Dental White SpotsNCT02359318
Enamel Damages Following De-bracketing From Infiltrated Surfaces
A study testing Resin infiltration and Bonding and debonding of brackets. in people with Dental White Spots, run by DMG Dental Material Gesellschaft mbH at 1 site in Chile.
Trial summary
Demineralisation and white-spot caries often occures during MB treatment. While resin infiltration has been proved to stop progression of enamel demineralisation, there is still a paucity of information in the literature concerning the best time point of infiltration: During or following MB treatment. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental White Spots
- What is being tested?
- Resin infiltration and Bonding and debonding of brackets.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- May 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Multibracket apparature with: At least 4 post-orthodontic white spots on front teeth (canines and / or incisors) in upper and lower jaw (study group) OR
- No post-orthodontic white spot or any other enamel damage - on front teeth (canines and / or incisors) in upper and lower jaw (control group) AND
- No cavitation of vestibular tooth surface(s) AND
- Patients willing to participate in the study and accepting to attend recall visits
Who cannot join
- Cavitation of vestibular tooth surface(s)
- Participation in other study
- History of allergy towards any dental material.
- Subjects with any systemic and local conditions not permitting the treatment
- Subjects with direct or indirect restorations in maxillary central or lateral incisors.
- Subjects not willing to participate in the study
Show all 9Show fewer
- Subjects with fractured teeth maxillary central or lateral incisors
- No or less than 4 post-orthodontic white spots on front teeth (canines or incisors) in upper or lower jaw (study group)
- Post-orthodontic white spots or any other enamel damage on front teeth or incisors (control group)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enamel Damages Following De-bracketing of Demineralised Teeth With or Without Prior Infiltration Compared to Sound Enamel: A Single-center, Randomized, Single Blinded, Split-mouth Controlled Clinical Trial
Demineralisation and white-spot caries often occures during MB treatment. While resin infiltration has been proved to stop progression of enamel demineralisation, there is still a paucity of information in the literature concerning the best time point of infiltration: During or following MB treatment. Infiltration during treatment requires debonding respective brackets prior to infiltration, with subsequent re-bonding. In terms of preventing enamel damages by progression of demineralisation and enamel damages by de-bonding, it is unclear whether it was better to infiltrate enamel immediately, or to better postpone until completion of MB treatment.
This study thus aimes to evaluate if resin infiltration can prevent enamel damage due to bracket de-bonding.
Read the detailed description
Background: Orthodontic bracket debonding is known to cause side-effects such as enamel cracks or fractures. There is a lack of information on potential benefits or side-effects of removing brackets from infiltrated enamel, in terms of enamel damages, in vivo.
Purpose: To assess enamel damages following debonding in demineralised teeth with or without prior infiltration (Icon, DMG, Hamburg, Germany), compared to those following bracket removal from sound enamel, in order to provide guidelines for the right time point of infiltration of post-orthodontic lesions (during or following orthodontic treatment).
Design: Single-center, randomized, single blinded, split-mouth controlled clinical trial Subjects: 30 subjects with fixed multi-bracket (MB) appliances treated at the orthodontic clinic of Dr. Roberto Vogel, Temuco, Chile: It is planned to include 20 consecutive patients with extensive decalcifications, and 10 patients without decalcifications. Random allocation of demineralized dental arch quadrants to the different treatment groups (debond with or without prior infiltration, and sound teeth).
Investigated tooth groups: Upper and lower canines, and upper and lower incisors.
Methods: Bracket bonding procedure (Transbond XT 3M, Unitek) is identical for all patients and also for the re-attachement of brackets. Teeth allocated to the infiltration group will receive bracket removal, infiltration and rebonding of new brackets 4 weeks prior to final debonding. De-bonding procedures are identical for all patients.
Silicone replicas are made directly following bracket removal (prior to adhesive removal). Replica analysis is performed using a confocal microscope (Zeiss LSM780) at the Department of Cell Biology, University of Concepción, Chile.
- Conditions
- Dental White Spots
- Being tested
- Resin infiltration, Bonding and debonding of brackets.
- Keywords
- White spot lesion, Resin Infiltration, Icon, Debonding, Enamel damages, Orthodontic white spots, Orthodontics
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationProcedure or surgery
Also called Icon (DMG, Germany), Approximal resin infiltration kit
Resin infiltration is done according to manufactures´ instructions after de-bonding of old brackets and prior bonding of new brackets.
