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

Adverse Effect Clinical Trial

— CHX+ADS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709824
• Other study ID #: ADS2012
• Status: Completed
• Phase: N/A
• First received: March 11, 2016
• Last updated: March 11, 2016
• Start date: December 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2016
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• a subject had to be free from oral mucosa conditions affecting its integrity and to avoid drug or mouthwash intake during the study and in the previous month (eligibility criteria).

Exclusion Criteria:

• specific allergy to mouthrinses, presence of periodontitis, and frequent use of CHX-based oral hygiene products.

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

Intervention

Drug:
• Chlorhexidine gluconate with ADS
Oral rinsing, twice a day, for 21 days
• Chlorhexidine gluconate without ADS
Oral rinsing, twice a day, for 21 days

Locations

Country	Name	City	State
Italy	University of Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Solís 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Staining - spectroscopic evaluation	dental color before and after the two treatments	21 days	No
Secondary	Dental Staining - visual evaluation	dental color before and after the two treatments	21 days	No
Secondary	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	No