Clinical Trials Register

Summary
EudraCT Number:	2010-020538-24
Sponsor's Protocol Code Number:	GASAS-1002X
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-11-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2010-020538-24

A.3

Full title of the trial

White spot lesion development in post-orthodontic patients following weekly application of a 1.25% fluoride gel compared to placebo over 6 months

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

White spot lesion development in post-orthodontic patients following weekly application of a 1.25% fluoride gel compared to placebo over 6 months

A.4.1

Sponsor's protocol code number

GASAS-1002X

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GABA International AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GABA International AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GABA International AG
B.5.2	Functional name of contact point	Scientific Affairs - GASAS-1002X
B.5.3	Address:
B.5.3.1	Street Address	Grabetsmattweg
B.5.3.2	Town/ city	Therwil
B.5.3.3	Post code	4106
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0041614156013
B.5.5	Fax number	0041614156673
B.5.6	E-mail	stephan_glur@gaba.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	elmex gel (25g) 1.25% dental gel
D.2.1.1.2	Name of the Marketing Authorisation holder	GABA GmbH, Berner Weg 7, 79539 Lörrach (Germany)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Dental gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Dental use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Olaflur
D.3.9.1	CAS number	6818-37-7
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30.32
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dectaflur
D.3.9.1	CAS number	36505-83-6
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.87
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium Fluoride
D.3.9.1	CAS number	7681-49-4
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	22.1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Dental gel
D.8.4	Route of administration of the placebo	Dental use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

To monitor the white spot lesion development and dental status under weekly applied 1.25% fluoride gel compared to placebo in patients after orthodontic treatment with multibracket appliances

E.1.1.1

Medical condition in easily understood language

To monitor the white spot lesion development and dental status under weekly applied 1.25% fluoride gel compared to placebo in patients after orthodontic treatment with multibracket appliances

E.1.1.2

Therapeutic area

Diseases [C] - Mouth and tooth diseases [C07]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To monitor the effect of intraoral topical high fluoride application on the development of
white spot lesions (WSL) after orthodontic treatment with multibracket appliances.
Null hypothesis (H0): no difference between verum and placebo group
Alternative hypothesis (H1): verum significantly different from placebo group

Primary Study Parameter:
Changes in size of white spot lesions (WSL) at 12 weeks (lesion size to total labial tooth area, %)

E.2.2

Secondary objectives of the trial

- Changes in size of WSL over study time
- Changes in the mean pixel brightness value of WSL (%)
- Modified white spot lesion index (Gorelick et al. 1982)
- Caries activity index (LAA) according to the ICDAS II (Ekstrand et al.
2007)
- Plaque index (Silness and Löe 1964)
- Gingival bleeding index (Ainamo & Bay 1975)
- DMFT (Klein et al. 1938)

Others:
- Stimulated salivary flow rate
- Saliva buffer capacity
- Questionnaire
- Safety

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Written informed consent
• Healthy volunteers (≥ 11 years) scheduled for bracket removal
• Multibracket appliance therapy in the upper jaw for at least one year
• ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding
• WSL not present at start of orthodontic treatment (comparison with pre-treatment intraoral photographs).
• No restorative or prosthetic therapy planned on UFT
• Agreement of patient (for the whole study duration) not to use any oral hygiene products other than the ones received in this study (allowed in addition: oral irrigator, dental floss and interdental brushes)

E.4

Principal exclusion criteria

• WSL with a modified score 3 (Gorelick et al. 1982) on UFT at debonding
• Ongoing oral or dental treatment except emergency treatment
• 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: Acid Yellow (E 104), Sunset Yellow (E 110), PEG-40 Hydrogenated Castor Oil, Methyl p-Hydroxybenzoate (Parabene E 218), Propyl p-Hydroxybenzoate (Parabene E 216)
• Professional administration of highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. within 30 days prior to enrolment
• Professional administration or home-use of non-study related highly concentrated fluoride products like gels, tablets, varnishes, fillings etc. during the whole study
• Alterations in the teeth’s enamel, e.g. hypoplasia, fluorosis
• Chronic use of medication causing dry mouth
• Known xerostomia
• Medication for central nervous system conditions
• Any illness/condition potentially affecting the study outcome at investigator’s discretion
• Known pregnancy or breast feeding during the course of the study
• Participation in a clinical trial or receipt of an investigational compound/treatment within the last 30 days

E.5 End points

E.5.1

Primary end point(s)

The primary parameter is the difference in DWL%t from T0 to T4 (baseline to 12 weeks):
ΔDWL%t = DWL%t (12 weeks) – DWL%t (baseline)
The white spot lesion area of the test group (elmex® gel) will be compared to the control group (placebo gel).

E.5.1.1

Timepoint(s) of evaluation of this end point

Jun. 2012

E.5.2

Secondary end point(s)

The secondary parameters are as follows:
- SL size at T0, T1, T2, T3, T4, T5
- percentage of lesion size to total labial tooth (DWL%) at T0
- changes of WSL size (absolute) and change in percentage of lesion size to labial tooth (DWL%) from T0 to T1, T2, T3, T5
- mean pixel brightness value of WSL at T0, T1, T2, T3, T4, T5
- changes in the mean pixel brightness value of WSL(%) from T0 to T1, T2, T3, T4, T5 (relating always to the actual WSL-area)
- changes in the mean pixel brightness value of WSL(%) from T0 to T1, T2, T3, T4, T5 (always relating to the baseline WSL-area)
- modified white spot lesion index at all six appointments
- changes of white spot lesion index from T0 to T1, T2, T3, T4, T5
- caries activity index (LAA) at all six appointments
- changes of caries activity index from T0 to T1, T2, T3, T4, T5
- plaque index at all six appointments
- changes of plaque index from T0 to T1, T2, T3, T4, T5
- gingival bleeding index at all six appointments
- changes of gingival bleeding index from T0 to T1, T2, T3, T4, T5
- DMFT index at T0 and T5
- changes of DMFT index from T0 to T5
- stimulated salivary flow rate at T0, T4 and T5
- changes of stimulated salivary flow rate from T0 to T4, T5
- saliva buffer capacity at T0, T1, T4, T5
- changes of saliva buffer capacity from T0 to T1, T4, T5

E.5.2.1

Timepoint(s) of evaluation of this end point

Jun. 2012

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the trial occurs with the final visit of the last randomized subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-10.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Participants, who terminate the study prematurely will obtain a close dental examination. The physician in charge will decide on any necessary further treatment of the WSL.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-01-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-30

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