- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676219
Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth
June 6, 2018 updated by: Unilever R&D
Pilot Study to Investigate the Reparative Effect of a Two Phase Oral Care Product Containing SMFP and NaF on Enamel Against a Dietary Acid Exposure Utilising an Impression Technique to Capture in Vivo Images of Teeth
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bristol, United Kingdom, BS1 2LY
- School of Oral and Dental Science
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
- Breast-feeding Women who are breast-feeding.
Disease
- Current or recurrent disease/dental pathology that could affect the assessments.
- In the judgement of the investigator or medically qualified designee, any condition or medication which is causing cause Xerostomia.
- Diabetes Mellitus.
- Susceptibility to acid regurgitation.
- Be susceptible to high dental erosion after drinking acidic soft drinks or juices
General Dental Exclusions
- Any orthodontic appliances, restorations, bridgework or dentures that would interfere with the study evaluations or scheduled for such treatment within the timescale of the study.
- Recurrent or regular aphthous ulcers.
- Severe gingivitis, carious lesions treated and untreated periodontal disease.
- Excessive signs of dental erosion or a previous history of being susceptible to high dental erosion after drinking acidic drinks
- Tooth bleaching within past 2 months.
- Suffer from dentine hypersensitivity.
- Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous randomisation into this study.
- Substance abuse Recent history (within the last year) of alcohol or other substance abuse.
- Personnel An employee of the sponsor, member of the study site or a staff family relative. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate.
- Any participant who, in the judgement of the investigator, should not participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Water
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Experimental: RS01
oral care product containing containing sodium monofluorophosphate and sodium fluoride
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Oral Care product containing sodium monofluorophosphate and sodium fluoride
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Time Frame: 6 hours
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicola X West, BDS, University of Bristol Dental Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
September 18, 2015
Study Completion (Actual)
September 18, 2015
Study Registration Dates
First Submitted
December 9, 2015
First Submitted That Met QC Criteria
February 3, 2016
First Posted (Estimate)
February 8, 2016
Study Record Updates
Last Update Posted (Actual)
June 8, 2018
Last Update Submitted That Met QC Criteria
June 6, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORL-IST-2190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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