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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transbond™ XT bonding procedure

    Device

    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

    Device

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Transbond™ XT (3-step system)Active comparator 1 intervention
Group B: GC Ortho Connect™ (2-step system)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Enamel Decalcification Index (EDI) after Debonding

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.

Time frame
Up to 24 months

Secondary outcomes

1

Mean EDI per Hemi-Arch

Mean Enamel Decalcification Index (EDI) per maxillary hemi-arch, using intraoral photographs and fluorescence intraoral camera, to the 0-3 scoring system of the Enamel Decalcification Index (EDI) by Banks \& Richmond, 1994.

Time frame
Preprocedural
2

Mean EDI per Hemi-Arch

Mean Enamel Decalcification Index (EDI) per maxillary hemi-arch, using intraoral photographs and fluorescence intraoral camera, to the 0-3 scoring system of the Enamel Decalcification Index (EDI) by Banks \& Richmond, 1994.

Time frame
6 months
3

Mean EDI per Hemi-Arch

Mean Enamel Decalcification Index (EDI) per maxillary hemi-arch, using intraoral photographs and fluorescence intraoral camera, to the 0-3 scoring system of the Enamel Decalcification Index (EDI) by Banks \& Richmond, 1994.

Time frame
12 months
4

EDI per Tooth

Enamel Decalcification Index (EDI) measured per tooth, according to the 0-3 EDI scoring system.

Time frame
Preprocedural

Other outcomes

Sponsors and contacts

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