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Completed

NCT Number: NCT02709824

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Milan

Milan, Italy, 20142

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate with ADS

Drug

Oral rinsing, twice a day, for 21 days

Other names: Curasept (0.12% Chlorhexidine gluconate with ADS)

Chlorhexidine gluconate without ADS

Drug

Oral rinsing, twice a day, for 21 days

Other names: Dentosan (0.12% Chlorhexidine gluconate without ADS)

Primary outcomes

  1. Dental Staining - spectroscopic evaluation

    Time frame: 21 days

    dental color before and after the two treatments

Secondary outcomes

  1. Dental Staining - visual evaluation

    Time frame: 21 days

    dental color before and after the two treatments

  2. Dental Staining - visual evaluation on images

    Time frame: 21 days of treatments, re-analysis of images after 6 months from the end of the trial

    dental color before and after the two treatments

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Acronym: CHX+ADS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2016
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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