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Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients

Primary Purpose

Tooth; Lesion, White Spot Lesions

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
elmex® gelée
negative control (placebo)
Sponsored by
Gaba International AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth; Lesion, White Spot Lesions focused on measuring white spot lesion, initial caries, fluoride, amine fluoride, orthodontics, remineralization, brackets

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • Healthy volunteers (≥11 years) scheduled for bracket removal
  • ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding

Exclusion Criteria:

  • Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study
  • Known hypersensitivity or allergy to placebo gel ingredients
  • Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis
  • Any illness/condition potentially affecting the study outcome at investigator's discretion
  • Known pregnancy or breast feeding during the course of the study

Sites / Locations

  • Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test

Control

Arm Description

1.25% fluoride (elmex® gelée)

0% fluoride (negative control)

Outcomes

Primary Outcome Measures

WSL-size change
Changes in size of white spot lesions (WSL) at 12 weeks

Secondary Outcome Measures

WSL-size change
Changes in size of WSL over study time
WSL-brightness change
Changes in WSL brightness value (%)
WSL index on all upper front teeth
Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation slight white spot formation, thin rim excessive white spot formation, thicker bands white spot formation with cavitation
Caries activity
Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
Plaque index (Silness and Löe 1964)on all upper front teeth
The grades will be assessed visually on all upper front teeth using a standard dental probe. (0) no plaque on inspection and probing thin plaque film on gingival margin, detectable only on probing moderate plaque film along the gingival margin, visually detectable even without probing a lot of plaque along the gingival margin, filling the interdental spaces
Gingival bleeding index on all upper front teeth
Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding (1) bleeding occurs
DMFT index: Dental health of all teeth
DMFT index according to Klein et al. (1938): Dental health of all teeth will be assessed with respect to decay (D), missing (M) or filling (F). The DMFT-Index will be calculated.

Full Information

First Posted
April 1, 2011
Last Updated
December 10, 2013
Sponsor
Gaba International AG
Collaborators
PD Dr. Christian Heumann
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1. Study Identification

Unique Protocol Identification Number
NCT01329731
Brief Title
Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients
Official Title
White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaba International AG
Collaborators
PD Dr. Christian Heumann

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth; Lesion, White Spot Lesions
Keywords
white spot lesion, initial caries, fluoride, amine fluoride, orthodontics, remineralization, brackets

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Active Comparator
Arm Description
1.25% fluoride (elmex® gelée)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
0% fluoride (negative control)
Intervention Type
Drug
Intervention Name(s)
elmex® gelée
Other Intervention Name(s)
elmex® gel
Intervention Description
1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical
Intervention Type
Drug
Intervention Name(s)
negative control (placebo)
Intervention Description
0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical
Primary Outcome Measure Information:
Title
WSL-size change
Description
Changes in size of white spot lesions (WSL) at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
WSL-size change
Description
Changes in size of WSL over study time
Time Frame
Baseline up to 24 weeks
Title
WSL-brightness change
Description
Changes in WSL brightness value (%)
Time Frame
Baseline up to 24 weeks
Title
WSL index on all upper front teeth
Description
Modified white spot lesion index (Gorelick et al. 1982): 0: no white spot formation slight white spot formation, thin rim excessive white spot formation, thicker bands white spot formation with cavitation
Time Frame
Baseline up to 24 weeks
Title
Caries activity
Description
Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
Time Frame
Baseline up to 24 weeks
Title
Plaque index (Silness and Löe 1964)on all upper front teeth
Description
The grades will be assessed visually on all upper front teeth using a standard dental probe. (0) no plaque on inspection and probing thin plaque film on gingival margin, detectable only on probing moderate plaque film along the gingival margin, visually detectable even without probing a lot of plaque along the gingival margin, filling the interdental spaces
Time Frame
Baseline up to 24 weeks
Title
Gingival bleeding index on all upper front teeth
Description
Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used: (0) no bleeding (1) bleeding occurs
Time Frame
Baseline up to 24 weeks
Title
DMFT index: Dental health of all teeth
Description
DMFT index according to Klein et al. (1938): Dental health of all teeth will be assessed with respect to decay (D), missing (M) or filling (F). The DMFT-Index will be calculated.
Time Frame
Baseline, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Healthy volunteers (≥11 years) scheduled for bracket removal ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding Exclusion Criteria: Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study Known hypersensitivity or allergy to placebo gel ingredients Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis Any illness/condition potentially affecting the study outcome at investigator's discretion Known pregnancy or breast feeding during the course of the study
Facility Information:
Facility Name
Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen
City
Giessen
ZIP/Postal Code
D-35392
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27702807
Citation
Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part II: clinical data evaluation. Eur J Orthod. 2017 Apr 1;39(2):144-152. doi: 10.1093/ejo/cjw061.
Results Reference
derived
PubMed Identifier
27702806
Citation
Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation. Eur J Orthod. 2017 Apr 1;39(2):134-143. doi: 10.1093/ejo/cjw060.
Results Reference
derived

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Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients

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