Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 24, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedJanuary 18, 2012
January 1, 2012
1 month
June 24, 2011
January 16, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Time point (day) when delta E > 2
11 days
Secondary Outcomes (3)
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
Study Arms (1)
chlorhexidine 0.12 %
EXPERIMENTALInterventions
twice daily, 10 ml, topical
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Saxony, 01307, Germany
Related 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. doi: 10.1111/j.1600-0765.1979.tb00238.x. No abstract available.
PMID: 161782BACKGROUNDBengel 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.
PMID: 15000901BACKGROUNDDenissen H, Dozic A. Photometric assessment of tooth color using commonly available software. Eur J Esthet Dent. 2010 Summer;5(2):204-15.
PMID: 20589263BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Hoffmann, Prof. Dr.
Technische Universität Dresden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2011
First Posted
June 27, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 18, 2012
Record last verified: 2012-01