Dentin HypersensitivityNCT00926484
Tooth Mousse and Fluoride in Dentin Hypersensitivity Treatment
An observational study of Dentin Hypersensitivity, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries progression. Read more about this study
- Who is it for?
- Ages 26 to 66 years
- Conditions the study is for
- Dentin Hypersensitivity
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jun 2008
- Phase
- Observational
- 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 26 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- subjects with a minimum of three cervical hypersensitive teeth at both sides of the dental arch
Who cannot join
- dentin hypersensitivity caused by caries lesions
- fracture of restoration
- chipped teeth
- marginal gaps
- post-operative sensitivity
- cracked-tooth syndrome, and which were confirmed by periapical radiographs and teeth with cervical fillings
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Combined Tooth Mousse and Fluoride Varnish in Dentin Hypersensitivity Treatment
GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries progression. Whether CPP-ACP can act synergistically with fluorine in the dentin hypersensitivity treatment is unknown. The aim of this study was to assess the effect of CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin hypersensitivity, Tooth Mousse, fluoride varnish
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tooth Mousse | Not described | |
| fluoride varnish | Not described | |
| Tooth Mousse + fluoride varnish | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANOVA
Measured: June 2008
Secondary outcomes (1)
T-test
Measured: June 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Investigators
- Xuejin Tao, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926484
- Sponsor's protocol ID
- TF87330244
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kowalczyk A, Botulinski B, Jaworska M, Kierklo A, Pawinska M, Dabrowska E. Evaluation of the product based on Recaldent technology in the treatment of dentin hypersensitivity. Adv Med Sci. 2006;51 Suppl 1:40-2.
PubMed 17458057
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Tooth Mousse and Fluoride Varnish in Dentin Hypersensitivity Treatment
- ClinicalTrials.gov ID
- NCT00926484
- Acronym / sponsor ID
- TF87330244
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin hypersensitivity, Tooth Mousse, fluoride varnish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Jun 2009 (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.
GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries progression. Whether CPP-ACP can act synergistically with fluorine in the dentin hypersensitivity treatment is unknown. The aim of this study was to assess the effect of CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tooth Mousse | – | – |
| fluoride varnish | – | – |
| Tooth Mousse + fluoride varnish | – | – |
Who may qualify
- Ages
- 26 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- subjects with a minimum of three cervical hypersensitive teeth at both sides of the dental arch
Key exclusion criteria (6 listed)
- dentin hypersensitivity caused by caries lesions
- fracture of restoration
- chipped teeth
- marginal gaps
- post-operative sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ANOVA
Time frame: June 2008
1 secondary outcome
T-test
Time frame: June 2008
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 23 Jun 2009.
- Background: PubMed 17458057Kowalczyk A, Botulinski B, Jaworska M, Kierklo A, Pawinska M, Dabrowska E. Evaluation of the product based on Recaldent technology in the treatment of dentin hypersensitivity. Adv Med Sci. 2006;51 Suppl 1:40-2.
- Treating cervical dentin hypersensitivity with fluoride varnish: a randomized clinical study.Link provided by the sponsor.
- definition of Dentine hypersensitivityLink provided by the sponsor.
- Prevalence and distribution of cervical dentin hypersensitivity in a population in Taipei, TaiwanLink provided by the sponsor.
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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.
Xuejin Tao, Doctor study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentin Hypersensitivity, run by Huazhong University of Science and Technology at 1 site in China.
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 1 inclusion and 6 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 23 Jun 2009. 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 China. 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?
ANOVA (time frame: June 2008). 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 NCT00926484, which also lists 1 linked publication.
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 23 Jun 2009.