Download elmex® gel with amine fluoride

elmex® gel with amine fluoride
High-concentrated fluoride pharmaceutical gel for use in intensive
fluoridation of the teeth
Active ingredients:
Amine fluoride (AmF): Olaflur, Dectaflur
Sodium fluoride (NaF)
Fluoride content:
12‘500 ppm Ffrom AmF and NaF
Formulation:
Dental gel with high fluoride concentration
No colorants, no preservatives, no abrasives
pH 4.8
Indication:
For intensive caries prophylaxis, adjunctive treatment of hypersensitive
teeth and initial caries lesions
Therapy:
• For the adjunctive treatment of initial caries lesions
• For the treatment of hypersensitive dental necks
• Remineralisation of initial caries lesions
Individual prophylaxis:
• For intensive caries prophylaxis in children and adults
• For intensive caries prophylaxis in groups with high caries risk, such as
children/adults with orthodontic appliances, bridges or partial prostheses,
and high risk patients with xerostomia
• For intensive dentine caries prophylaxis in case of exposed dental necks
Group prophylaxis:
School prevention programmes as part of health education
For children from the age of 6 on (from 6 to 8 years under parental
supervision only), for adolescents and adults
Product benefits:
Due to its surface activity and the slightly acidic pH, amine fluorides promote the formation of well-adhering calcium fluoride layer on dental
enamel and dentine. These layer acts as a long-lasting fluoride deposit
which protects the tooth against acid attack and stimulates
remineralisation. The amine fluoride layer inhibits bacterial acid production
and reduces the acid solubility of dental enamel. It resists mechanical
abrasion and is imperishable to being rinsed away by saliva.
Amine fluorides are distributed rapidly in the oral cavity, so that areas which
are difficult to reach, such as fissures and the areas between the teeth, are
effectively protected.
Dosage and use
elmex® gel
Domestic dental care
Areas of application:
• Adults: Brush the teeth once a week for 2-3 minutes with
approximately 0.5 g elmex® gel (1-2 cm gel, contains circa
6,25 mg fluoride). Then spit out and rinse.
• Children over the age of 6 years should take care not to
swallow during brushing with elmex® gel and should rinse
the mouth briefly after use. elmex® gel should be used by
children aged 6-8 under parental supervision only.
• Caries-active patients and patients with an increased risk of
caries, e.g. with orthodontic appliances should brush elmex®
gel once a week, higher frequency can be prescribed by
dentist.
• For target use in individuals with exposed dental necks,
apply elmex® gel at least once a week with a soft brush to
the affected areas of the teeth, higher frequency can be
prescribed by dentist.
In schools
Areas of application:
• elmex® gel is suitable as a fluoridation agent for use school
caries prophylaxis programmes. Frequency of use will
depend on organisational factors, but it should be used at
least 6 times a year and in optimum 2–4 times monthly. The
method of application is as described above. The instructor
should control the time of application (2-3 minutes).
In the dental practice
Areas of application:
• Whole dentition: Used for adults and children over the age
of 8 years who are at high risk (e.g. xerostomia patients). A
total of circa 3-8 g gel is applied in the oral cavity with a
tray; this is equivalent to a fluoride dose of 37,5-100 mg.
The gel should not to remain in contact with the teeth for
longer than 5 minutes. The patients should rinse the mouth
after use. The frequency for the home usage should
prescribed by dentist.
• Single tooth: For desensitisation following root planing and
scaling by touch application using a cotton-wool swab or
application by injection.
Advantages:
– Fast and simple use
– In group prophylaxis: motivation of children and promotion o autonomy through proactive behaviour
– Promotion of autonomy also in adults
– Cost-effective
– No preliminary drying of the teeth necessary
Advice:
Do not swallow elmex® gel. Children under the age of 6 should not use
elmex® gel since they are not yet able to control swallowing.
Avoid prolonged contact with oral mucosa! Don’t exceed the brushing time
of 2 to 3 minutes! In case of tray application don’t exceed contact time of 3
to 5 minutes!
