A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

ConditionsWhite Spot Lesions Enamel Demineralization

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

45 Participants

are divided into 2 treatment groups

Group A: Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LRExperimental treatment 2 interventions

Group B: Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Bracket Bond Failure Rate

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

Secondary outcomes

Adhesive Remnant Index

Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode

Time frame

6 MONTH

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov

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