The purpose of the study is to assess the effect of tray application of 1% chlorhexidine gel on *de novo* plaque accumulation compared to the effect of 0.12% chlorhexidine gel-toothpaste or a regular toothpaste tray application or rinsing with 0.2%…
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 assessed after 3 days of *de novo* plaque
accumulation.
Secondary outcome
Bleeding on marginal probing 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. Chlorhexidine has proven to be an effective
inhibitor of plaque accumulation.
Study objective
The purpose of the study is to assess the effect of tray application of 1%
chlorhexidine gel on *de novo* plaque accumulation compared to the effect of
0.12% chlorhexidine gel-toothpaste or a regular toothpaste tray application or
rinsing with 0.2% chlorhexidine mouthwash in a 3 day non-brushing model.
Study design
The study is designed as a single blind, randomized 4-arm parallel clinical
trial. During a 3 day non brushing period, one group will use gel twice daily
applied with a fluoride tray. This gel contains 1% chlorhexidine. One group
will use 0.12% chlorhexidine gel-toothpaste and one group a regular toothpaste
twice daily also applied with a fluoride tray. One group will 0. 2%
chlorhexidine mouthwash, rinsing twice daily with 10 ml. 3 Days later all
subject will return. After disclosing, plaque accumulation is scored.
Subsequently all subjects receive a questionnaire to evaluate their attitude
towards the used products using Visual Analogue Scales (VAS-scores). After the
experimental period, habitual oral hygiene procedures may be resumed.
Intervention
Tray application of 1% chlorhexidine gel or 0.12% chlorhexidine gel-toothpaste
or regular toothpaste twice daily during 2 minutes or rinsing with 0.2%
chlorhexidine mouthwash twice daily during 1 minute, during a 3 days
non-brushing period.
Study burden and risks
Risk for subjects: None
Louwesweg 1
1066 EA Amsterdam
Nederland
Louwesweg 1
1066 EA Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
* * 18 years
* Systemically healthy
* * 20 teeth
* 5 teeth per quadrant
* No pockets >5 mm.
* No orthodontic appliances
* No removable (partial) dentures
Exclusion criteria
* Use of medication possibly influencing normal gingival health
* Pregnancy
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 | NL18362.018.07 |