Enamel Demineralization, White Spot Lesions
Conditions
Keywords
Orthodontic Bracket Bonding, Self-Etch Primers
Brief 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.
Interventions
DEVICEStandard 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.
DEVICERemineralizing 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.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
multi-center, parallel-group, single-blinded randomized clinical trial conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for orthodontic research.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bracket Bond Failure Rate | 6 MONTH | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adhesive Remnant Index | 6 MONTH | Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode |
Countries
Iraq
Contacts
CONTACTDIYAR TAHER AGHA, MSc Candidate
CONTACTAli I Ibrahim, Professor
Outcome results
None listed