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Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382914
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
The purpose of this study is to daily monitor the discoloration of teeth when participants rinse with a mouth rinse and black tea and to determine the time point when unacceptable discoloration occurs.

Condition or disease Intervention/treatment Phase
Discoloration of Teeth Other: chlorhexidine 0.12% Not Applicable

Detailed Description:
Tooth discoloration is a side effect of most mouth rinse solutions. It impairs the aesthetic appearance especially of the front teeth. The aim of this pilot study is to determine a time point when visible discoloration appears in the front teeth. Therefore, participants of this study will rinse twice daily with chlorhexidine mouth rinse for 10 days. To elicit a more pronounced discoloration, participants will rinse with black tea right after the chlorhexidine rinse. Discoloration will be measured daily by discoloration index, by spectrophotometry, and by the use of a digital photo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
Study Start Date : April 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: chlorhexidine 0.12 % Other: chlorhexidine 0.12%
twice daily, 10 ml, topical
Other Name: Perio-Aid 0.12%

Primary Outcome Measures :
  1. Time point (day) when delta E > 2 [ Time Frame: 11 days ]

Secondary Outcome Measures :
  1. Time point (day) when discoloration index changes compared to baseline [ Time Frame: 11 days ]
  2. Time point (day) when changes in the photo evaluation occur compared to baseline [ Time Frame: 11 days ]
  3. Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline [ Time Frame: 11 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • persons aged 18 to 30 years
  • written informed consent
  • healthy participants
  • participants who have no or mild gingivitis
  • participants who have all incisors and canines in the upper and lower jaw

Exclusion Criteria:

  • participants who have severe general diseases
  • participants who have allergies against the ingredients of the mouthrinse
  • participants who are enrolled in another clinical study
  • participants who are not able to oversee the consequences of the study
  • female participants who are pregnant or breast feeding
  • participants who have impaired compliance
  • participants who have moderate or severe gingivitis
  • participants who have fillings in the incisors and canines
  • participants who smoke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382914

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Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
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Principal Investigator: Thomas Hoffmann, Prof. Dr. Technische Universität Dresden
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Responsible Party: Technische Universität Dresden Identifier: NCT01382914    
Other Study ID Numbers: PAR01-2011
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents