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Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01382914
First received: June 24, 2011
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Discoloration of Teeth
 Other: chlorhexidine 0.12%

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • Time point (day) when delta E > 2 [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time point (day) when discoloration index changes compared to baseline [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Time point (day) when changes in the photo evaluation occur compared to baseline [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: April 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chlorhexidine 0.12 % Other: chlorhexidine 0.12%
twice daily, 10 ml, topical
Other Name: Perio-Aid 0.12%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382914

Locations
Germany
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Thomas Hoffmann, Prof. Dr. Dresden University of Technology
  More Information

Publications:

Responsible Party: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01382914     History of Changes
Other Study ID Numbers: PAR01-2011
Study First Received: June 24, 2011
Last Updated: January 16, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013