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Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness (UMET)

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ClinicalTrials.gov Identifier: NCT01622920
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Khalid Sindi, University of Leeds

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.

Condition or disease Intervention/treatment Phase
Tooth Erosion Other: Ultrasound transducer Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
Study Start Date : November 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
ultrasound enamel thickness measurements
Enamel thickness will be measured with ultrasound
Other: Ultrasound transducer
A hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded




Primary Outcome Measures :
  1. Enamel thickness reproducibility measurements [ Time Frame: 2 weeks ]
    To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo


Secondary Outcome Measures :
  1. Enamel thickness reproducibility measurements on separate occasions [ Time Frame: 2 weeks (concurrent with primary outcome) ]
    To investigate whether ultrasound can be used to reproducibly measure enamel thickness on human incisor teeth in vivo on three separate occasions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults over 18 years (females and males) with normal salivary flow.
  2. Volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study.
  3. Volunteers should have sound maxillary incisors with no obvious cracks in the crown.
  4. Volunteers who willingly signed an informed consent.
  5. Volunteers who are willing to follow the research schedule for the period of the study.

Exclusion Criteria:

  1. Volunteers with abnormal enamel on maxillary incisors assessed by visual inspection.
  2. Volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges).
  3. Volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect.
  4. Volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth).
  5. Volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction.
  6. Volunteers who have any condition could be expected to interfere with the volunteer's safety during the study.
  7. Volunteers who demonstrate an inability to comply with study procedures.
  8. Signed informed consent not obtained by the volunteer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622920


Locations
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United Kingdom
University of Leeds, Leeds Dental Institute (DenTCRU)
Leeds, West Yorkshire, United Kingdom, LS2 9LU
Sponsors and Collaborators
University of Leeds
Investigators
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Principal Investigator: Khalid Sindi, BDS University of Leeds (Leeds Dental Instiitute)
Study Chair: Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS University of Leeds (Leeds Dental Institute)
Study Director: Nigel Bubb, Bsc, PhD University of Leeds (Leeds Dental Institute)
Study Director: Anthony Evans, BSc, MSc, PhD, CSci University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)
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Responsible Party: Khalid Sindi, Mr, University of Leeds
ClinicalTrials.gov Identifier: NCT01622920    
Other Study ID Numbers: UMET
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013
Keywords provided by Khalid Sindi, University of Leeds:
enamel erosion
ultrasound
reproducibility
human central incisor
reliability
Additional relevant MeSH terms:
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Tooth Erosion
Tooth Wear
Tooth Diseases
Stomatognathic Diseases