Bonding and debonding of brackets.Procedure or surgery
Also called Gemini metal brackets (3M Unitek)
Brackets (Gemini metal brackets (3M Unitek) are bonded and de-bonded by one clinician (Roberto Vogel) and using the same bonding and de-bonding techniques and materials for all patients. All brackets were finally de-bonded at the end of the treatment, with silicon impressions taken before adhesive removal.
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration and de-bonding | Experimental | Patients with brackets and white spots are included in this group. After removal of the old brackets the quadrants are randomized to this intervention arm and the "no infiltration and de-bonding" arm. The teeth that are included in this intervention arm are treated by resin infiltration using Icon (DMG, Germany) according to the manufacturers´ instruction. This is followed by bonding of new brackets (Gemini metal brackets, 3M Unitek). These new brackets are finally de-bonded 4 weeks after the treatment, with silicon impressions taken before adhesive removal.
Bonding and debonding of brackets is performed by one clinician (Roberto Vogel) using the same bonding and de-bonding techniques and materials for all patients. Receives: Procedure: Resin infiltration; Procedure: Bonding and debonding of brackets. |
| No infiltration and de-bonding | Placebo comparator | Patients with brackets and white spots are included in this group. After removal of the old brackets the quadrants are randomized to this intervention arm and the "resin infiltration and de-bonding" arm. The teeth that are included in this intervention arm are left untreated new brackets (Gemini metal brackets, 3M Unitek) are bonded. These new brackets are finally de-bonded 4 weeks after the treatment, with silicon impressions taken before adhesive removal.
Bonding and debonding of brackets is performed by one clinician (Roberto Vogel) using the same bonding and de-bonding techniques and materials for all patients. Receives: Procedure: Bonding and debonding of brackets. |
| Control and de-bonding | Other | Patients with brackets and without white spots are included in this group. After removal of the old brackets, new brackets (Gemini metal brackets, 3M Unitek) are bonded again. These new brackets are finally de-bonded 4 weeks after the treatment, with silicon impressions taken before adhesive removal.
Bonding and debonding of brackets is performed by one clinician (Roberto Vogel) using the same bonding and de-bonding techniques and materials for all patients. Receives: Procedure: Bonding and debonding of brackets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface damages
Number of cracks and fractures as assessed by enamel surface analysis via silicone replicas using CLSM
Measured: 4 weeks after deboning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental White SpotsStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de La Frontera, Universidad de Concepcion
- Responsible party
- Sponsor
- Investigators
- Michael Knösel, Principal investigator, University Medical Center (UMG) Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359318
- Sponsor's protocol ID
- RIDeBond
- Status last verified
- Apr 2022
- First submitted
- 22 Jan 2015
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Damages Following De-bracketing of Demineralised Teeth With or Without Prior Infiltration Compared to Sound Enamel: A Single-center, Randomized, Single Blinded, Split-mouth Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02359318
- Acronym / sponsor ID
- RIDeBond
- Conditions
- Dental White Spots
- Keywords
- White spot lesion, Resin Infiltration, Icon, Debonding, Enamel damages, Orthodontic white spots, Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Collaborators
- Universidad de La Frontera, Universidad de Concepcion
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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.
Demineralisation and white-spot caries often occures during MB treatment. While resin infiltration has been proved to stop progression of enamel demineralisation, there is still a paucity of information in the literature concerning the best time point of infiltration: During or following MB treatment. Infiltration during treatment requires debonding respective brackets prior to infiltration, with subsequent re-bonding. In terms of preventing enamel damages by progression of demineralisation and enamel damages by de-bonding, it is unclear whether it was better to infiltrate enamel immediately, or to better postpone until completion of MB treatment.
This study thus aimes to evaluate if resin infiltration can prevent enamel damage due to bracket de-bonding.
Detailed description
Background: Orthodontic bracket debonding is known to cause side-effects such as enamel cracks or fractures. There is a lack of information on potential benefits or side-effects of removing brackets from infiltrated enamel, in terms of enamel damages, in vivo.
Purpose: To assess enamel damages following debonding in demineralised teeth with or without prior infiltration (Icon, DMG, Hamburg, Germany), compared to those following bracket removal from sound enamel, in order to provide guidelines for the right time point of infiltration of post-orthodontic lesions (during or following orthodontic treatment).
Design: Single-center, randomized, single blinded, split-mouth controlled clinical trial Subjects: 30 subjects with fixed multi-bracket (MB) appliances treated at the orthodontic clinic of Dr. Roberto Vogel, Temuco, Chile: It is planned to include 20 consecutive patients with extensive decalcifications, and 10 patients without decalcifications. Random allocation of demineralized dental arch quadrants to the different treatment groups (debond with or without prior infiltration, and sound teeth).
