Tooth Wear and Associated Risk Factors
Primary Purpose
Tooth Wear
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GC Saliva-Check BUFFER
Sponsored by
About this trial
This is an interventional diagnostic trial for Tooth Wear focused on measuring Tooth wear, risk factors, saliva, diet, oral hygiene
Eligibility Criteria
Inclusion Criteria:
Subject is in good health. Subject is able to understand and read the questionnaire.
Exclusion Criteria:
Wearing orthodontic appliances, Having crowns or partial dentures Using any medications.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GC Saliva-Check BUFFER
Arm Description
Saliva test pH Buffering capacity Flow rate
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03197727
Brief Title
Tooth Wear and Associated Risk Factors
Official Title
Evaluation of Tooth Wear and Associated Risk Factors: a Matched Case-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 28, 2014 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
January 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Wear
Keywords
Tooth wear, risk factors, saliva, diet, oral hygiene
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GC Saliva-Check BUFFER
Arm Type
Other
Arm Description
Saliva test pH Buffering capacity Flow rate
Intervention Type
Diagnostic Test
Intervention Name(s)
GC Saliva-Check BUFFER
Intervention Description
Evaluating the saliva flow rate, saliva pH and saliva buffering capacity
Primary Outcome Measure Information:
Title
Saliva test
Description
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 Outcome Measure Information:
Title
Tooth wear
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is in good health. Subject is able to understand and read the questionnaire.
Exclusion Criteria:
Wearing orthodontic appliances, Having crowns or partial dentures Using any medications.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23713646
Citation
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.
Results Reference
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PubMed Identifier
21654171
Citation
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.
Results Reference
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PubMed Identifier
16167607
Citation
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.
Results Reference
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Tooth Wear and Associated Risk Factors
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