Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets

NCT07355322 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Montpellier

Phase

Not applicable

Started

2026-01

Last updated

2026-01-21

Condition(s) studied

Tooth DemineralizationWhite Spot LesionDemineralizationOrthodontic Appliance ComplicationDental Braces Complication

Investigational drug(s) / intervention(s)

Transbond™ XT bonding procedureGC Ortho Connect™ bonding procedure

Transbond™ XT bonding procedure: Brackets are bonded to one hemi-arch using the 3-step protocol: 1) acid etching, 2) primer application, 3) adhesive placement and light curing.

GC Ortho Connect™ bonding procedure: Brackets are bonded to the contralateral hemi-arch using the 2-step protocol: 1) acid etching, 2) adhesive with integrated primer, followed by light curing.

Study summary

White spot lesions (WSLs) are one of the most common adverse effects of fixed orthodontic treatments, affecting up to 97% of patients treated with labial appliances. These early enamel demineralizations, caused by microleakage between enamel and adhesive, can appear as early as the fourth week of treatment. They not only pose aesthetic concerns but also increase the risk of bracket failure.

This randomized split-mouth clinical trial compares two bonding systems : the traditional three-step system (Transbond™ XT) and the simplified two-step system (GC Ortho Connect™) to assess their impact on enamel demineralization around orthodontic brackets. The degree of demineralization will be measured using the Enamel Decalcification Index (EDI) based on intraoral photographs and confirmed with a fluorescence camera (C50 Acteon).

The aim of the study is to determine whether the simplified bonding protocol can reduce clinical time and saliva contamination risk without increasing enamel demineralization, thus offering a potentially more efficient and conservative approach for orthodontic bonding procedures.

Eligibility

Sex

ALL

Min age

10 Years

Max age

16 Years

Healthy volunteers

Inclusion Criteria: * Patient aged 10 to 16 years included, * Patient attending their first dentofacial orthopedics consultation at the Montpellier Dental Care Center, in adolescent or young adult dentition (according to Démogé classification), * Patient requiring the placement of a bimaxillary multi-bracket treatment and opting for a metallic vestibular technique. Exclusion Criteria: * Syndromic patient (all syndromes included, e.g., cleft lip) or with a severe long-term condition (ALD), * Patient previously treated with a multi-bracket orthodontic treatment using a mixed, lingual, or vestibular technique, * Any medical condition deemed incompatible with bracket placement by the investigator, * Patient with severe MIH (molar-incisor hypomineralization) and/or severe demineralization on one or more teeth (including severe amelogenesis imperfecta or dentinogenesis imperfecta), * Patient with restorations such as metal crowns, ceramic crowns, porcelain-fused-to-metal crowns, inlays, onlays, or amalgam on one or more vestibular surfaces, * Patient with oral hygiene incompatible with orthodontic treatment, * Agenesis of lateral incisors, * Subject already participating in another interventional clinical trial that could interfere with this study, * Uncontrolled psychiatric disorder, * Lack of written informed consent from a legal representative after a reflection period, * Lack of cooperation or difficulty in communication/comprehension, or refusal of participation by the minor, * Subject with a dependency or employment relationship with the sponsor or investigator, * Subject participating in another research study with an ongoing exclusion period, * Subject not affiliated with the French social security system or not a beneficiary of such a system, * Protected populations according to the French Public Health Code: Pregnant or breastfeeding women Subjects deprived of liberty (by judicial, administrative decision, or involuntary hospitalization) Subjects under guardianship or curatorship

Primary outcome measure(s)

Mean Enamel Decalcification Index (EDI) after Debonding — Up to 24 months
Mean Enamel Decalcification Index (EDI) per maxillary hemi-arch after debonding of fixed orthodontic appliances. The assessment will be performed using intraoral photographs, based on the 0-3 scoring system of the Enamel Decalcification Index (EDI) by Banks \& Richmond, 1994, evaluating white spot lesions (WSLs) around maxillary metallic orthodontic brackets (AO groove .022 x .028). Results will be confirmed using a fluorescence intraoral camera.

Trial sites (1)

Facility	City	Region	Status
University Hospital Montpellier	Montpellier	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07355322 on ClinicalTrials.gov ↗ ← All trials in France