HealthyNCT02676440
Effect of a Toothpaste and Serum Compared to Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.
A study testing Treatment and Comparator in people with Healthy, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy female and male participants aged over 18 years will participate. There will be two groups of up to 120 participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment and Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2015to 14 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged 18 years and over, of either gender and in good health.
- 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 at least 6 natural teeth assessable teeth in the Upper 4 to 4 region.
- Have a mean Modified Gingival Index (MGI) score of 2 at screening in the Upper 4 to 4 region.
- 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 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 nursing women.
- 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 participants 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.
Show all 18Show fewer
- Current orthodontic treatment.
- Have oral piercings.
- Smokers or those who have a recent smoking history.
- 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 >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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bristol Dental Hospital and School
Bristol, BS1 2LY
About this study
Official title: A Study to Measure the Effect of a Toothpaste Containing Zinc Citrate Trihydrate Used in Combination With a Serum Containing Zinc Sulphate Heptahydrate and a Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.
This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy female and male participants aged over 18 years will participate. There will be two groups of up to 120 participants. Participants will be randomised 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 that have been allocated for assessment cleaned using a professional prophylaxis polish by the study dentist. 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
- Healthy
- Being tested
- Treatment, Comparator
- Keywords
- Oral Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
F13/T38
ComparatorOther
M26
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Toothpaste containing 1.11% Fluoride as Sodium Monofluorophosphate and Zinc Citrate Trihydrate Serum containing 0.17% Fluoride as Sodium Monofluorophosphate and Zinc Sulphate Heptahydrate Receives: Other: Treatment |
| Comparator | Other | Silica toothpaste 1350ppm F as Sodium Fluoride Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival condition as assessed using the Modified Lobene Gingival Index
Measured: 13 weeks
Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index
Measured: 13 weeks
Change in gingival condition as assessed using the Modified Quigley and Hein plaque index
Measured: 13 weeks
Secondary outcomes (3)
Change in gingival condition as assessed using the Modified Lobene Gingival Index
Measured: 26 weeks
Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index
Measured: 26 weeks
Change in gingival condition as assessed using the Modified 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 posted8 Feb 2016 (estimated)
- Study start3 Jul 2015
- Primary completion14 Dec 2015
- Study completion14 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 222 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, Bristol Dental Hospital and School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676440
- Sponsor's protocol ID
- ORL-GUM-2101
- Status last verified
- Jun 2018
- First submitted
- 3 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
- A Study to Measure the Effect of a Toothpaste Containing Zinc Citrate Trihydrate Used in Combination With a Serum Containing Zinc Sulphate Heptahydrate and a Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.
- ClinicalTrials.gov ID
- NCT02676440
- Acronym / sponsor ID
- ORL-GUM-2101
- Conditions
- Healthy
- Keywords
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- University of Bristol Dental Hospital
- Study start
- 3 Jul 2015 (actual)
- Primary completion
- 14 Dec 2015 (actual)
- Study completion
- 14 Mar 2016 (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.
This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy female and male participants aged over 18 years will participate. There will be two groups of up to 120 participants. Participants will be randomised 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 that have been allocated for assessment cleaned using a professional prophylaxis polish by the study dentist. 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Other: TreatmentToothpaste containing 1.11% Fluoride as Sodium Monofluorophosphate and Zinc Citrate Trihydrate Serum containing 0.17% Fluoride as Sodium Monofluorophosphate and Zinc Sulphate Heptahydrate |
| Comparator | Other | Other: ComparatorSilica toothpaste 1350ppm F as Sodium Fluoride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be aged 18 years and over, of either gender and in good health.
- 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 at least 6 natural teeth assessable teeth in the Upper 4 to 4 region.
Key exclusion criteria (18 listed)
- Current participation in any other cosmetic trials, any dental clinical trials or clinical trials.
- Pregnant or nursing women.
- 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 participants 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 |
|---|---|---|
| TreatmentF13/T38 | Other | Treatment |
| ComparatorM26 | Other | Comparator |
Primary outcome
Change in gingival condition as assessed using the Modified Lobene Gingival Index
Time frame: 13 weeks
Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index
Time frame: 13 weeks
Change in gingival condition as assessed using the Modified Quigley and Hein plaque index
Time frame: 13 weeks
3 secondary outcomes
Change in gingival condition as assessed using the Modified Lobene Gingival Index
Time frame: 26 weeks
Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index
Time frame: 26 weeks
Change in gingival condition as assessed using the Modified 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 8 Jun 2018.
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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, BDS principal investigator
Bristol Dental Hospital and School
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 and Comparator in people with Healthy, 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 8 inclusion and 18 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. 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 assessed using 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 8 Jun 2018.