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A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding
Sponsor: University of Baghdad
Summary
This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Official title: Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
12 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-12-15
Completion Date
2026-12-30
Last Updated
2026-01-05
Healthy Volunteers
Yes
Interventions
Remineralizing self-etch primer (M-SEP, SEP 1)
Experimental self-etch primer based on Transbond Plus modified with 7% nano-hydroxyapatite. Applied to labial/buccal enamel of incisors, canines, and premolars after pumice prophylaxis; air-dried 3 s, brackets bonded with Transbond XT and LED light-cured 10 s mesial and 10 s distal.
Standard self-etch primer (P-SEP, SEP 2)
Conventional Transbond Plus self-etch primer used according to manufacturer's instructions for enamel conditioning of incisors, canines, and premolars, followed by Transbond XT adhesive and LED light-curing as above.
Locations (1)
College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic
Baghdad, Baghdad Governorate, Iraq