search
Back to results

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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 22, 2017
    Last Updated
    June 22, 2017
    Sponsor
    Hacettepe University
    search

    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
    background
    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
    background
    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
    background

    Learn more about this trial

    Tooth Wear and Associated Risk Factors

    We'll reach out to this number within 24 hrs