drugset / Trial / NCT02709824

Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)

NCT02709824

Completed 22 enrolled University of Milan
RandomizedCrossoverQuadruple-blind

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.

Timeline

Start
2011-12
Primary completion
2012-02
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorhexidine gluconate Other / unclassified 0.12 % Oral

Indications

No indication recorded.