The aim of this study is to assess the effect of the CrossAction ProHealth toothbrush and the Advantage 123 toothbrush on gingival bleeding in a group of subjects who have been allowed to develop gingivitis by abstaining from oral hygiene for 21…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gingivitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bleeding on Marginal Probing (BOMP) * Angular Bleeding Index
Secondary outcome
Quigley & Hein Plaque index
Background summary
The important relationship between the presence of plaque and the development
of gingivitis was first proven in an experimental gingivitis study published in
1965 by Löe, Theilade and Jensen. In their study, subjects were allowed to
neglect their oral hygiene and develop gingivitis, but once thorough
toothbrushing was reinstated there was a rapid return to a plaque free
condition that was followed within 5 days by a return to a gingival condition
that was classified as healthy. Thus the importance of plaque control in the
overall maintenance of good oral hygiene was established.
Study objective
The aim of this study is to assess the effect of the CrossAction ProHealth
toothbrush and the Advantage 123 toothbrush on gingival bleeding in a group of
subjects who have been allowed to develop gingivitis by abstaining from oral
hygiene for 21 days.
Study design
The study is designed as a two treatment, examiner-blind, randomized,
experimental gingivitis, split-mouth design study. A 3-week non-brushing period
(experimental gingivitis) will be introduced to standardize the level of
gingivitis inflammation at the start of the actual experiment. This model will
assess the reduction of gingivitis after this 3-week experimental gingivitis
(EG) period comparing 2 manual brushes in a split-mouth design.
Intervention
Brushing with 2 different manual toothbrushes in a experimental gingivitis
model.
Study burden and risks
none
8700 Mason-Montgomery Road
Mason, OH 45040
U.S.A.
8700 Mason-Montgomery Road
Mason, OH 45040
U.S.A.
Listed location countries
Age
Inclusion criteria
*Be between the ages of 18 and 70,
*Be in good general health as determined by the investigator/designee based on a review of the medical history/update,
*Possess at least 5 evaluable teeth in each quadrant in the lower jaw,
*Be a non-smoker,
*Have a > 25% level of bleeding,
*Be right handed.
Exclusion criteria
*Orthodontic banding or wires or partial dentures,
*Severe periodontal disease (no sites with PPD > 5mm), including but not limited to purulent exudate, generalized mobility, and or severe recession,
*Any disease or conditions that could be expected to interfere with examination procedures or the subject safely completing the trial.
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 | NL20496.018.07 |