Back to resultsA Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
Primary Purpose
Gingival Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluoride Toothpaste 1
Fluoride Toothpaste 2
Sponsored by
About this trial
This is an interventional prevention trial for Gingival Diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluoride Toothpaste 1
Fluoride Toothpaste 2
Arm Description
Toothpaste containing Sodium Fluoride at 1450 ppm F
Toothpaste containing Sodium Fluoride at 1450 ppm F
Outcomes
Primary Outcome Measures
Change in gingival condition as measured by the Modified Lobene Gingival Index
Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Change in plaque levels as measure by the Quigley and Hein Plaque index
Secondary Outcome Measures
change in gingival condition as measured by the Modified Lobene Gingival Index
change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Change in plaque levels as measured by the Quigley and Hein plaque index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03027908
Brief Title
A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
Official Title
A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
May 8, 2017 (Actual)
Study Completion Date
May 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride Toothpaste 1
Arm Type
Experimental
Arm Description
Toothpaste containing Sodium Fluoride at 1450 ppm F
Arm Title
Fluoride Toothpaste 2
Arm Type
Active Comparator
Arm Description
Toothpaste containing Sodium Fluoride at 1450 ppm F
Intervention Type
Other
Intervention Name(s)
Fluoride Toothpaste 1
Other Intervention Name(s)
A1
Intervention Description
Toothpaste containing 1450 ppm F as Sodium Fluoride
Intervention Type
Other
Intervention Name(s)
Fluoride Toothpaste 2
Other Intervention Name(s)
A2
Intervention Description
Toothpaste containing 1450 ppm F as Sodium Fluoride
Primary Outcome Measure Information:
Title
Change in gingival condition as measured by the Modified Lobene Gingival Index
Time Frame
13 weeks
Title
Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Time Frame
13 weeks
Title
Change in plaque levels as measure by the Quigley and Hein Plaque index
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
change in gingival condition as measured by the Modified Lobene Gingival Index
Time Frame
26 weeks
Title
change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
Time Frame
26 weeks
Title
Change in plaque levels as measured by the Quigley and Hein plaque index
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola X West, Professor
Organizational Affiliation
University of Bristol
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period
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