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Not yet recruiting NCT07291830

A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

No phase Interventional White Spot Lesions Enamel Demineralization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remineralizing self-etch primer (M-SEP, SEP 1), Standard self-etch primer (P-SEP, SEP 2).
Who it may be relevant to
Registry conditions: White Spot Lesions, Enamel Demineralization. Basic parameters: 12 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial

Overview

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

  • Device 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.
  • Device 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.

Primary outcome measures

  • Bracket Bond Failure Rate [Time frame: 6 MONTH]
Secondary outcome measures (1)
  • Adhesive Remnant Index [Time frame: 6 MONTH]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Iraq · 1 center
  • College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic — Baghdad

Publications

  • 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. PMID 34725354
  • 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. PMID 36322155

Identifiers

NCT: NCT07291830 · 1102425

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