University of Milan
Milan, Italy, 20142
NCT Number: NCT02709824
Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.
A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A wash-out period between the cycles of 21 days will be performed.
In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration will be obtained by means of clinical photograph visual analysis and new questionnaires.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Milan, Italy, 20142
In the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L*a*b* data analysis with DeltaE evaluation) and questionnaire-based analyses will be recorded. Immediate visual analysis of tooth pigmentation will be evaluated by volunteer him/herself, using a mirror, and by a single dentist soon after the end of each treatment. Participants will indicate the presence/absence of dental pigmentation, and to quantify it with a numeric scale (0= no pigmentation to 10= very strong pigmentation).
These analyses will be performed at baselines and after each 21-days-long cycle of mouthwash.
A wash-out period between the cycles of 21 days will be performed. In the second "late" phase, a long-term subjective evaluation of dental discoloration will be obtained by means of the visual analysis of clinical photograph and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental images of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, as well as by 14 dentists and 13 oral hygienists ad hoc recruited. Dentists and oral hygienists, in particular, will be asked to observe two images of all the 22 subjects, i.e. after treatment with A or B mouthwash, and to answer to the question: "Which picture shows the most pigmented teeth?" Possible answers will be: "A, or B or no difference between the two images". Pigmentation will be also quantified using the numeric scale (0= no pigmentation to 10=strong pigmentation).
The observer will be not instructed in how the color of the teeth should appear in case of CHX pigmentation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral rinsing, twice a day, for 21 days
Other names: Curasept (0.12% Chlorhexidine gluconate with ADS)
Oral rinsing, twice a day, for 21 days
Other names: Dentosan (0.12% Chlorhexidine gluconate without ADS)
Time frame: 21 days
dental color before and after the two treatments
Time frame: 21 days
dental color before and after the two treatments
Time frame: 21 days of treatments, re-analysis of images after 6 months from the end of the trial
dental color before and after the two treatments
University of Milan
Other
Efficacy of an Anti-Discoloration System (ADS) to Reduce Dental Staining in a 0.12% Chlorhexidine-based Mouthwash
Acronym: CHX+ADS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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