Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth (NCT02676219) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth
United Kingdom16 participantsStarted 2015-07-01
Plain-language summary
The study design is a randomised, split mouth, blind with respect to study analysts (microscopist, image grader) two treatment clinical study in 10 healthy participants with sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5 subsequent clinic visits. At the screening visit, participants will give consent to participate in the study. Medical history and concomitant medications will be recorded. Eligibility will be determined following an oral soft tissue (OST) examination and an evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will be collected from the participants at set points during the study to look at any changes in salivary pH.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
✓. Age: Aged at least 18 years.
✓. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
✓. General Health: Good general health with (in the opinion of the investigator or medically qualified designee) no clinically significant and relevant abnormalities of medical history or physical examination.
✓. Diagnosis:
✓. Study teeth must show no signs of exposed dentine at the cervical margin.
✓. In the opinion of the investigator the study teeth must have a healthy gingiva as determined during the OST examination.
Exclusion criteria
✕. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
What they're measuring
1
changes in enamel surface topography using an impression methodology with scanning electron microscopy