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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Erosion
• Intervention / Treatment: Other: Ultrasound transducer

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enamel thickness reproducibility measurements	To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks (concurrent with primary outcome)

Collaborators and Investigators

• Sponsor: University of Leeds
• Investigators: 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)

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: ultrasound; reliability; reproducibility; enamel erosion; human central incisor
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion
• Other Study ID Numbers: UMET