Tooth DemineralizationORTHOCOLLAGENCT07355322
Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
A study testing Transbond™ XT bonding procedure and GC Ortho Connect™ bonding procedure in people with Tooth Demineralization and White Spot Lesion, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Tooth Demineralization, White Spot Lesion, Demineralization
- What is being tested?
- Transbond™ XT bonding procedure and GC Ortho Connect™ bonding procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Montpellier
Montpellier
Stéphane BARTHELEMI, +33 6 47 75 55 33, s-barthelemi@chu-montpellier.fr
About this study
Official title: Comparison of a 3-step Bonding System (TRANSBOND™ XT) Versus a 2-step System (GC ORTHO CONNECT™) on Demineralization Around Maxillary Orthodontic Brackets: a Randomized Split-mouth Clinical 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.
Read the detailed description
Introduction:
White spot lesions (WSLs) (localized, non-cavitated enamel demineralizations) represent one of the most frequent side effects of fixed orthodontic treatments. Clinically visible in up to 97% of patients undergoing labial orthodontic therapy, these lesions can emerge as early as the fourth week of treatment. They result from microleakage at the adhesive enamel interface, which facilitates bacterial colonization and acid production. Beyond their aesthetic impact, WSLs can compromise bracket adhesion and increase the risk of failure
Fixed orthodontic appliances modify the oral ecosystem, favoring plaque accumulation and hindering efficient brushing, particularly around complex elements such as ligatures, brackets, and springs. Consequently, WSLs constitute a significant clinical concern for both orthodontists and dental surgeons, as these lesions can persist five years after treatment completion.
Bonding Systems Under Investigation :
The conventional bonding protocol, Transbond™ XT, involves three steps: etching, primer application, and adhesive placement. Conversely, the GC Ortho Connect™ system integrates the primer directly into the adhesive, simplifying the bonding procedure to a single step following orthophosphoric acid etching. This reduced protocol minimizes saliva exposure time and enhances bonding strength.
Furthermore, GC Ortho Connect™ contains functional monomers such as 10-MDP (10-methacryloyloxydecyl dihydrogen phosphate), which chemically interacts with hydroxyapatite, forming a stable bond resistant to moisture. While some studies suggest this system reduces the risk of contamination and shortens chairside time, others report slightly deeper and larger lesions compared to the conventional three-step approach. Evidence remains contradictory, with several in vitro studies showing no significant difference in enamel quality between the two bonding systems.
Research Hypothesis and Objectives :
This clinical trial aims to determine whether a significant difference exists in enamel demineralization between a three-step (Transbond™ XT) and a two-step (GC Ortho Connect™) bonding system.
- Primary Objective: Compare the degree of enamel demineralization around orthodontic brackets at debonding between the two systems using intraoral photographs (Enamel Decalcification Index, EDI) and fluorescence imaging (C50 Acteon camera).
- Secondary Objectives:
- Assess enamel demineralization before bonding, at 6 months, and at 12 months.
- Compare bracket failure rates throughout treatment.
- Evaluate plaque accumulation using the Silness and Löe plaque index.
Methodology :
A monocentric randomized split-mouth trial will be conducted at the Montpellier Dental Care Center. Each patient will serve as their own control:
One hemi-arch (control) bonded with Transbond™ XT (3-step system).
The opposite hemi-arch (experimental) bonded with GC Ortho Connect™ (2-step system).
Randomization will be stratified by gender and brushing hand dominance to reduce confounding factors. Inclusion criteria target minors aged 10-16 years requiring fixed labial metallic appliances.
The split-mouth design minimizes interindividual variability (e.g., enamel quality, saliva composition, hygiene habits) and increases statistical power. Additionally, enamel demineralization assessment will be conducted by a blinded examiner to ensure unbiased evaluation.
Conclusion :
This study proposes an innovative clinical comparison between two orthodontic bonding systems to assess their effects on enamel demineralization. If the simplified GC Ortho Connect™ system demonstrates similar or superior outcomes to the conventional Transbond™ XT, it could represent a time-saving, contamination-resistant, and more conservative alternative for orthodontic bonding procedures ultimately improving patient safety and clinical efficiency.
