Tooth ErosionPhase 1UMETNCT01622920
Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
A Phase 1 study testing Ultrasound transducer in people with Tooth Erosion, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Erosion
- What is being tested?
- Ultrasound transducer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds, Leeds Dental Institute (DenTCRU)
Leeds, West Yorkshire, LS2 9LU
About this study
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.
Read the 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
- Being tested
- Ultrasound transducer
- Keywords
- enamel erosion, ultrasound, reproducibility, human central incisor, reliability
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound transducerOther
A hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded
| Study group | Role | What they receive |
|---|---|---|
| ultrasound enamel thickness measurements | Other | Enamel thickness will be measured with ultrasound Receives: Other: Ultrasound transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel thickness reproducibility measurements
To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo
Measured: 2 weeks
Secondary outcomes (1)
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
Measured: 2 weeks (concurrent with primary outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ErosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Sindi, University of Leeds
- Investigators
- Khalid Sindi, BDS, Principal investigator, University of Leeds (Leeds Dental Instiitute)Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS, Study chair, University of Leeds (Leeds Dental Institute)Nigel Bubb, Bsc, PhD, Study director, University of Leeds (Leeds Dental Institute)Anthony Evans, BSc, MSc, PhD, CSci, Study director, University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622920
- Sponsor's protocol ID
- UMET
- Acronym
- UMET
- Status last verified
- Mar 2013
- First submitted
- 14 Jun 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
- ClinicalTrials.gov ID
- NCT01622920
- Acronym / sponsor ID
- UMET / UMET
- Conditions
- Tooth Erosion
- Keywords
- enamel erosion, ultrasound, reproducibility, human central incisor, reliability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound enamel thickness measurements | Other | Other: Ultrasound transducerEnamel thickness will be measured with ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound transducerA hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded | Other | ultrasound enamel thickness measurements |
Primary outcome
Enamel thickness reproducibility measurements
Time frame: 2 weeks
To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo
1 secondary outcome
Enamel thickness reproducibility measurements on separate occasions
Time frame: 2 weeks (concurrent with primary outcome)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
Related trials for Tooth Erosion
Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Not yet recruitingObservational study
Obesity and Oral Diseases in Adult Patients
Obesity, Oral Diseases
RecruitingObservational study
Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.
Dentin Hypersensitivity, Erosive Tooth Wear
Active, not recruiting
A Study of Tooth Erosion in People With Esophagogastric Cancer
Esophagogastric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid Sindi, BDS principal investigator
University of Leeds (Leeds Dental Instiitute)
Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS study chair
University of Leeds (Leeds Dental Institute)
Nigel Bubb, Bsc, PhD study director
University of Leeds (Leeds Dental Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultrasound transducer in people with Tooth Erosion, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enamel thickness reproducibility measurements (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.