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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR | Experimental | 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. |
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| Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | 6 MONTH |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesive Remnant Index | Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode | 6 MONTH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DIYAR TAHER AGHA, MSc Candidate | Contact | 009647705880686 | aghadiyar@gmail.com | |
| Ali I Ibrahim, Professor | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic | Baghdad | Baghdad Governorate | 1417 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34725354 | Background | Erbe C, Hartmann L, Schmidtmann I, Ohlendorf D, Wehrbein H. A novel method quantifying caries following orthodontic treatment. Sci Rep. 2021 Nov 1;11(1):21347. doi: 10.1038/s41598-021-00561-7. | |
| 36322155 | Background | Garma NMH, Ibrahim AI. Development of a remineralizing calcium phosphate nanoparticle-containing self-etching system for orthodontic bonding. Clin Oral Investig. 2023 Apr;27(4):1483-1497. doi: 10.1007/s00784-022-04767-5. Epub 2022 Nov 2. |
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No IPD sharing is planned because patient consent and institutional policy do not allow external sharing of individual-level data."
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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.
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multi-center, parallel-group, single-blinded randomized clinical trial conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for orthodontic research.
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| 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. |
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