Tooth WearNCT03197727
Tooth Wear and Associated Risk Factors
A study testing GC Saliva-Check BUFFER in people with Tooth Wear, run by Hacettepe University.
Trial summary
This study compares the associated risk factors between adults with tooth wear and age- and sex-matched controls without tooth wear. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- GC Saliva-Check BUFFER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2014to 18 Jan 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is in good health. Subject is able to understand and read the questionnaire.
Who cannot join
- Wearing orthodontic appliances, Having crowns or partial dentures Using any medications.
About this study
Official title: Evaluation of Tooth Wear and Associated Risk Factors: a Matched Case-control Study
This study compares the associated risk factors between adults with tooth wear and age- and sex-matched controls without tooth wear.
Read the detailed description
Some people are at greater risk due to their eating and brushing habits. Poor oral health behaviors and malnutrition are the leading causes of tooth surface loss in adults. Fluid consumption trends have changed, and the increased consumption of carbonated drinks coincides with a decline in the consumption of dairy products and increases in the use of packaged products. Frequent and faulty brushing with abrasive oral hygiene products can also increase TW. Individuals unhappy with the color of their teeth may also frequently use whitening toothpaste.
Saliva is considered the biological factor with the greatest potential to modify the progression of TW. There are several potential mechanisms by which saliva may protect enamel from dietary acid erosion. Saliva protection mechanisms include the dilution of erosive agents in the mouth, neutralization, effects of calcium and phosphate ions, and slowing of the rate of enamel dissolution.
The loss of dental tissue can lead to the character's loss of precision and form, and in advanced stages the dentin surface can be exposed. TW is initially painless and unrecognizable. In the next stage, complaints often include tenderness and non-aesthetic factors. It is difficult to recognize the signs of TW and very important to avoid premature diagnosis, as TW can often be diagnosed by a dentist. Correct diagnosis is an important part of the treatment and will help the dentist determine recommendations for the patient.
- Conditions
- Tooth Wear
- Being tested
- GC Saliva-Check BUFFER
- Keywords
- Tooth wear, risk factors, saliva, diet, oral hygiene
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC Saliva-Check BUFFERDiagnostic test
Evaluating the saliva flow rate, saliva pH and saliva buffering capacity
| Study group | Role | What they receive |
|---|---|---|
| GC Saliva-Check BUFFER | Other | Saliva test pH Buffering capacity Flow rate Receives: Diagnostic Test: GC Saliva-Check BUFFER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva test
Highly acidic saliva will be in the red section, pH 5.0 - 5.8. Moderately acidic saliva will be found in the yellow section, pH 6.0 - 6.6. Healthy saliva will be in the green section pH 6.8 - 7.8.
Measured: 1 day
Secondary outcomes (1)
Tooth wear
Scoring the tooth wear, Smith and Knight's index (0=No loss of enamel surface characteristics, 1=Loss of enamel surface characteristics, 2=Loss of enamel exposing dentine for less than one third of surface, 3=Loss of enamel exposing dentine for more than one third of the surface, 4=Complete enamel loss, pulp exposure, secondary dentine exposure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start28 Nov 2014
- Primary completion30 Jun 2015
- Study completion18 Jan 2016
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 Tooth WearStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Atalay, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197727
- Sponsor's protocol ID
- GO14/519-01
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fung A, Brearley Messer L. Tooth wear and associated risk factors in a sample of Australian primary school children. Aust Dent J. 2013 Jun;58(2):235-45. doi: 10.1111/adj.12055. Epub 2013 May 5.
PubMed 23713646El Aidi H, Bronkhorst EM, Huysmans MC, Truin GJ. Multifactorial analysis of factors associated with the incidence and progression of erosive tooth wear. Caries Res. 2011;45(3):303-12. doi: 10.1159/000328671. Epub 2011 Jun 8.
PubMed 21654171Zero DT, Lussi A. Erosion--chemical and biological factors of importance to the dental practitioner. Int Dent J. 2005;55(4 Suppl 1):285-90. doi: 10.1111/j.1875-595x.2005.tb00066.x.
