Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

Conditions
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Discoloration of Teeth

Intervention / Treatment
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* Other: chlorhexidine 0.12%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine 0.12 %<br> | Other: chlorhexidine 0.12%<br>* twice daily, 10 ml, topical<br>* Other names: Perio-Aid 0.12%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time point (day) when delta E > 2 |  | 11 days | 

Secondary Outcome Measures

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