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

Starting soon · Not applicable

Conditions studied: Tooth Demineralization, White Spot Lesion, Demineralization, Orthodontic Appliance Complication, Dental Braces Complication

In brief

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.

Key facts

Study ID: NCT07355322
Run by: University Hospital, Montpellier
People needed: 34
Starts: 2026-01-01
Expected to finish: 2028-04-01
Last updated by the study team: 2026-01-21

Who can join

Age: 10 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University Hospital Montpellier — Montpellier, France

Full record on ClinicalTrials.gov

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