Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

January 16, 2012 updated by: Technische Universität Dresden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chlorhexidine 0.12 %
Other: chlorhexidine 0.12%
twice daily, 10 ml, topical
Other Names:
  • Perio-Aid 0.12%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time point (day) when delta E > 2
Time Frame: 11 days
11 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time point (day) when discoloration index changes compared to baseline
Time Frame: 11 days
11 days
Time point (day) when changes in the photo evaluation occur compared to baseline
Time Frame: 11 days
11 days
Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline
Time Frame: 11 days
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR01-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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