Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth

NCT ID: NCT01382914

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-05-31

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.

Conditions

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Discoloration of Teeth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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chlorhexidine 0.12 %

Group Type EXPERIMENTAL

chlorhexidine 0.12%

Intervention Type OTHER

twice daily, 10 ml, topical

Interventions

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chlorhexidine 0.12%

twice daily, 10 ml, topical

Intervention Type OTHER

Other Intervention Names

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Perio-Aid 0.12%

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Hoffmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

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Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 161782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15000901 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20589263 (View on PubMed)

Other Identifiers

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PAR01-2011

Identifier Type: -

Identifier Source: org_study_id

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