A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-35
SponsorUniversity of Baghdad

About this trial

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.

Eligibility criteria

Qualifiers

Full permanent dentition including incisors, canines, premolars, and molars (excepting 3rd molars;

Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide,

No previous orthodontic treatment with fixed appliances.

Disqualifiers

Participants unable to give informed consent,

Had craniofacial anomalies,

Require orthognathic surgery as part of their treatment,

Had congenital enamel defects.

Trial design

Treatments tested in this trial

  • Remineralizing self-etch primer (M-SEP, SEP 1)
  • Standard self-etch primer (P-SEP, SEP 2)

Treatment groups

45 Participants
are divided into 2 treatment groups

Sponsors and collaborators