Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT02359318
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2015-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enamel Damages Following De-bracketing From Infiltrated Surfaces
Sponsor:
DMG Dental Material Gesellschaft mbH
Organization:
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:
False
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?: