The effect of application of 0.12% chlorhexidine gel-toothpaste compared to 0.12% chlorhexidine mouthwash and regular toothpaste in a 3 day non-brushing model on plaque accumulation.

Background:

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. Lower concentrations of chlorhexidine might decrease the chances for adverse effects.



Aim:

The purpose of the study is to assess the effect of tray application of 0.12% chlorhexidine gel-toothpaste on ¡®de novo¡¯ plaque accumulation compared to the effect of rinsing with 0.12% chlorhexidine mouthwash and tray application of a regular toothpaste in a 3 day non-brushing model.




Material and methods:

The study is designed as a single blind, randomized 3-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 0.12% chlorhexidine. One group will use a regular toothpaste twice daily also applied with a fluoride tray. One group will use 0.12% chlorhexidine mouthwash, rinsing twice daily with 15 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.




Population:

90 Subjects, >18 years, systemically healthy, with at least 5 teeth per quadrant and no pockets >5 mm, no orthodontic appliance or removable (partial) denture





Intervention:

Tray application of 0.12% chlorhexidine gel-toothpaste twice daily during 2 minutes or tray application of regular toothpaste twice daily during 2 minutes or tray or rinsing with 0.12% chlorhexidine mouthwash twice daily during 1 minute, during a 3 days non-brushing period.




Time load for subjects:

Maximum 4 minutes of product uses per day during 3 days and a total of 40 minutes professional prophylaxis and clinical assessment.




Risk for subjects:

None.



Endpoint:

Quigley & Hein plaque index assessed after 3 days of ¡®de novo¡¯ plaque accumulation.

Tray application of 0.12% chlorhexidine gel-toothpaste has more than 15% better effect
on ¡®de novo¡¯ plaque accumulation compared to tray application of regular toothpaste in a 3 day non-brushing model.

N/A

Tray application of 0.12% chlorhexidine gel-toothpaste twice daily during 2 minutes or tray application of regular toothpaste twice daily during 2 minutes or rinsing with 0.12% chlorhexidine mouthwash twice daily during 1 minute, during a 3 day non-brushing period.