NCT02359318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

January 22, 2015

Last Update Submit

April 20, 2022

Conditions

Dental White Spots

Keywords

White spot lesionResin InfiltrationIconDebondingEnamel damagesOrthodontic white spotsOrthodontics

Outcome Measures

Primary Outcomes (1)

  • Surface damages

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

    4 weeks after deboning

Study Arms (3)

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.

Procedure: Resin infiltrationProcedure: 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.

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.

Procedure: Bonding and debonding of brackets.

Interventions

Resin infiltrationPROCEDURE

Resin infiltration is done according to manufactures´ instructions after de-bonding of old brackets and prior bonding of new brackets.

Also known as: Icon (DMG, Germany), Approximal resin infiltration kit
Resin infiltration and de-bonding
Bonding and debonding of brackets.PROCEDURE

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.

Also known as: Gemini metal brackets (3M Unitek)
Control and de-bondingNo infiltration and de-bondingResin infiltration and de-bonding

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic

Temuco, Región de la Araucanía, 4800949, Chile

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Michael Knösel

    University Medical Center (UMG) Göttingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 10, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

CL(1)