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
About this trial
This is an interventional other trial for Tooth Wear
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.
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
NCT ID
NCT03178968
First Posted
May 30, 2017
Last Updated
June 5, 2017
Sponsor
King's College London
Collaborators
GlaxoSmithKline
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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Can Surface Roughness Predict Progression of Tooth Wear?
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