search
Back to results

Enamel Damages Following De-bracketing From Infiltrated Surfaces

Primary Purpose

Dental White Spots

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Resin infiltration
Bonding and debonding of brackets.
Sponsored by
DMG Dental Material Gesellschaft mbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental White Spots focused on measuring White spot lesion, Resin Infiltration, Icon, Debonding, Enamel damages, Orthodontic white spots, Orthodontics

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Sites / Locations

  • Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Resin infiltration and de-bonding

No infiltration and de-bonding

Control and de-bonding

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Surface damages
Number of cracks and fractures as assessed by enamel surface analysis via silicone replicas using CLSM

Secondary Outcome Measures

Full Information

First Posted
January 22, 2015
Last Updated
April 20, 2022
Sponsor
DMG Dental Material Gesellschaft mbH
Collaborators
Universidad de La Frontera, Universidad de Concepcion
search

1. Study Identification

Unique Protocol Identification Number
NCT02359318
Brief Title
Enamel Damages Following De-bracketing From Infiltrated Surfaces
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DMG Dental Material Gesellschaft mbH
Collaborators
Universidad de La Frontera, Universidad de Concepcion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental White Spots
Keywords
White spot lesion, Resin Infiltration, Icon, Debonding, Enamel damages, Orthodontic white spots, Orthodontics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resin infiltration and de-bonding
Arm Type
Experimental
Arm Description
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.
Arm Title
No infiltration and de-bonding
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control and de-bonding
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Resin infiltration
Other Intervention Name(s)
Icon (DMG, Germany), Approximal resin infiltration kit
Intervention Description
Resin infiltration is done according to manufactures´ instructions after de-bonding of old brackets and prior bonding of new brackets.
Intervention Type
Procedure
Intervention Name(s)
Bonding and debonding of brackets.
Other Intervention Name(s)
Gemini metal brackets (3M Unitek)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surface damages
Description
Number of cracks and fractures as assessed by enamel surface analysis via silicone replicas using CLSM
Time Frame
4 weeks after deboning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Knösel
Organizational Affiliation
University Medical Center (UMG) Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Clinic
City
Temuco
State/Province
Araucanía
ZIP/Postal Code
4800949
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

Enamel Damages Following De-bracketing From Infiltrated Surfaces

We'll reach out to this number within 24 hrs