Package size:
25 g, 38 g, 215 g
Please note that any statements regarding our medicinal products may vary
slightly from country to country, depending on the requirements of the
respective regulatory authorities.
Clinical study results
Fluoride uptake of incipient carious lesions – an in situ study
In this double-blind, placebo-controlled, 3-way crossover study, subjects
(n=36) applied either placebo gel or 0.5% fluoride gel or 1.25% fluoride
gel. Gels were applied (0.5 g, brushing 3 minutes) once per week topically
on the surface of demineralised bovine enamel specimens worn in intraoral
appliances. 14 days prior to the first application and during the whole study
including washout periods, subjects used a fluoride-free toothpaste. Specimens were analysed for remineralisation by transversal microradiography
and for fluoride uptake using an ion-sensitive fluoride electrode after 10
minutes and 1, 2, 3, and 4 weeks of gel applications (once weekly).
Fluoride uptake after 4 weeks of application of
differently concentrated fluoride gels in situ
Fluoride uptake
3500
3000
2500
Altenburger et al. 2008
**
*
* p<0.001, placebo vs.
fluoride gels 0.5% and 1.25%
** p<0.01, fluoride gel 1.25% vs.
fluoride gel 0.5%
2000
*
1500
1000
500
0
Placebo
Fluoride
gel 0.5%
Fluoride
gel 1.25%
Fig.1: Fluoride uptake of demineralised enamel specimens is significantly higher after weekly
topical applications of a gel containing 0.5% or 1.25% fluoride compared to a fluoride-free gel
over a period of 4 weeks. The difference between the two fluoride gels also reached statistical
significance.
In incipient carious lesions, elmex® gel (1.25% F- ) significantly promotes
fluoride uptake compared to the gel with lower fluoride concentration
(0.5% F - ) or placebo.
Efficient caries prophylaxis with elmex® gel
Aim of this two year clinical trial (placebo-controlled and double-blinded)
was to investigate the efficiency of the combined use of elmex® CARIES
PROTECTION toothpaste (1250 ppmF-) and elmex® gel in the prophylaxis
of caries. Adolescents were devided into two test groups: one group A
using elmex® CARIES PROTECTION tootphaste (twice daily) and elmex®
gel (once weekly), and one group B using elmex® CARIES PROTECTION
toothpaste and a placebo gel in the same frequency. A third group that
continued their usual oral care routine served as control.
The greatest reduction in caries development was seen in test group A:
DMFS scores increased statistically significant less by 38 % (∆-DMFS = 1.81)
compared to the control (∆-DMFS=2.9). In group B a reduction in caries
development of 12 % (∆-DMFS = 2.54) was achieved. The difference in
caries reduction between group A and B was statistically significant.
The combined use of elmex® CARIES PROTECTION toothpaste and weekly brush-in of elmex® gel significantly reduces the occurrence of dental
caries.
References
Mean incremental DMFS values after 2 years
Altenburger MJ, Schirrmeister JF, Wrbas KT, Klasser M,
Hellwig E: Fluoride uptake and remineralization of enamel lesions
after weekly application of differently concentrated fluoride gels.
Δ-DMFS
Madléna et al. 2002
3.5
3
2.5
*
2
1.5
A control group, continued
their usual oral care routine
B elmex® CARIES PROTECTION
toothpaste and placebo gel
C elmex® CARIES PROTECTION
toothpaste and elmex® gel
Caries Res 42 (2008), 312–318
Madléna M, Nagy G, Gábris K, Márton S, Keszthelyi G,
Bárnóczy J: Effect of amine fluoride toothpaste and gel in high risk
groups of Hungarian adolescents: results of a longitudinal study.
Caries Res 36 (2002), 142–146
*p<0.05 vs. control group
1
0.5
0
DMFS
Fig. 2: The combination of elmex® CARIES PROTECTION toothpaste (twice daily) with elmex®
gel (once weekly) reduces significantly the increase of the DMFS scores compared to the
control.
GABA International AG
CH-4106 Therwil, Switzerland
www.gaba.com
03/09
Grabetsmattweg