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CompletedNCT01622920UMETUpdated Mar 19, 2013

Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

A Phase 1 interventional study of Ultrasound transducer in Tooth Erosion, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-19.

Sponsored by University of Leeds · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Erosion

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Keywords

  • enamel erosion
  • ultrasound
  • reproducibility
  • human central incisor
  • reliability
03

In context

Tooth Erosion

47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.

This study's enrollment of 30 is close to the median of 33 across 33 interventional studies indexed under Tooth Erosion.

Browse Tooth Erosion studies →

Lead sponsor

University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  5. Volunteers who are willing to follow the research schedule for the period of the study.

Exclusion criteria

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 not obtained by the volunteer.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    ultrasound enamel thickness measurements

    Enamel thickness will be measured with ultrasound

    Other: Ultrasound transducer

Interventions

  • OtherUltrasound transducer

    A hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded

06

What researchers measure

Primary outcomes

  1. Enamel thickness reproducibility measurements

    To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo

    Time frame: 2 weeks

Secondary outcomes

  1. 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

    Time frame: 2 weeks (concurrent with primary outcome)

07

Study locations

1 site
  • University of Leeds, Leeds Dental Institute (DenTCRU)
    Leeds, West Yorkshire LS2 9LU, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2012
First posted
Jun 19, 2012
Start
Nov 2012
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
Mar 19, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01622920
Lead sponsor
University of Leeds
Responsible party
Khalid Sindi (Mr, University of Leeds) — Principal investigator
First posted
Jun 19, 2012
Start date
Nov 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Mar 19, 2013

Study contacts

Khalid Sindi, BDS
principal investigator · University of Leeds (Leeds Dental Instiitute)
Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS
study chair · University of Leeds (Leeds Dental Institute)
Nigel Bubb, Bsc, PhD
study director · University of Leeds (Leeds Dental Institute)
Anthony Evans, BSc, MSc, PhD, CSci
study director · University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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