The aim of the present study was to evaluate the potential of a dentifrice with natural ingredients (Aronal®) to inhibit gingivitis development over a period of 4 months.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gingivitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
by standardized measurements and score procedures determine the effect of the
oral hygiene procedure on levels of plaque and gingival abrasion over the
evaluation period.
Secondary outcome
nvt
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. In spite of the activity in improving toothbrush type
and design, most people still remove only approximately 50% of the plaque
present when they brush their teeth (Jepsen 1998). The development of a
dentifrice that would allow the average person to control plaque and gingivitis
would be desirable.
Study objective
The aim of the present study was to evaluate the potential of a dentifrice with
natural ingredients (Aronal®) to inhibit gingivitis development over a period
of 4 months.
Study design
The study is designed to evaluate the effect of a dentifrice with natural
ingredients over a period of 4 months. 80 subjects (non-dental) will be
selected on the basis of having moderate gingival inflammation. The single
blind study consists of 2 phases: a pre-experimental phase of 3 weeks and an
experimental period of 4 months. At the start of the pre-experimental phase
gingivitis (MGI) bleeding upon marginal probing (BOMP) and plaque (Quigley &
Hein) will be assessed. Subjects receive a written instruction in the use of a
manual toothbrush. Furthermore, a combination of Bocasan® and chlorhexidine
0.20% will be used to rinse 2 times per day during the 3 weeks prior to the
second fase of the experiment. The baseline assessment is scheduled 3 weeks
later. Subjects are randomly assigned to one of 2 groups (test & control). All
will be instructed to brush their teeth with their assigned toothpaste for 2
minutes 2 times a day using the timer. Clinical examinations will be performed
after 4 months. All parameters assessed at the start of the study are evaluated
after 4 months.
Intervention
Improvement of gingival health by removing plaque and avoiding gingival
abrasion with the manual toothbrush and a toothpaste with natural ingredients.
Study burden and risks
Risk for subjects: none.
Emil Frey-Strasse 100
4142 Münchenstein
Switzerland
Emil Frey-Strasse 100
4142 Münchenstein
Switzerland
Listed location countries
Age
Inclusion criteria
At least 5 evaluable teeth in each quadrant
Moderate gingivitis (*40% bleeding on marginal probing),
Exclusion criteria
No partial dentures, orthodontic banding or wires.
No oral lesions or periodontal pockets *5mm
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14928.018.06 |