Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)
NCT ID: NCT02709824
Last Updated: 2016-03-22
Study Results
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Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2011-12-31
2012-07-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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Chlorhexidine gluconate with ADS
Chlorhexidine 0.12% plus Anti-Discoloration System Mouthwash
Chlorhexidine gluconate with ADS
Oral rinsing, twice a day, for 21 days
Chlorhexidine gluconate without ADS
Chlorhexidine 0.12% Mouthwash
Chlorhexidine gluconate without ADS
Oral rinsing, twice a day, for 21 days
Interventions
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Chlorhexidine gluconate with ADS
Oral rinsing, twice a day, for 21 days
Chlorhexidine gluconate without ADS
Oral rinsing, twice a day, for 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* to avoid drug or mouthwash intake during the study and in the previous month
Exclusion Criteria
* presence of periodontitis
* frequent use of Chlorhexidine-based oral hygiene products
18 Years
40 Years
ALL
Yes
Sponsors
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University of Milan
OTHER
Responsible Party
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ANDREA SARDELLA
Associate Professor
Principal Investigators
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Antonio Carrassi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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University of Milan
Milan, Italy, Italy
Countries
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References
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Cortellini P, Labriola A, Zambelli R, Prato GP, Nieri M, Tonetti MS. Chlorhexidine with an anti discoloration system after periodontal flap surgery: a cross-over, randomized, triple-blind clinical trial. J Clin Periodontol. 2008 Jul;35(7):614-20. doi: 10.1111/j.1600-051X.2008.01238.x. Epub 2008 Apr 16.
Bernardi F, Pincelli MR, Carloni S, Gatto MR, Montebugnoli L. Chlorhexidine with an Anti Discoloration System. A comparative study. Int J Dent Hyg. 2004 Aug;2(3):122-6. doi: 10.1111/j.1601-5037.2004.00083.x.
Solis C, Santos A, Nart J, Violant D. 0.2% chlorhexidine mouthwash with an antidiscoloration system versus 0.2% chlorhexidine mouthwash: a prospective clinical comparative study. J Periodontol. 2011 Jan;82(1):80-5. doi: 10.1902/jop.2010.100289. Epub 2010 Jul 27.
Li W, Wang RE, Finger M, Lang NP. Evaluation of the antigingivitis effect of a chlorhexidine mouthwash with or without an antidiscoloration system compared to placebo during experimental gingivitis. J Investig Clin Dent. 2014 Feb;5(1):15-22. doi: 10.1111/jicd.12050. Epub 2013 Jun 14.
Other Identifiers
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ADS2012
Identifier Type: -
Identifier Source: org_study_id
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