A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

University of Baghdad

Status: Not yet enrolling

Conditions: Enamel Demineralization; White Spot Lesions

Treatments: Device: Standard self-etch primer (P-SEP, SEP 2); Device: Remineralizing self-etch primer (M-SEP, SEP 1)

Study type: Interventional

Funder types: Other

Identifiers

NCT07291830

1102425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 12 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR

Experimental group

Description:

Patients receive fixed MBT stainless-steel brackets bonded with two self-etch primers in a split-mouth design. Maxillary right and mandibular left incisors, canines, and premolars are etched with SEP 1; maxillary left and mandibular right counterparts are etched with SEP 2. All teeth are polished with fluoride-free pumice, brackets bonded with Transbond XT, and standard NiTi-stainless-steel archwire sequence used in both arches.

Treatment:

Device: Remineralizing self-etch primer (M-SEP, SEP 1)

Device: Standard self-etch primer (P-SEP, SEP 2)

Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL

Experimental group

Description:

Patients receive the same fixed MBT stainless-steel appliance and archwire sequence as Group A. In this arm, maxillary left and mandibular right incisors, canines, and premolars are etched with SEP 1, while maxillary right and mandibular left counterparts are etched with SEP 2. Bonding follows identical polishing, priming, Transbond XT application, and LED light-curing protocol as in Group A.

Treatment:

Device: Remineralizing self-etch primer (M-SEP, SEP 1)

Device: Standard self-etch primer (P-SEP, SEP 2)