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

NCT01329731 | Completed Phase 4 DMC

• 2 other identifiers: GASAS-1002X2010-020538-24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth; Lesion, White Spot Lesions

Keywords

white spot lesion; initial caries; fluoride; amine fluoride; orthodontics; remineralization; brackets

Outcome Measures

Primary Outcomes (1)

• WSL-size change

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

  12 weeks

Secondary Outcomes (7)

• WSL-size change

  Baseline up to 24 weeks

• WSL-brightness change

  Baseline up to 24 weeks

• WSL index on all upper front teeth

  Baseline up to 24 weeks

• Caries activity

  Baseline up to 24 weeks

• Plaque index (Silness and Löe 1964)on all upper front teeth

  Baseline up to 24 weeks

Study Arms (2)

Test

ACTIVE COMPARATOR

1.25% fluoride (elmex® gelée)

Drug: elmex® gelée

Control

PLACEBO COMPARATOR

0% fluoride (negative control)

Drug: negative control (placebo)

Interventions

elmex® gelée DRUG

1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical

Also known as: elmex® gel

Test

negative control (placebo) DRUG

0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical

Control

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaba International AG: lead
• PD Dr. Christian Heumann: collaborator

Study Sites (1)

Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen

Giessen, D-35392, Germany

Location

Related Publications (2)

• 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.

  PMID: 27702807 DERIVED

• 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.

  PMID: 27702806 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 6, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2011-05

Locations

DE (1)