Recently, a chlorhexidine product with an anti-discoloration system (ADS) was launched in the market. A comparative study was done to confirm the effectiveness of 0.2% chlorhexidine with ADS. The study was single-blinded. In the experimental period, volunteers maintained their usual oral hygiene habits, besides, they rinsed twice daily with mouthwash (0.2% chlorhexidine) with or without ADS. Obviously, subject's home oral hygiene may become a major confounder of plaque accumulation. Although the effect of ADS is statistically significant, the ability of this new product to prevent plaque accumulation and gingivitis remained highly questionable.
Hence, controversy exists about the clinical efficacy of the chlorhexidine products with ADS. Consequently, a clinical validation of such products appears necessary. In the present study, the 21-day experimental gingivitis model will be used. This model is an established non-invasive model in humans for investigating the induction and resolution of inflammation in response to increasing bacterial accumulation. The design enables a study to be performed over 35 days in a well-controlled manner. So far, it is the most accurate clinical study model to access how medication or compounds in dentifrices affect plaque accumulation and gingival inflammation.
systemically healthy,
non-smoker, former smokers > 5 years,
at least 24 teeth,
clinical diagnosis of periodontal health or gingivitis as determined by pocket probing depth not exceeding 4 mm with concomitant bleeding on probing.
clinically visible carious lesions,
systemic antibiotics within 3 months prior to enrolment
vulnerable persons
Parallel
Experimental gingivitis model
Other interventionParticipants will abolish all measures for mechanical plaque control for a period of 3 weeks according to the experimental gingivitis model.
Severity of gingival inflammation, assessed by the Gingival Index by Löe and Silness 1963
The index is a scoring system 0, 1, 2, or 3 where 0 is defining normal gingiva to 3 representing severe inflammation with spontaneous bleeding
Severity of gingival inflammation, assessed by the Gingival Index by Löe and Silness 1963
The index is a scoring system 0, 1, 2, or 3 where 0 is defining normal gingiva to 3 representing severe inflammation with spontaneous bleeding
Plaque accumulation, assessed by the Plaque Index Silness and Löe 1994
The index is a scoring system assessing the plaque at 4 surfaces of the teeth, starting at 0 for no plaque visible to 3 with an abundance of plaque creating a thick layer that fills the interdental space.
Staining assessed by the Discoloration index
The discoloration is an index from 0: no discoloration to 3: Heavy brown and black discoloration over the entire extent of the tooth surface, black discoloration predominantly on the interproximal surfaces
Oral scan
Oral scans will be performed to study changes in gingival texture, volume and colour or other changes
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