The present study aims at testing whether the 0.07% CPC-mouthrinse has a potential to inhibit gingival inflammation as compared to a placebo over a 6 month period.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gingivitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quigley & Hein plaque index
Secondary outcome
Bleeding on marginal probing index, Staining index and VAS-questionnaire
Background summary
Maintaining an adequate low level of plaque through daily tooth brushing is
often not feasible. Chemotherapeutic agents as an adjunct to mechanical plaque
control would be valuable. Cetylpyridinium chloride (CPC) has proven to be an
effective inhibitor of plaque accumulation.
Study objective
The present study aims at testing whether the 0.07% CPC-mouthrinse has a
potential to inhibit gingival inflammation as compared to a placebo over a 6
month period.
Study design
This study is designed as a double examiner-blind, 2-group cross-over. Subjects
will receive a unique trial number and will be randomly assigned to one of the
2 groups according to a Latin square design. On the 1st appointment plaque
accumulation, gingivitis and staining will be scored. After completion of the
clinical assessments a dental hygienist will provide a professional dental
scale and polish. Each subject will receive a written and verbal instruction
about how to use the mouthrinse. The subjects will also receive a standard
toothbrush and toothpaste to brush 3 times a day. All subjects are instructed
to use their allocated products 3 times a day. At this moment subjects will
rinse for the first time with their allocated mouthrinse. After 3 and 6 months,
subjects return to the clinic for the clinical assessments. Subsequently all
subjects receive a questionnaire to evaluate their attitude towards the used
products using Visual Analogue Scales (VAS-scores).
Intervention
During 6 months subjects have to rinse 3 a day with CPC-mouthrinse or a placebo
mouthrinse.
Study burden and risks
No
Louwesweg 1
1066 EA AMSTERDAM
NEDERLAND
Louwesweg 1
1066 EA AMSTERDAM
NEDERLAND
Listed location countries
Age
Inclusion criteria
-*18 years of age, -a minimum of 5 evaluable teeth in each quadrant (with no partial dentures, orthodontic banding or wires)
Exclusion criteria
-oral lesions and/or periodontal pockets >5 mm - pregnancy or systemic diseases such as diabetes
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 | NL27846.018.09 |