Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

Discoloration of Teeth Clinical Trial

Official title:

Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382914
• Other study ID #: PAR01-2011
• Status: Completed
• Phase: N/A
• First received: June 24, 2011
• Last updated: January 16, 2012
• Start date: April 2011
• Est. completion date: May 2011

Study information

• Verified date: January 2012
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Discoloration of Teeth
• Tooth Discoloration

Intervention

Other:
• chlorhexidine 0.12%
twice daily, 10 ml, topical

Locations

Country	Name	City	State
Germany	Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie	Dresden	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View Citation

Denissen H, Dozic A. Photometric assessment of tooth color using commonly available software. Eur J Esthet Dent. 2010 Summer;5(2):204-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time point (day) when delta E > 2		11 days	No
Secondary	Time point (day) when discoloration index changes compared to baseline		11 days	No
Secondary	Time point (day) when changes in the photo evaluation occur compared to baseline		11 days	No
Secondary	Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline		11 days	No