Sloughing SkinNCT03598881
A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
A study testing Treatment in people with Sloughing Skin and Mucosal Inflammation, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste.. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sloughing Skin, Mucosal Inflammation
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2016to 21 Nov 2016
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Internal (University of Birmingham Dental School) panellists only
- Willing to sign an informed consent form and complete a medical history questionnaire.
- Must be available for the duration of the study.
- Must be a current non-smoker and not chew tobacco.
- Have a minimum of 8 teeth in both upper and lower jaws, which are free from obvious untreated caries or significant periodontal disease
Who cannot join
- Show unwillingness, inability or lack of motivation to carry out the study procedures
- Are pregnant or breastfeeding females.
- Are diabetic.
- Have severe oral mucosal problems.
- Orthodontic banding or removable partial dentures
- Have an active cold sore.
Show all 17Show fewer
- Have any oral piercings.
- Have a mouth ulcer or who experience mouth ulcers on a regular basis, Lichen Planus Vesiculo-Bullous disorders
- Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will effect either the scientific validity of the study or if the volunteer's participation would affect their well being
- Volunteers who are at risk from transient bacteraemias.
- Regular use of medication, which could interfere with study objectives or affect the validity of the study.
- Have or have had a medical or dental condition, which in the option of the dentist would make them unsuitable for inclusion.
- Have problem of bleeding after brushing.
- Must not be a regular user of chlorhexidine mouthwash, or have used it within the past 6 weeks.
- Has allergic responses to dental/oral hygiene products or components in the formulation of the toothpaste.
- The subject is participating in other studies testing oral care products.
- The subject is an employee of Unilever.
Trial locations and contacts
1 site in 1 country.
About this study
This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..
Read the detailed description
Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. Clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. Supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth.
For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale.
The following outcomes will be generated from the sloughing data:
- Whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12;
- Subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.
- Conditions
- Sloughing Skin, Mucosal Inflammation
- Being tested
- Treatment
- Medical subject headings
- Necrosis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS) Receives: Other: Treatment |
| Comparator | Active comparator | Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS) Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate number of lesions
Total lesion count aggregated across all subjects
Measured: 30 minutes
Aggregate number of lesions
Total lesion count aggregated across all subjects
Measured: 4 days
Secondary outcomes (2)
Lesion severity
Subject level mucosal severity sloughing score
Measured: 30 minutes
Lesion severity
Subject level mucosal severity sloughing score
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start19 Sep 2016
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sloughing SkinStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Iain Chapple, Professor, Principal investigator, The University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598881
- Sponsor's protocol ID
- ORL-OSS-2545
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
- ClinicalTrials.gov ID
- NCT03598881
- Acronym / sponsor ID
- ORL-OSS-2545
- Conditions
- Sloughing Skin, Mucosal Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- University of Birmingham
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..
Detailed description
Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. Clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. Supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth.
For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale.
The following outcomes will be generated from the sloughing data:
- Whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12;
- Subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: TreatmentToothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS) |
| Comparator | Active comparator | Other: TreatmentToothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Internal (University of Birmingham Dental School) panellists only
- Willing to sign an informed consent form and complete a medical history questionnaire.
- Must be available for the duration of the study.
- Must be a current non-smoker and not chew tobacco.
- Have a minimum of 8 teeth in both upper and lower jaws, which are free from obvious untreated caries or significant periodontal disease
Key exclusion criteria (17 listed)
- Show unwillingness, inability or lack of motivation to carry out the study procedures
- Are pregnant or breastfeeding females.
- Are diabetic.
- Have severe oral mucosal problems.
- Orthodontic banding or removable partial dentures
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 |
|---|---|---|
| Treatment | Other | Comparator, Treatment |
Primary outcome
Aggregate number of lesions
Time frame: 30 minutes
Total lesion count aggregated across all subjects
Aggregate number of lesions
Time frame: 4 days
Total lesion count aggregated across all subjects
2 secondary outcomes
Lesion severity
Time frame: 30 minutes
Lesion severity
Time frame: 4 days
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 26 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Iain Chapple, Professor principal investigator
The University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Sloughing Skin and Mucosal Inflammation, 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 5 inclusion and 17 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 26 Jul 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. 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?
Aggregate number of lesions (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 26 Jul 2018.