Tooth ErosionNCT02676219
Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth
A study testing RS01 and Water in people with Tooth Erosion, run by Unilever R&D at 1 site in United Kingdom.
Trial 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. 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?
- RS01 and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2015to 18 Sep 2015
- Phase
- Interventional
- 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
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Oral and Dental Science
Bristol, BS1 2LY
About this study
Official title: 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.
- Conditions
- Tooth Erosion
- Being tested
- RS01, Water
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS01Other
Oral Care product containing sodium monofluorophosphate and sodium fluoride
WaterOther
| Study group | Role | What they receive |
|---|---|---|
| RS01 | Experimental | oral care product containing containing sodium monofluorophosphate and sodium fluoride Receives: Other: RS01 |
| Water | Placebo comparator | Water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Measured: 6 hours
Secondary outcomes (1)
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start1 Jul 2015
- Primary completion18 Sep 2015
- Study completion18 Sep 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bristol Dental Hospital
- Responsible party
- Sponsor
- Investigators
- Nicola X West, BDS, Principal investigator, University of Bristol Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676219
- Sponsor's protocol ID
- ORL-IST-2190
- Status last verified
- Jun 2018
- First submitted
- 9 Dec 2015
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02676219
- Acronym / sponsor ID
- ORL-IST-2190
- Conditions
- Tooth Erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- University of Bristol Dental Hospital
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 18 Sep 2015 (actual)
- Study completion
- 18 Sep 2015 (actual)
- First posted
- 8 Feb 2016 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RS01 | Experimental | Other: RS01oral care product containing containing sodium monofluorophosphate and sodium fluoride |
| Water | Placebo comparator | Other: WaterWater |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (22 listed)
- 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
- General Dental Exclusions
- Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
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 |
|---|---|---|
| RS01Oral Care product containing sodium monofluorophosphate and sodium fluoride | Other | RS01 |
| Water | Other | Water |
Primary outcome
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Time frame: 6 hours
1 secondary outcome
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Time frame: 2 hours
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 8 Jun 2018.
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.
Nicola X West, BDS principal investigator
University of Bristol Dental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS01 and Water in people with Tooth Erosion, run by Unilever R&D 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 7 inclusion and 22 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 8 Jun 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
changes in enamel surface topography using an impression methodology with scanning electron microscopy (time frame: 6 hours). 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 8 Jun 2018.