied to the etched area of the teeth destined for a specific primer (split-mouth) using a nylon bond brush. Air will be gently blown on each tooth for 2sec, aiming the air stream perpendicular to the enamel surface then light cured for 20sec. After etching and priming, molar tubes will be bonded to the teeth with a light-cured adhesive according to the manufacturer's instructions.
Initial wires will be fitted 10-15mins after bonding completion in the context of the straight wire technique.
All patients will receive the same instructions and will be seen at 3-4-week intervals. They will be, however, requested to inform the operator immediately and attend as soon as possible once a bond failure was apparent. the molar tubes bond survival will be followed up for 6 months. They will be instructed to brush with a manual toothbrush using a fluoride-containing toothpaste.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
QUADRUPLE
Study Groups
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Transbond MIP
Transbond primer group will be randomly allocated using a split-mouth, cross-quadrant design and two diagonal quadrants (i.e. upper right and lower left, or vice versa) for each participant.
Single intervention
Single intervention at the day of fixed orthodontic appliance bonding
Assure plus
Assure Plus primer group will be randomly allocated using a split-mouth, cross-quadrant design and two diagonal quadrants (i.e. upper right and lower left, or vice versa) for each participant.
Single intervention
Single intervention at the day of fixed orthodontic appliance bonding
Interventions
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Single intervention
Single intervention at the day of fixed orthodontic appliance bonding
Eligibility Criteria
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Inclusion Criteria
* Complete set of permanent dentition with fully erupted molar teeth on both arches;
* Intact 1st molars and mainly their buccal surfaces are free from caries, fillings, or gingival hyperplasia;
Exclusion Criteria
* Patients exhibit parafunctional habits;
* Patients who their treatment plan need appliance that soldered on molar bands.
* No occlusal interferences that can affect the ideal position of molar tubes, especially in the lower arch.
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Ahmed Abdulelah Abduljawad
orthodontics master student
Principal Investigators
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Harraa S Abdulameer, B.D.S, PhD
Role: STUDY_DIRECTOR
Baghdad college of dentistry, Department of orthodontics
Ahmed A Abduljawad, B.D.S
Role: PRINCIPAL_INVESTIGATOR
Baghdad college of dentistry, Department of orthodontics
Locations
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Baghdad college of dentistry
Baghdad, , Iraq
Countries
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Central Contacts
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Facility Contacts
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References
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Zeppieri IL, Chung CH, Mante FK. Effect of saliva on shear bond strength of an orthodontic adhesive used with moisture-insensitive and self-etching primers. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):414-9. doi: 10.1016/s0889-5406(03)00405-0.
Endo T, Ozoe R, Sanpei S, Shinkai K, Katoh Y, Shimooka S. Effects of moisture conditions of dental enamel surface on bond strength of brackets bonded with moisture-insensitive primer adhesive system. Odontology. 2008 Jul;96(1):50-4. doi: 10.1007/s10266-007-0083-7. Epub 2008 Jul 27.
Goswami A, Mitali B, Roy B. Shear bond strength comparison of moisture-insensitive primer and self-etching primer. J Orthod Sci. 2014 Jul;3(3):89-93. doi: 10.4103/2278-0203.137695.
Paschos E, Westphal JO, Ilie N, Huth KC, Hickel R, Rudzki-Janson I. Artificial saliva contamination effects on bond strength of self-etching primers. Angle Orthod. 2008 Jul;78(4):716-21. doi: 10.2319/0003-3219(2008)078[0716:ASCEOB]2.0.CO;2.
Roelofs T, Merkens N, Roelofs J, Bronkhorst E, Breuning H. A retrospective survey of the causes of bracket- and tube-bonding failures. Angle Orthod. 2017 Jan;87(1):111-117. doi: 10.2319/021616-136.1. Epub 2016 Jun 15.
Hadrous R, Bouserhal J, Osman E. Evaluation of shear bond strength of orthodontic molar tubes bonded using hydrophilic primers: An in vitro study. Int Orthod. 2019 Sep;17(3):461-468. doi: 10.1016/j.ortho.2019.06.006. Epub 2019 Jul 2.
Gange P. The evolution of bonding in orthodontics. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S56-63. doi: 10.1016/j.ajodo.2015.01.011.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Transbond MIP product page
Assure plus product page
Other Identifiers
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594422
Identifier Type: -
Identifier Source: org_study_id
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