Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

Tooth Erosion Clinical Trial

— UMET  

Official title:

Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622920
• Other study ID #: UMET
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2012
• Last updated: March 15, 2013
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tooth Erosion

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Leeds, Leeds Dental Institute (DenTCRU)	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enamel thickness reproducibility measurements	To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo	2 weeks	No
Secondary	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)	No