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CompletedNCT03197727Updated Jun 23, 2017

Tooth Wear and Associated Risk Factors

An interventional study of GC Saliva-Check BUFFER in Tooth Wear, sponsored by Hacettepe University. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Hacettepe University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Nov 2014, registered Jun 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tooth Wear

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Keywords

  • Tooth wear, risk factors, saliva, diet, oral hygiene
03

In context

Tooth Wear

62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.

This study's enrollment of 100 is above the median of 49 across 41 interventional studies indexed under Tooth Wear.

Browse Tooth Wear studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,009 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject is in good health. Subject is able to understand and read the questionnaire.

Exclusion criteria

Exclusion Criteria:

Wearing orthodontic appliances, Having crowns or partial dentures Using any medications.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    GC Saliva-Check BUFFER

    Saliva test pH Buffering capacity Flow rate

    Diagnostic Test: GC Saliva-Check BUFFER

Interventions

  • Diagnostic testGC Saliva-Check BUFFER

    Evaluating the saliva flow rate, saliva pH and saliva buffering capacity

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

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 23713646 ↗
  • El 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 21654171 ↗
  • Zero 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2014 to primary completion in Jun 2015, 7 months.

Of 21 interventional studies with no phase under Tooth Wear, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 30. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2017
First posted
Jun 23, 2017
StartActual
Nov 28, 2014
Primary completionActual
Jun 30, 2015
CompletionActual
Jan 18, 2016
Last update
Jun 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03197727
Responsible party
Cansu Atalay (Postdoc reseacher, DDS, Ph.D, Hacettepe University) — Principal investigator
First posted
Jun 23, 2017
Start date
Nov 28, 2014
Primary completion
Jun 30, 2015
Completion
Jan 18, 2016
Last update
Jun 23, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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