A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding
NCT ID: NCT07291830
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2025-12-15
2026-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL
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.
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.
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.
Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Had craniofacial anomalies,
* Require orthognathic surgery as part of their treatment,
* Had congenital enamel defects.
12 Years
35 Years
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Ali I Ibrahim
Professor
Locations
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College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic
Baghdad, Baghdad Governorate, Iraq
Countries
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Central Contacts
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Ali I Ibrahim, Professor
Role: CONTACT
Facility Contacts
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Ali I Ibrahim, Professor
Role: backup
References
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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.
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.
Other Identifiers
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1102425
Identifier Type: -
Identifier Source: org_study_id
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