Effect of a Toothpaste and Serum Compared to Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.

NCT02676440 | Completed

• 1 other identifier: ORL-GUM-2101
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Oral Health

Outcome Measures

Primary Outcomes (3)

• Change in gingival condition as assessed using the Modified Lobene Gingival Index

  13 weeks

• Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index

  13 weeks

• Change in gingival condition as assessed using the Modified Quigley and Hein plaque index

  13 weeks

Secondary Outcomes (3)

• Change in gingival condition as assessed using the Modified Lobene Gingival Index

  26 weeks

• Change in gingival condition as assessed using the Saxton and van der Ouderaa bleeding index

  26 weeks

• Change in gingival condition as assessed using the Modified Quigley and Hein plaque index

  26 weeks

Study Arms (2)

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

Other: Treatment

Comparator

OTHER

Silica toothpaste 1350ppm F as Sodium Fluoride

Other: Comparator

Interventions

Treatment OTHER

F13/T38

Treatment

Comparator OTHER

M26

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• University of Bristol Dental Hospital: collaborator

Study Sites (1)

Bristol Dental Hospital and School

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Nicola X West, BDS

  Bristol Dental Hospital and School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: February 8, 2016
• Study Start: July 3, 2015
• Primary Completion: December 14, 2015
• Study Completion: March 14, 2016
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

GB (1)