Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

NCT01622920 | Completed Phase 1

• 1 other identifier: UMET
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Erosion

Keywords

enamel erosion; ultrasound; reproducibility; human central incisor; reliability

Outcome Measures

Primary Outcomes (1)

• Enamel thickness reproducibility measurements

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

  2 weeks

Secondary Outcomes (1)

• Enamel thickness reproducibility measurements on separate occasions

  2 weeks (concurrent with primary outcome)

Study Arms (1)

ultrasound enamel thickness measurements

OTHER

Enamel thickness will be measured with ultrasound

Other: Ultrasound transducer

Interventions

Ultrasound transducer OTHER

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

ultrasound enamel thickness measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

University of Leeds, Leeds Dental Institute (DenTCRU)

Leeds, West Yorkshire, LS2 9LU, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Khalid Sindi, BDS

  University of Leeds (Leeds Dental Instiitute)

  PRINCIPAL INVESTIGATOR

• Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS

  University of Leeds (Leeds Dental Institute)

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 19, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

GB (1)