A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: White Spot Lesions; Enamel Demineralization
• Intervention / Treatment: Device: Remineralizing self-etch primer (M-SEP, SEP 1); Device: Standard self-etch primer (P-SEP, SEP 2)

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DIYAR TAHER AGHA, MSc Candidate; Phone Number: 009647705880686; Email: aghadiyar@gmail.com
• Study Contact Backup: Name: Ali I Ibrahim, Professor

Study Locations

• Iraq
  • Baghdad Governorate
    • Baghdad, Baghdad Governorate, Iraq, 1417
      • College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic
      • Contact: Ali I Ibrahim, Professor
      • Contact: Diyar Taher Agha, MSc Candidate; Phone Number: 009647705880686; Email: aghadiyar169@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesive Remnant Index	Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode	6 MONTH

Collaborators and Investigators

• Sponsor: University of Baghdad

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Orthodontic Bracket Bonding; Self-Etch Primers
• Other Study ID Numbers: 1102425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing is planned because patient consent and institutional policy do not allow external sharing of individual-level data."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No