College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic
Baghdad, Baghdad Governorate, 1417, Iraq
Location contact
Ali I Ibrahim, Professor
CONTACT
Diyar Taher Agha, MSc Candidate
CONTACT
NCT Number: NCT07291830
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.
Trial opening soon.
Get Notified12 year–35 year
All sexes
Interventional
Not applicable
Baghdad, Baghdad Governorate, 1417, Iraq
Ali I Ibrahim, Professor
CONTACT
Diyar Taher Agha, MSc Candidate
CONTACT
To evaluate the clinical performance of a newly developed self-etch primer (M-SEP) versus P-SEP in bonding metallic orthodontic brackets to different teeth, verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Objectives:
Primary; Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.
Secondary;
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 MONTH
Documented as a percentage of brackets debonded during the 6-month observation period, categorized by location (incisor, canine, premolar) and cause (adhesive failure, cohesive failure, bracket fracture .
Time frame: 6 MONTH
Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode
Contact information is provided by the study sponsor or research team.
Ali I Ibrahim, Professor
CONTACT
DIYAR TAHER AGHA, MSc Candidate
CONTACT
University of Baghdad
Other
Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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