A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical 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.

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;

1. Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy.
2. Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography.
3. Measuring the total time required for remnant adhesive removal post bracket failure/debonding.
4. Evaluating patient perception during bracket failure/debonding and subsequent adhesive removal procedure.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participants unable to give informed consent,
• Had craniofacial anomalies,
• Require orthognathic surgery as part of their treatment,
• Had congenital enamel defects.