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Completed

NCT Number: NCT01622920

Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Leeds, Leeds Dental Institute (DenTCRU)

Leeds, West Yorkshire, LS2 9LU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound transducer

Other

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

Primary outcomes

  1. Enamel thickness reproducibility measurements

    Time frame: 2 weeks

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Acronym: UMET

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2012
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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