NCT07291830

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• White Spot Lesions
• Enamel Demineralization

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2025-12-18
• Last updated: 2026-01-05

Locations

1 site across 1 country: Iraq