- Conditions
- Tooth Demineralization, White Spot Lesion, Demineralization, Orthodontic Appliance Complication, Dental Braces Complication
- Being tested
- Transbond™ XT bonding procedure, GC Ortho Connect™ bonding procedure
- 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
- Medical subject headings
- Tooth Demineralization, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbond™ XT bonding procedureDevice
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 procedureDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: GC Ortho Connect™ bonding procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (20)
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.
Measured: Preprocedural
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.
Measured: 6 months
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.
Measured: 12 months
EDI per Tooth
Enamel Decalcification Index (EDI) measured per tooth, according to the 0-3 EDI scoring system.
Measured: Preprocedural
EDI per Tooth
Enamel Decalcification Index (EDI) measured per tooth, according to the 0-3 EDI scoring system.
Measured: 6 months
EDI per Tooth
Enamel Decalcification Index (EDI) measured per tooth, according to the 0-3 EDI scoring system.
Measured: 12 months
EDI per Tooth
Enamel Decalcification Index (EDI) measured per tooth, according to the 0-3 EDI scoring system.
Measured: Up to 24 months
Occurrence of bracket Detachment per tooth
Measured: 6 months
Occurrence of bracket Detachment per tooth
Measured: 12 months
Occurrence of bracket Detachment per tooth
Measured: Up to 24 months
Total number of detachments per tooth
Measured: 6 months
Total number of detachments per tooth
Measured: 12 months
Total number of detachments per tooth
Measured: Up to 24 months
Total number of detachments per patient
Measured: 6 months
Total number of detachments per patient
Measured: 12 months
Total number of detachments per patient
Measured: Up to 24 months
Plaque Index
Plaque Index scored 0-3 according to Silness \& Loe, measured with a probe N°6
Measured: Preprocedural
Plaque Index
Plaque Index scored 0-3 according to Silness \& Loe, measured with a probe N°6
Measured: 6 months
Plaque Index
Plaque Index scored 0-3 according to Silness \& Loe, measured with a probe N°6
Measured: 12 months
Plaque Index
Plaque Index scored 0-3 according to Silness \& Loe, measured with a probe N°6
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DemineralizationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane BARTHELEMI, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355322
- Sponsor's protocol ID
- RECHMPL24_0271
- Other IDs
- 2025-A01740-49
- Acronym
- ORTHOCOLLAGE
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a 3-step Bonding System (TRANSBOND™ XT) Versus a 2-step System (GC ORTHO CONNECT™) on Demineralization Around Maxillary Orthodontic Brackets: a Randomized Split-mouth Clinical Trial.
- ClinicalTrials.gov ID
- NCT07355322
- Acronym / sponsor ID
- ORTHOCOLLAGE / RECHMPL24_0271
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
White spot lesions (WSLs) (localized, non-cavitated enamel demineralizations) represent one of the most frequent side effects of fixed orthodontic treatments. Clinically visible in up to 97% of patients undergoing labial orthodontic therapy, these lesions can emerge as early as the fourth week of treatment. They result from microleakage at the adhesive enamel interface, which facilitates bacterial colonization and acid production. Beyond their aesthetic impact, WSLs can compromise bracket adhesion and increase the risk of failure
Fixed orthodontic appliances modify the oral ecosystem, favoring plaque accumulation and hindering efficient brushing, particularly around complex elements such as ligatures, brackets, and springs. Consequently, WSLs constitute a significant clinical concern for both orthodontists and dental surgeons, as these lesions can persist five years after treatment completion.
Bonding Systems Under Investigation :
The conventional bonding protocol, Transbond™ XT, involves three steps: etching, primer application, and adhesive placement. Conversely, the GC Ortho Connect™ system integrates the primer directly into the adhesive, simplifying the bonding procedure to a single step following orthophosphoric acid etching. This reduced protocol minimizes saliva exposure time and enhances bonding strength.
Furthermore, GC Ortho Connect™ contains functional monomers such as 10-MDP (10-methacryloyloxydecyl dihydrogen phosphate), which chemically interacts with hydroxyapatite, forming a stable bond resistant to moisture. While some studies suggest this system reduces the risk of contamination and shortens chairside time, others report slightly deeper and larger lesions compared to the conventional three-step approach. Evidence remains contradictory, with several in vitro studies showing no significant difference in enamel quality between the two bonding systems.
