A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding

NCT07291830 | Not Yet Recruiting

• 1 other identifier: 1102425
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Spot Lesions; Enamel Demineralization

Keywords

Orthodontic Bracket Bonding; Self-Etch Primers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adhesive Remnant Index

  6 MONTH

Study Arms (2)

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.

Device: Remineralizing self-etch primer (M-SEP, SEP 1); Device: Standard self-etch primer (P-SEP, SEP 2)

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.

Device: Remineralizing self-etch primer (M-SEP, SEP 1); Device: Standard self-etch primer (P-SEP, SEP 2)

Interventions

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.

Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL; Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR

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.

Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL; Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants unable to give informed consent,
• Had craniofacial anomalies,
• Require orthognathic surgery as part of their treatment,
• Had congenital enamel defects.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

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

Baghdad, Baghdad Governorate, 1417, Iraq

Location

Related Publications (2)

• 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 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.

  PMID: 36322155 BACKGROUND

Central Study Contacts

DIYAR TAHER AGHA, MSc Candidate

CONTACT

009647705880686; aghadiyar@gmail.com

Ali I Ibrahim, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: multi-center, parallel-group, single-blinded randomized clinical trial conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for orthodontic research.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)