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Can Surface Roughness Predict Progression of Tooth Wear?

Primary Purpose

Tooth Wear

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orange juice
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tooth Wear

Eligibility Criteria

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

Inclusion Criteria:

  • mild erosive tooth wear maximum score of 2 in each sextant and cumulative score no more than 8, aged 18 years and over, willing to participate, not enrolled in any other research, more than 20 anterior and posterior teeth, no active carious lesions and a maximum BPE score of 2 in one sextant (no periodontal disease).

Exclusion Criteria:

  • pregnancy or breast feeding, medical history likely to impact on attendance or mobility, insulin dependent diabetes, saliva diagnoses (xerostomia), lower orthodontic appliances, dentine hypersensitivity, defective restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars and any condition that precluded consumption of 300 ml of orange juice a day for 5 consecutive days.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    15 minutes' erosion

    30 minutes' erosion

    45 minutes' erosion

    Arm Description

    Orange juice is administered ex vivo and in vivo for 5 minutes and repeated a total of 3 times

    Orange juice is administered ex vivo and in vivo for 10 minutes and repeated a total of 3 times

    Orange juice is administered ex vivo and in vivo for 15 minutes and repeated a total of 3 times

    Outcomes

    Primary Outcome Measures

    Microhardness (KHN)
    To measure microhardness of enamel samples using a microhardness tester before and after the intervention. The units will be KHN

    Secondary Outcome Measures

    Surface roughness
    To measure surface roughness of enamel samples using anon contact profilometer before and after the intervention. The units will be microns.
    Step height loss
    To measure step height loss of enamel samples following the intervention using a non contact profilometer. The units will be microns.

    Full Information

    First Posted
    May 30, 2017
    Last Updated
    June 5, 2017
    Sponsor
    King's College London
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03178968
    Brief Title
    Can Surface Roughness Predict Progression of Tooth Wear?
    Official Title
    Can Surface Roughness Predict Progression of Tooth Wear in Participants With Dietary Origins of Acid?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2017 (Actual)
    Primary Completion Date
    May 29, 2017 (Actual)
    Study Completion Date
    May 29, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The clinical study was a single-blind, randomised intervention study to measure surface changes of polished and unpolished enamel in situ following an orange juice acid challenge. Ethical approval for the study was granted by the Stanmore Health Research Authority REC ref 15/LO/0417, and the study was conducted per the guidelines for Good Clinical Practice. The study investigated a total 6 erosion regimes divided in 3 different erosion times plus ex vivo immersion in orange juice drink versus in vivo rinsing of the same orange juice drink.
    Detailed Description
    60 unpolished and 60 polished enamel samples were prepared from extracted human molars collected under ethical approval. 30 healthy volunteers were recruited and lower dental impressions were recorded using standard stock trays. Custom made lower orthoodontic type appliances were made by the laboratory to accommodate a total of four enamel (2 left and right hand side) samples positioned buccally in the premolar/molar region. The volunteers were randomly allocated into one of 3 groups: 5 mins erosion repeated x3, 10 mins erosion repeated x3 or 15 mins erosion repeated x3 and a coin was flipped to determine which side the samples were to be removed for ex vivo immersion with tails for left and heads for right. . At the beginning of the study visit the splints were inserted and worn for 30 minutes. Following which the enamel samples (1 polished and 1 unpolished) were removed from one side to begin the erosion regime. For in vivo erosion each participant was asked to rinse with orange juice for their either time 5, 10 or 15 minutes. This was standardised by setting up cups with 10 mL of the orange juice and a timer set at 1 minute. The participant was asked to insert the liquid into their mouths start the time and when the alarm sounded expectorate and repeat until they completed his/her time allocation of either 5, 10 or 15 minutes. Simultaneously the ex vivo samples were immersed in 20 mL of orange juice and agitated at 62 rpm for the allocated time using an orbital shaker (Stuart Scientific, Mini Orbital Shaker S05, Bibby). This completed one cycle after which the removed samples were reinserted into the splint which was worn for a further hour after which the rinsing/immersion regime was repeated. The process was repeated a further instance to complete 3 cycles of erosion. After the 3rd and final erosion cycle the participants were given a desensitising toothpaste Sensodyne Repair & Protect (GSK, Weybridge, UK). The unpolished enamel samples were analysed before and after the experiment to measure changes in surface texture. Whereas, the polished samples were analysed for surface texture, hardness change and tissue loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Wear

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    single-blind, randomised intervention study (blinded for the surface roughness measurements, step height measurements and microhardness testing)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    15 minutes' erosion
    Arm Type
    Experimental
    Arm Description
    Orange juice is administered ex vivo and in vivo for 5 minutes and repeated a total of 3 times
    Arm Title
    30 minutes' erosion
    Arm Type
    Experimental
    Arm Description
    Orange juice is administered ex vivo and in vivo for 10 minutes and repeated a total of 3 times
    Arm Title
    45 minutes' erosion
    Arm Type
    Experimental
    Arm Description
    Orange juice is administered ex vivo and in vivo for 15 minutes and repeated a total of 3 times
    Intervention Type
    Other
    Intervention Name(s)
    Orange juice
    Intervention Description
    3 immersion times in orange juice were investigated
    Primary Outcome Measure Information:
    Title
    Microhardness (KHN)
    Description
    To measure microhardness of enamel samples using a microhardness tester before and after the intervention. The units will be KHN
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Surface roughness
    Description
    To measure surface roughness of enamel samples using anon contact profilometer before and after the intervention. The units will be microns.
    Time Frame
    12 weeks
    Title
    Step height loss
    Description
    To measure step height loss of enamel samples following the intervention using a non contact profilometer. The units will be microns.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: mild erosive tooth wear maximum score of 2 in each sextant and cumulative score no more than 8, aged 18 years and over, willing to participate, not enrolled in any other research, more than 20 anterior and posterior teeth, no active carious lesions and a maximum BPE score of 2 in one sextant (no periodontal disease). Exclusion Criteria: pregnancy or breast feeding, medical history likely to impact on attendance or mobility, insulin dependent diabetes, saliva diagnoses (xerostomia), lower orthodontic appliances, dentine hypersensitivity, defective restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars and any condition that precluded consumption of 300 ml of orange juice a day for 5 consecutive days.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29339202
    Citation
    Mullan F, Austin RS, Parkinson CR, Bartlett DW. An in-situ pilot study to investigate the native clinical resistance of enamel to erosion. J Dent. 2018 Mar;70:124-128. doi: 10.1016/j.jdent.2018.01.005. Epub 2018 Jan 12.
    Results Reference
    derived

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