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

Purpose

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.

Condition	Intervention	Phase
Tooth; Lesion, White Spot Lesions	Drug: elmex® gelée Drug: negative control (placebo)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Rashes

Drug Information available for: Fluorine Fluoride

U.S. FDA Resources

Further study details as provided by Gaba International AG:

Primary Outcome Measures:

WSL-size change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in size of white spot lesions (WSL) at 12 weeks

Secondary Outcome Measures:

WSL-size change [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
Changes in size of WSL over study time
WSL-brightness change [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
Changes in WSL brightness value (%)
WSL index on all upper front teeth [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
Modified white spot lesion index (Gorelick et al. 1982):

0: no white spot formation
1. slight white spot formation, thin rim
2. excessive white spot formation, thicker bands
3. white spot formation with cavitation
Caries activity [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
Plaque index (Silness and Löe 1964)on all upper front teeth [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
The grades will be assessed visually on all upper front teeth using a standard dental probe.

(0) no plaque on inspection and probing
1. thin plaque film on gingival margin, detectable only on probing
2. moderate plaque film along the gingival margin, visually detectable even without probing
3. a lot of plaque along the gingival margin, filling the interdental spaces
Gingival bleeding index on all upper front teeth [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
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.


Enrollment:	48
Study Start Date:	March 2011
Study Completion Date:	October 2013
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Test 1.25% fluoride (elmex® gelée)	Drug: elmex® gelée 1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical Other Name: elmex® gel
Placebo Comparator: Control 0% fluoride (negative control)	Drug: negative control (placebo) 0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical

Eligibility


Ages Eligible for Study:	11 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329731

Locations


Germany
Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen
Giessen, Germany, D-35392

Sponsors and Collaborators

Gaba International AG

PD Dr. Christian Heumann

More Information


Responsible Party:	Gaba International AG
ClinicalTrials.gov Identifier:	NCT01329731 History of Changes
Other Study ID Numbers:	GASAS-1002X 2010-020538-24
Study First Received:	April 1, 2011
Last Updated:	December 10, 2013
Health Authority:	Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gaba International AG:


white spot lesion initial caries fluoride amine fluoride	orthodontics remineralization brackets

Additional relevant MeSH terms:


Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Fluorides	Olaflur Cariostatic Agents Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016