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

NCT07355322 | Not Yet Recruiting

• 2 other identifiers: RECHMPL24_02712025-A01740-49
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Demineralization; White Spot Lesion; Demineralization; Orthodontic Appliance Complication; Dental Braces Complication

Keywords

White spot lesions; Orthodontic bonding; Enamel demineralization; Transbond XT; GC Ortho Connect; Split-mouth trial; Orthodontic Brackets; Fixed Orthodontic Appliances; Adolescents; Oral Hygiene; Dental Plaque; Orthodontic Adhesives; Bracket detachment; Bracket debonding

Outcome Measures

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.

  Up to 24 months

Secondary Outcomes (20)

• Mean EDI per Hemi-Arch

  Preprocedural

• Mean EDI per Hemi-Arch

  6 months

• Mean EDI per Hemi-Arch

  12 months

• EDI per Tooth

  Preprocedural

• EDI per Tooth

  6 months

Study Arms (2)

Transbond™ XT (3-step system)

ACTIVE COMPARATOR

Conventional 3-step bonding system applied on one hemi-arch: acid etching, primer application, adhesive placement, and light curing. Serves as control.

Device: Transbond™ XT bonding procedure

GC Ortho Connect™ (2-step system)

EXPERIMENTAL

Simplified 2-step bonding system applied on contralateral hemi-arch: acid etching followed by adhesive with integrated primer and light curing. Evaluates potential reduction in enamel demineralization.

Device: GC Ortho Connect™ bonding procedure

Interventions

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.

Transbond™ XT (3-step system)

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.

GC Ortho Connect™ (2-step system)

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Tooth Demineralization; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Study Officials

• Stéphane BARTHELEMI, PU-PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane BARTHELEMI, PU-PH

CONTACT

+33 6 47 75 55 33; s-barthelemi@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (1)