Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

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


Further study details as provided by Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
Investigators
Principal Investigator: Thomas Hoffmann, Prof. Dr. Technische Universität Dresden
  More Information

Publications:
Responsible Party: Technische Universität Dresden
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
Stomatognathic Diseases
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014