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NCT Number: NCT07291830

A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

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.

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Key information

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic

Baghdad, Baghdad Governorate, 1417, Iraq

Location contact

Ali I Ibrahim, Professor

CONTACT

Diyar Taher Agha, MSc Candidate

CONTACT

[email protected]

009647705880686

About this study

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;

  • Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy.
  • Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography.
  • Measuring the total time required for remnant adhesive removal post bracket failure/debonding.
  • Evaluating patient perception during bracket failure/debonding and subsequent adhesive removal procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Bracket Bond Failure Rate

    Time frame: 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 outcomes

  1. Adhesive Remnant Index

    Time frame: 6 MONTH

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ali I Ibrahim, Professor

CONTACT

DIYAR TAHER AGHA, MSc Candidate

CONTACT

[email protected]

009647705880686

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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