Clinical trial NCT01382914: Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
Official title: Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discoloration of Teeth
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Time point (day) when delta E > 2
timeFrame: 11 days
Secondary outcomes:
measure: Time point (day) when discoloration index changes compared to baseline
timeFrame: 11 days
measure: Time point (day) when changes in the photo evaluation occur compared to baseline
timeFrame: 11 days
measure: Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline
timeFrame: 11 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
state: Sachsen
Study officials:
affiliation: Technische Universität Dresden
name: Thomas Hoffmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Addy M, Prayitno S, Taylor L, Cadogan S. An in vitro study of the role of dietary factors in the aetiology of tooth staining associated with the use of chlorhexidine. J Periodontal Res. 1979 Sep;14(5):403-10. doi: 10.1111/j.1600-0765.1979.tb00238.x. No abstract available.
citation: Bengel WM. Digital photography and the assessment of therapeutic results after bleaching procedures. J Esthet Restor Dent. 2003;15 Suppl 1:S21-32; discussion S32. doi: 10.1111/j.1708-8240.2003.tb00315.x.
citation: Denissen H, Dozic A. Photometric assessment of tooth color using commonly available software. Eur J Esthet Dent. 2010 Summer;5(2):204-15.