Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02359318
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2015-01-22
Brief Title:
Enamel Damages Following De-bracketing From Infiltrated Surfaces
Sponsor:
DMG Dental Material Gesellschaft mbH
Organization:
DMG Dental Material Gesellschaft mbH
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None