Investigated tooth groups: Upper and lower canines, and upper and lower incisors.
Methods: Bracket bonding procedure (Transbond XT 3M, Unitek) is identical for all patients and also for the re-attachement of brackets. Teeth allocated to the infiltration group will receive bracket removal, infiltration and rebonding of new brackets 4 weeks prior to final debonding. De-bonding procedures are identical for all patients.
Silicone replicas are made directly following bracket removal (prior to adhesive removal). Replica analysis is performed using a confocal microscope (Zeiss LSM780) at the Department of Cell Biology, University of Concepción, Chile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration and de-bonding | Experimental | Procedure: Resin infiltration, Procedure: Bonding and debonding of brackets.Patients with brackets and white spots are included in this group. After removal of the old brackets the quadrants are randomized to this intervention arm and the "no infiltration and de-bonding" arm. The teeth that are included in this intervention arm are treated by resin infiltration using Icon (DMG, Germany) according to the manufacturers´ instruction. This is followed by bonding of new brackets (Gemini metal brackets, 3M Unitek). These new brackets are finally de-bonded 4 weeks after the treatment, with silicon impressions taken before adhesive removal. Bonding and debonding of brackets is performed by one clinician (Roberto Vogel) using the same bonding and de-bonding techniques and materials for all patients. |
| No infiltration and de-bonding | Placebo comparator | Procedure: Bonding and debonding of brackets.Patients with brackets and white spots are included in this group. After removal of the old brackets the quadrants are randomized to this intervention arm and the "resin infiltration and de-bonding" arm. The teeth that are included in this intervention arm are left untreated new brackets (Gemini metal brackets, 3M Unitek) are bonded. These new brackets are finally de-bonded 4 weeks after the treatment, with silicon impressions taken before adhesive removal. Bonding and debonding of brackets is performed by one clinician (Roberto Vogel) using the same bonding and de-bonding techniques and materials for all patients. |
| Control and de-bonding | Other | Procedure: Bonding and debonding of brackets.Patients with brackets and without white spots are included in this group. After removal of the old brackets, new brackets (Gemini metal brackets, 3M Unitek) are bonded again. These new brackets are finally de-bonded 4 weeks after the treatment, with silicon impressions taken before adhesive removal. Bonding and debonding of brackets is performed by one clinician (Roberto Vogel) using the same bonding and de-bonding techniques and materials for all patients. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Multibracket apparature with: At least 4 post-orthodontic white spots on front teeth (canines and / or incisors) in upper and lower jaw (study group) OR
- No post-orthodontic white spot or any other enamel damage - on front teeth (canines and / or incisors) in upper and lower jaw (control group) AND
- No cavitation of vestibular tooth surface(s) AND
- Patients willing to participate in the study and accepting to attend recall visits
Key exclusion criteria (9 listed)
- Cavitation of vestibular tooth surface(s)
- Participation in other study
- History of allergy towards any dental material.
- Subjects with any systemic and local conditions not permitting the treatment
- Subjects with direct or indirect restorations in maxillary central or lateral incisors.
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 |
|---|---|---|
| Resin infiltrationAlso: Icon (DMG, Germany), Approximal resin infiltration kitResin infiltration is done according to manufactures´ instructions after de-bonding of old brackets and prior bonding of new brackets. | Procedure or surgery | Resin infiltration and de-bonding |
| Bonding and debonding of brackets.Also: Gemini metal brackets (3M Unitek)Brackets (Gemini metal brackets (3M Unitek) are bonded and de-bonded by one clinician (Roberto Vogel) and using the same bonding and de-bonding techniques and materials for all patients. All brackets were finally de-bonded at the end of the treatment, with silicon impressions taken before adhesive removal. | Procedure or surgery | Control and de-bonding, No infiltration and de-bonding, Resin infiltration and de-bonding |
Primary outcome
Surface damages
Time frame: 4 weeks after deboning
Number of cracks and fractures as assessed by enamel surface analysis via silicone replicas using CLSM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Related trials for Dental White Spots
Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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. This study is not recruiting at the moment.
Michael Knösel principal investigator
University Medical Center (UMG) Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration and Bonding and debonding of brackets. in people with Dental White Spots, run by DMG Dental Material Gesellschaft mbH at 1 site in Chile.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 21 Apr 2022. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface damages (time frame: 4 weeks after deboning). 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 Apr 2022.