Back to resultsPreliminary Clinical Study of Ultrasound to Measure Enamel Thickness (UMET)
Primary Purpose
Tooth Erosion
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound transducer
Sponsored by
About this trial
This is an interventional diagnostic trial for Tooth Erosion focused on measuring enamel erosion, ultrasound, reproducibility, human central incisor, reliability
Eligibility Criteria
Inclusion Criteria:
- Healthy adults over 18 years (females and males) with normal salivary flow.
- Volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study.
- Volunteers should have sound maxillary incisors with no obvious cracks in the crown.
- Volunteers who willingly signed an informed consent.
- Volunteers who are willing to follow the research schedule for the period of the study.
Exclusion Criteria:
- Volunteers with abnormal enamel on maxillary incisors assessed by visual inspection.
- Volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges).
- Volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect.
- Volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth).
- Volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction.
- Volunteers who have any condition could be expected to interfere with the volunteer's safety during the study.
- Volunteers who demonstrate an inability to comply with study procedures.
- Signed informed consent not obtained by the volunteer.
Sites / Locations
- University of Leeds, Leeds Dental Institute (DenTCRU)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ultrasound enamel thickness measurements
Arm Description
Enamel thickness will be measured with ultrasound
Outcomes
Primary Outcome Measures
Enamel thickness reproducibility measurements
To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo
Secondary Outcome Measures
Enamel thickness reproducibility measurements on separate occasions
To investigate whether ultrasound can be used to reproducibly measure enamel thickness on human incisor teeth in vivo on three separate occasions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01622920
Brief Title
Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
Acronym
UMET
Official Title
Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators have now established a technique to measure enamel thickness which has been shown to work well in-vitro. The teeth tested so far, obtained from the Dental School Tissue Bank, have been molars or pre-molars. In these cases, the measurement is made more difficult by the curvature of the tooth surface and it seems likely that flatter larger, incisors would give more satisfactory results. The investigators therefore wish to establish in-vivo whether this hypothesis is correct.
Detailed Description
The aim is translate our research into a clinical hand-held dental tool that could be used to measure enamel thickness in less curvaceous anterior incisor (front) teeth, and ultimately monitor erosive tooth surface loss (TSL), which mainly occurs on anterior (front) teeth and the occlusal (top) surface of posterior (back) teeth. In this study, quantifying enamel thickness with ultrasound will provide data which will be assessed for reproducibility and to determine whether or not ultrasound is a potentially viable tool to measure and monitor acid erosion of teeth. This would allow dentists to reinforce advice to patients to reduce acidic consumption, and will motivate them to keep whatever is remaining of their 'precious' enamel tissue, which if lost, will necessitate fillings to be made. These fillings will require future repairs and possible remakes, as they have median survival rates of five years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Erosion
Keywords
enamel erosion, ultrasound, reproducibility, human central incisor, reliability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound enamel thickness measurements
Arm Type
Other
Arm Description
Enamel thickness will be measured with ultrasound
Intervention Type
Other
Intervention Name(s)
Ultrasound transducer
Intervention Description
A hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded
Primary Outcome Measure Information:
Title
Enamel thickness reproducibility measurements
Description
To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Enamel thickness reproducibility measurements on separate occasions
Description
To investigate whether ultrasound can be used to reproducibly measure enamel thickness on human incisor teeth in vivo on three separate occasions
Time Frame
2 weeks (concurrent with primary outcome)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults over 18 years (females and males) with normal salivary flow.
Volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study.
Volunteers should have sound maxillary incisors with no obvious cracks in the crown.
Volunteers who willingly signed an informed consent.
Volunteers who are willing to follow the research schedule for the period of the study.
Exclusion Criteria:
Volunteers with abnormal enamel on maxillary incisors assessed by visual inspection.
Volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges).
Volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect.
Volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth).
Volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction.
Volunteers who have any condition could be expected to interfere with the volunteer's safety during the study.
Volunteers who demonstrate an inability to comply with study procedures.
Signed informed consent not obtained by the volunteer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Sindi, BDS
Organizational Affiliation
University of Leeds (Leeds Dental Instiitute)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS
Organizational Affiliation
University of Leeds (Leeds Dental Institute)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nigel Bubb, Bsc, PhD
Organizational Affiliation
University of Leeds (Leeds Dental Institute)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anthony Evans, BSc, MSc, PhD, CSci
Organizational Affiliation
University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)
Official's Role
Study Director
Facility Information:
Facility Name
University of Leeds, Leeds Dental Institute (DenTCRU)
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9LU
Country
United Kingdom
12. IPD Sharing Statement
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Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
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