Discoloration of TeethNCT01382914
Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
A study testing chlorhexidine 0.12% in people with Discoloration of Teeth, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration of Teeth
- What is being tested?
- chlorhexidine 0.12%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- participants who have moderate or severe gingivitis
- participants who have fillings in the incisors and canines
- participants who smoke
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Saxony, 01307
About this study
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.
Read the 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.
- Conditions
- Discoloration of Teeth
- Being tested
- chlorhexidine 0.12%
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine 0.12%Other
Also called Perio-Aid 0.12%
twice daily, 10 ml, topical
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine 0.12 % | Experimental | Not described Receives: Other: chlorhexidine 0.12% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time point (day) when delta E > 2
Measured: 11 days
Secondary outcomes (3)
Time point (day) when discoloration index changes compared to baseline
Measured: 11 days
Time point (day) when changes in the photo evaluation occur compared to baseline
Measured: 11 days
Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Discoloration of TeethStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Hoffmann, Prof. Dr., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382914
- Sponsor's protocol ID
- PAR01-2011
- Status last verified
- Jan 2012
- First submitted
- 24 Jun 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 161782Bengel 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.
PubMed 15000901Denissen H, Dozic A. Photometric assessment of tooth color using commonly available software. Eur J Esthet Dent. 2010 Summer;5(2):204-15.
PubMed 20589263
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
- ClinicalTrials.gov ID
- NCT01382914
- Acronym / sponsor ID
- PAR01-2011
- Conditions
- Discoloration of Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine 0.12 % | Experimental | Other: chlorhexidine 0.12% |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorhexidine 0.12%Also: Perio-Aid 0.12%twice daily, 10 ml, topical | Other | chlorhexidine 0.12 % |
Primary outcome
Time point (day) when delta E > 2
Time frame: 11 days
3 secondary outcomes
Time point (day) when discoloration index changes compared to baseline
Time frame: 11 days
Time point (day) when changes in the photo evaluation occur compared to baseline
Time frame: 11 days
Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline
Time frame: 11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Background: PubMed 161782Addy 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.
- Background: PubMed 15000901Bengel 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.
- Background: PubMed 20589263Denissen H, Dozic A. Photometric assessment of tooth color using commonly available software. Eur J Esthet Dent. 2010 Summer;5(2):204-15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hoffmann, Prof. Dr. principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chlorhexidine 0.12% in people with Discoloration of Teeth, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time point (day) when delta E > 2 (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01382914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.