Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

Not Applicable

Completed

• Conditions: Discoloration of Teeth
• Interventions: Other: chlorhexidine 0.12%

• Registration Number: NCT01382914
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

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 Timeline

• Study Start: 2011-04
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chlorhexidine 0.12 %	chlorhexidine 0.12%	-

Primary Outcome Measures

Name	Time	Method
Time point (day) when delta E > 2	11 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie; 🇩🇪 Dresden, Sachsen, Germany