Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

NCT ID: NCT01622920

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Tooth Erosion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultrasound enamel thickness measurements

Enamel thickness will be measured with ultrasound

Group Type: OTHER

Ultrasound transducer

Intervention Type: OTHER

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

Interventions

Ultrasound transducer

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Khalid Sindi

Mr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khalid Sindi, BDS

Role: PRINCIPAL_INVESTIGATOR

University of Leeds (Leeds Dental Instiitute)

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

Role: STUDY_CHAIR

University of Leeds (Leeds Dental Institute)

Nigel Bubb, Bsc, PhD

Role: STUDY_DIRECTOR

University of Leeds (Leeds Dental Institute)

Anthony Evans, BSc, MSc, PhD, CSci

Role: STUDY_DIRECTOR

University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)

Locations

University of Leeds, Leeds Dental Institute (DenTCRU)

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

UMET

Identifier Type: -

Identifier Source: org_study_id