Research Hypothesis and Objectives :
This clinical trial aims to determine whether a significant difference exists in enamel demineralization between a three-step (Transbond™ XT) and a two-step (GC Ortho Connect™) bonding system.
- Primary Objective: Compare the degree of enamel demineralization around orthodontic brackets at debonding between the two systems using intraoral photographs (Enamel Decalcification Index, EDI) and fluorescence imaging (C50 Acteon camera).
- Secondary Objectives:
- Assess enamel demineralization before bonding, at 6 months, and at 12 months.
- Compare bracket failure rates throughout treatment.
- Evaluate plaque accumulation using the Silness and Löe plaque index.
Methodology :
A monocentric randomized split-mouth trial will be conducted at the Montpellier Dental Care Center. Each patient will serve as their own control:
One hemi-arch (control) bonded with Transbond™ XT (3-step system).
The opposite hemi-arch (experimental) bonded with GC Ortho Connect™ (2-step system).
Randomization will be stratified by gender and brushing hand dominance to reduce confounding factors. Inclusion criteria target minors aged 10-16 years requiring fixed labial metallic appliances.
The split-mouth design minimizes interindividual variability (e.g., enamel quality, saliva composition, hygiene habits) and increases statistical power. Additionally, enamel demineralization assessment will be conducted by a blinded examiner to ensure unbiased evaluation.
Conclusion :
This study proposes an innovative clinical comparison between two orthodontic bonding systems to assess their effects on enamel demineralization. If the simplified GC Ortho Connect™ system demonstrates similar or superior outcomes to the conventional Transbond™ XT, it could represent a time-saving, contamination-resistant, and more conservative alternative for orthodontic bonding procedures ultimately improving patient safety and clinical efficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transbond™ XT (3-step system) | Active comparator | Device: Transbond™ XT bonding procedureConventional 3-step bonding system applied on one hemi-arch: acid etching, primer application, adhesive placement, and light curing. Serves as control. |
| GC Ortho Connect™ (2-step system) | Experimental | Device: GC Ortho Connect™ bonding procedureSimplified 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbond™ XT bonding procedureBrackets are bonded to one hemi-arch using the 3-step protocol: 1) acid etching, 2) primer application, 3) adhesive placement and light curing. | Device | Transbond™ XT (3-step system) |
| GC Ortho Connect™ bonding procedureBrackets are bonded to the contralateral hemi-arch using the 2-step protocol: 1) acid etching, 2) adhesive with integrated primer, followed by light curing. | Device | GC Ortho Connect™ (2-step system) |
Primary outcome
Mean Enamel Decalcification Index (EDI) after Debonding
Time frame: 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.
20 secondary outcomes
Mean EDI per Hemi-Arch
Time frame: Preprocedural
Mean EDI per Hemi-Arch
Time frame: 6 months
Mean EDI per Hemi-Arch
Time frame: 12 months
EDI per Tooth
Time frame: Preprocedural
EDI per Tooth
Time frame: 6 months
EDI per Tooth
Time frame: 12 months
EDI per Tooth
Time frame: Up to 24 months
Occurrence of bracket Detachment per tooth
Time frame: 6 months
Occurrence of bracket Detachment per tooth
Time frame: 12 months
Occurrence of bracket Detachment per tooth
Time frame: Up to 24 months
Total number of detachments per tooth
Time frame: 6 months
Total number of detachments per tooth
Time frame: 12 months
Total number of detachments per tooth
Time frame: Up to 24 months
Total number of detachments per patient
Time frame: 6 months
Total number of detachments per patient
Time frame: 12 months
Total number of detachments per patient
Time frame: Up to 24 months
Plaque Index
Time frame: Preprocedural
Plaque Index
Time frame: 6 months
Plaque Index
Time frame: 12 months
Plaque Index
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane BARTHELEMI, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbond™ XT bonding procedure and GC Ortho Connect™ bonding procedure in people with Tooth Demineralization and White Spot Lesion, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane BARTHELEMI, PU-PH (+33 6 47 75 55 33, s-barthelemi@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Enamel Decalcification Index (EDI) after Debonding (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.