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Completed

NCT Number: NCT01382914

Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

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.

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Key information

Conditions

Discoloration of Teeth Stomatognathic Diseases Tooth Discoloration Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

chlorhexidine 0.12%

Other

twice daily, 10 ml, topical

Other names: Perio-Aid 0.12%

Primary outcomes

  1. Time point (day) when delta E > 2

    Time frame: 11 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Jan 18, 2012

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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