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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adverse Effect

Intervention / Treatment
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* Drug: Chlorhexidine gluconate with ADS
* Drug: Chlorhexidine gluconate without ADS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: to be free from oral mucosa conditions affecting its integrity to avoid drug or mouthwash intake during the study and in the previous month Exclusion Criteria: specific allergy to mouthrinses presence of periodontitis frequent use of Chlorhexidine-based oral hygiene products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine gluconate with ADS<br>Chlorhexidine 0.12% plus Anti-Discoloration System Mouthwash | Drug: Chlorhexidine gluconate with ADS<br>* Oral rinsing, twice a day, for 21 days<br>* Other names: Curasept (0.12% Chlorhexidine gluconate with ADS);|
| Active Comparator: Chlorhexidine gluconate without ADS<br>Chlorhexidine 0.12% Mouthwash | Drug: Chlorhexidine gluconate without ADS<br>* Oral rinsing, twice a day, for 21 days<br>* Other names: Dentosan (0.12% Chlorhexidine gluconate without ADS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Staining - spectroscopic evaluation | dental color before and after the two treatments | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Staining - visual evaluation | dental color before and after the two treatments | 21 days | 
| Dental Staining - visual evaluation on images | dental color before and after the two treatments | 21 days of treatments, re-analysis of images after 6 months from the end of the trial |