The primary objective of the present trial is to evaluate, during a 4-week period, the efficacy of a Zendium dentifrice containing enzymes, colostrum, lysozyme & zinc, in combination with the use of a manual toothbrush with respect to plaque…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Tandvleesontsteking (gingivitis)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
BOMP (bleeding on marginal probing) Van der Weijden 1994
Plaque (Quigle & Hein)
Secondary outcome
VAS Questionnaire about the used product
Background summary
Control of plaque on the tooth surfaces is the most important method of
controlling dental disease. A manual toothbrush is the most popular mechanical
method of plaque control. This non-specific control of the periodontal
microbiota is effective in the majority of cases where access to the plaque
deposits is possible (Listgarten 1988). In spite of the activity in improving
toothbrush type and design, most people reduce plaque scores only with
approximately 50% when they brush their teeth (Jepsen 1998). The development of
a dentifrice that would allow the average person in helping to control plaque
and gingivitis would be desirable
Study objective
The primary objective of the present trial is to evaluate, during a 4-week
period, the efficacy of a Zendium dentifrice containing enzymes, colostrum,
lysozyme & zinc, in combination with the use of a manual toothbrush with
respect to plaque removing efficacy, plaque growth inhibition, and effect on
gingival inflammation.
Study design
This study is designed as double blind, 4-group parallel, 30-day home use
experiment.
Subjects will be randomly assigned to one of 4 groups. They will recevide there
allocated product wich they will use for the next 30 days. Baseline, halve way
and the end of 30 days the condition of the gingiva will be evaluated.
Intervention
Zendium dentifrice
Study burden and risks
Risk for subjects: none.
Gustav Mahlerlaan 3004
1081 LA
NL
Gustav Mahlerlaan 3004
1081 LA
NL
Listed location countries
Age
Inclusion criteria
* * 18 years * Systemically healthy * minimum 5 teeth per quandrant * moderate gingivtis ( 40% bleeding on marginal probing) * not participate in other oral clinical care study * an absence of oral lesions and/or periodontal pockets * 5 mm
Exclusion criteria
* the absence of pregnancy and systemic diseases such as aids, cirrhosis, diabetes * the absence of any adverse medical history or long-term medication * or any physical condition that limits manual dexterity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33561.018.10 |
| OMON | NL-OMON27210 |