Gingival DiseasesNCT03027908
A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
A study testing Fluoride Toothpaste 1 and Fluoride Toothpaste 2 in people with Gingival Diseases, run by Unilever R&D.
Trial summary
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged over 18 years will participate. The participants will be randomised into two groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Fluoride Toothpaste 1 and Fluoride Toothpaste 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2016to 8 May 2017
- 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
- Be willing and physically able to carry out all study procedures.
- Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form.
- Have at least 20 natural teeth including 5 teeth (excluding 3rd molars) in each quadrant
- Have a mean Modified Gingival Index (MGI) score of between 2.00 and 2.75 at screening.
- Not have had a scale and prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study.
- Be willing to use only the test products for 6 months
Who cannot join
- Current participation in any other cosmetic trials, any dental clinical trials or clinical trials.
- Pregnant or breast feeding mothers.
- Medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs
- Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will affect either the scientific validity of the study or if the participant was to participate in the study would affect their wellbeing.
- Any participant who, in the judgement of the investigator, should not participate in the study.
- Full or partial dentures wearers.
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- Current orthodontic treatment.
- Have oral piercings.
- Smokers or those who have a recent smoking history, including e-cigarettes.
- Taking dietary supplements (e.g. multivitamins; antioxidants; fish oils).
- Any subject with a single MGI score of 4 in the any area of the mouth at any time point will be excluded.
- A subject will be excluded from the study if they have a MGI mouth mean of greater than 2.75 at screening
- Any subject with a single MGI score of 3 at Baseline
- Use of non study oral care products, e.g. dental floss, chewing gum, mouth rinses during the pre treatment and test phases of the study.
- The subject is an employee of Unilever or a member of the study team.
- Taking a course of antimicrobial or anti-inflammatory drugs within 4 weeks of screening
- Those taking anti-histamine or anti-inflammatory medication in the 24 hours prior to the dental assessments
- Diabetics
- Vegetarians and Vegans
About this study
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged over 18 years will participate. The participants will be randomised into two groups. Participants will be randomly assigned to the test groups according the allocation table prepared by the Statistician.
Participants will be enrolled on to the study according to the inclusion/exclusion criteria. After enrollment participants will have their teeth cleaned using a professional prophylaxis polish by the study hygienist. The participants will then be provided with a standard cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to four weeks. After this time, they will return to the test site and have the baseline dental assessments. Participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments will be conducted after 13 and 26 weeks of product use at the study site.
- Conditions
- Gingival Diseases
- Being tested
- Fluoride Toothpaste 1, Fluoride Toothpaste 2
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride Toothpaste 1Other
Also called A1
Toothpaste containing 1450 ppm F as Sodium Fluoride
Fluoride Toothpaste 2Other
Also called A2
Toothpaste containing 1450 ppm F as Sodium Fluoride
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Toothpaste 1 | Experimental | Toothpaste containing Sodium Fluoride at 1450 ppm F Receives: Other: Fluoride Toothpaste 1 |
| Fluoride Toothpaste 2 | Active comparator | Toothpaste containing Sodium Fluoride at 1450 ppm F Receives: Other: Fluoride Toothpaste 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival condition as measured by the Modified Lobene Gingival Index
Measured: 13 weeks
Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Measured: 13 weeks
Change in plaque levels as measure by the Quigley and Hein Plaque index
Measured: 13 weeks
Secondary outcomes (3)
change in gingival condition as measured by the Modified Lobene Gingival Index
Measured: 26 weeks
change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Measured: 26 weeks
Change in plaque levels as measured by the Quigley and Hein plaque index
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start19 Oct 2016
- Primary completion8 May 2017
- Study completion8 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola X West, Professor, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027908
- Sponsor's protocol ID
- ORL-GUM-2544
- Status last verified
- Jun 2018
- First submitted
- 9 Dec 2016
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
- ClinicalTrials.gov ID
- NCT03027908
- Acronym / sponsor ID
- ORL-GUM-2544
- Conditions
- Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 8 May 2017 (actual)
- First posted
- 23 Jan 2017 (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.
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged over 18 years will participate. The participants will be randomised into two groups. Participants will be randomly assigned to the test groups according the allocation table prepared by the Statistician.
Participants will be enrolled on to the study according to the inclusion/exclusion criteria. After enrollment participants will have their teeth cleaned using a professional prophylaxis polish by the study hygienist. The participants will then be provided with a standard cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to four weeks. After this time, they will return to the test site and have the baseline dental assessments. Participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments will be conducted after 13 and 26 weeks of product use at the study site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride Toothpaste 1 | Experimental | Other: Fluoride Toothpaste 1Toothpaste containing Sodium Fluoride at 1450 ppm F |
| Fluoride Toothpaste 2 | Active comparator | Other: Fluoride Toothpaste 2Toothpaste containing Sodium Fluoride at 1450 ppm F |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be willing and physically able to carry out all study procedures.
- Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form.
- Have at least 20 natural teeth including 5 teeth (excluding 3rd molars) in each quadrant
- Have a mean Modified Gingival Index (MGI) score of between 2.00 and 2.75 at screening.
- Not have had a scale and prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study.
Key exclusion criteria (19 listed)
- Current participation in any other cosmetic trials, any dental clinical trials or clinical trials.
- Pregnant or breast feeding mothers.
- Medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs
- Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will affect either the scientific validity of the study or if the participant was to participate in the study would affect their wellbeing.
- Any participant who, in the judgement of the investigator, should not participate in the study.
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 |
|---|---|---|
| Fluoride Toothpaste 1Also: A1Toothpaste containing 1450 ppm F as Sodium Fluoride | Other | Fluoride Toothpaste 1 |
| Fluoride Toothpaste 2Also: A2Toothpaste containing 1450 ppm F as Sodium Fluoride | Other | Fluoride Toothpaste 2 |
Primary outcome
Change in gingival condition as measured by the Modified Lobene Gingival Index
Time frame: 13 weeks
Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Time frame: 13 weeks
Change in plaque levels as measure by the Quigley and Hein Plaque index
Time frame: 13 weeks
3 secondary outcomes
change in gingival condition as measured by the Modified Lobene Gingival Index
Time frame: 26 weeks
change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Time frame: 26 weeks
Change in plaque levels as measured by the Quigley and Hein plaque index
Time frame: 26 weeks
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 7 Jun 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.
Nicola X West, Professor principal investigator
University of Bristol
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride Toothpaste 1 and Fluoride Toothpaste 2 in people with Gingival Diseases, run by Unilever R&D.
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 6 inclusion and 19 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in gingival condition as measured by the Modified Lobene Gingival Index (time frame: 13 weeks). The study lists 3 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 7 Jun 2018.