PubMed 16167607
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tooth Wear and Associated Risk Factors: a Matched Case-control Study
- ClinicalTrials.gov ID
- NCT03197727
- Acronym / sponsor ID
- GO14/519-01
- Conditions
- Tooth Wear
- Keywords
- Tooth wear, risk factors, saliva, diet, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Nov 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 18 Jan 2016 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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.
This study compares the associated risk factors between adults with tooth wear and age- and sex-matched controls without tooth wear.
Detailed description
Some people are at greater risk due to their eating and brushing habits. Poor oral health behaviors and malnutrition are the leading causes of tooth surface loss in adults. Fluid consumption trends have changed, and the increased consumption of carbonated drinks coincides with a decline in the consumption of dairy products and increases in the use of packaged products. Frequent and faulty brushing with abrasive oral hygiene products can also increase TW. Individuals unhappy with the color of their teeth may also frequently use whitening toothpaste.
Saliva is considered the biological factor with the greatest potential to modify the progression of TW. There are several potential mechanisms by which saliva may protect enamel from dietary acid erosion. Saliva protection mechanisms include the dilution of erosive agents in the mouth, neutralization, effects of calcium and phosphate ions, and slowing of the rate of enamel dissolution.
The loss of dental tissue can lead to the character's loss of precision and form, and in advanced stages the dentin surface can be exposed. TW is initially painless and unrecognizable. In the next stage, complaints often include tenderness and non-aesthetic factors. It is difficult to recognize the signs of TW and very important to avoid premature diagnosis, as TW can often be diagnosed by a dentist. Correct diagnosis is an important part of the treatment and will help the dentist determine recommendations for the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC Saliva-Check BUFFER | Other | Diagnostic Test: GC Saliva-Check BUFFERSaliva test pH Buffering capacity Flow rate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is in good health. Subject is able to understand and read the questionnaire.
Key exclusion criteria (1 listed)
- Wearing orthodontic appliances, Having crowns or partial dentures Using any medications.
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 |
|---|---|---|
| GC Saliva-Check BUFFEREvaluating the saliva flow rate, saliva pH and saliva buffering capacity | Diagnostic test | GC Saliva-Check BUFFER |
Primary outcome
Saliva test
Time frame: 1 day
Highly acidic saliva will be in the red section, pH 5.0 - 5.8. Moderately acidic saliva will be found in the yellow section, pH 6.0 - 6.6. Healthy saliva will be in the green section pH 6.8 - 7.8.
1 secondary outcome
Tooth wear
Time frame: 1 day
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 2017.
- Background: PubMed 23713646Fung A, Brearley Messer L. Tooth wear and associated risk factors in a sample of Australian primary school children. Aust Dent J. 2013 Jun;58(2):235-45. doi: 10.1111/adj.12055. Epub 2013 May 5.
- Background: PubMed 21654171El Aidi H, Bronkhorst EM, Huysmans MC, Truin GJ. Multifactorial analysis of factors associated with the incidence and progression of erosive tooth wear. Caries Res. 2011;45(3):303-12. doi: 10.1159/000328671. Epub 2011 Jun 8.
- Background: PubMed 16167607Zero DT, Lussi A. Erosion--chemical and biological factors of importance to the dental practitioner. Int Dent J. 2005;55(4 Suppl 1):285-90. doi: 10.1111/j.1875-595x.2005.tb00066.x.
- Individual participant dataSharing planned: No
Related trials for Tooth Wear
Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
Not yet recruiting
Applying Navigation and Care to Help Ongoing Retention
Child Obesity
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Not yet recruiting
Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
Wear, Occlusal
Not yet recruiting
PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures
Edentulism Complete, Edentulism
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GC Saliva-Check BUFFER in people with Tooth Wear, run by Hacettepe University.
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 1 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 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Saliva test (time frame: 1 day). 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 NCT03197727, 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 23 Jun 2017.