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

Adverse Effect Clinical Trial

Official title: Efficacy of an Anti-Discoloration System (ADS) to Reduce Dental Staining in a 0.12% Chlorhexidine-based Mouthwash

Status Completed

Clinical Trial 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 ADS. Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, we record the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses, at baselines and after each 21 days long-cycle of mouthwash. A wash-out period between the cycles of 21 days is performed.

In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration was obtained by means of clinical photograph visual analysis and new questionnaires.

Clinical Trial Description

In the first phase, we will record the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L*a*b* data analysis with DeltaE evaluation) and questionnaire-based analyses. 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. They 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 clinical photograph visual analysis and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental photographs of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Adverse Effect

• NCT number: NCT02709824
• Study type: Interventional
• Source: University of Milan
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Completion date: July 2012