Clinical trial NCT01622920: Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
Official title: Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tooth Erosion
Keywords: enamel erosion
ultrasound
reproducibility
human central incisor
reliability
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Enamel thickness reproducibility measurements
timeFrame: 2 weeks
Secondary outcomes:
measure: Enamel thickness reproducibility measurements on separate occasions
timeFrame: 2 weeks (concurrent with primary outcome)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds, Leeds Dental Institute (DenTCRU)
state: West Yorkshire
Study officials:
affiliation: University of Leeds (Leeds Dental Instiitute)
name: Khalid Sindi, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds (Leeds Dental Institute)
name: Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS
role: STUDY_CHAIR
affiliation: University of Leeds (Leeds Dental Institute)
name: Nigel Bubb, Bsc, PhD
role: STUDY_DIRECTOR
affiliation: University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)
name: Anthony Evans, BSc, MSc, PhD, CSci
role: STUDY_DIRECTOR
References: