Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)
Condition: Adverse Effect
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Chlorhexidine gluconate with ADS; Chlorhexidine gluconate without ADS
Intervention type(s): Drug; Drug
Intervention description(s): Oral rinsing, twice a day, for 21 days; Oral rinsing, twice a day, for 21 days
Other intervention name(s): Curasept (0.12% Chlorhexidine gluconate with ADS); Dentosan (0.12% Chlorhexidine gluconate without ADS)
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)