A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Experimental Dentifrice: Stannous Fluoride; COREGA Denture Foaming Cleanser; Mouth rinse: Sodium Fluoride
Intervention description: Participants will be instructed to dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion containing 0.454% w/w Stannous fluoride for 2 minutes twice daily (morning and evening) for 12 weeks.; Participant will clean their denture using 2 pumps of the denture cleansing foam and a denture cleaning brush for 90 timed seconds outside of the mouth twice daily (morning and evening) for 12 weeks.; Participants will take 10 ml of the mouth rinse containing 90 ppm sodium fluoride and swished around the mouth for 1 minute twice daily (morning and evening) for 12 weeks.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Tin Fluorides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the effectiveness of usage of a range of oral
      products (toothpaste, mouth rinse, denture cleanser) on the oral health of partial denture
      wearers compared to existing oral hygiene habits.The hypothesis is that there is no treatment
      difference in the oral health when using the range of products for 12 weeks compared to no
      intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant provision of a signed and dated informed consent document indicating that
             the participant has been informed of all pertinent aspects of the study before any
             assessment is performed.

          -  A participant who is willing and able to comply with scheduled visits, treatment plan,
             and other study procedures.

          -  A participant with good general and mental health with, in the opinion of the
             investigator or medically qualified designee no clinically significant or relevant
             abnormalities in medical history or upon oral examination, or a condition, that would
             impact the participant's safety, well being or the outcome of the study, if they were
             to participate in the study.

          -  A participant who is a cell phone owner with text messaging capabilities.

          -  Dental Criteria:

               1. A participant with a minimum of 4 natural teeth in each arch.

               2. A participant with a minimum of 30 scorable surfaces for MGI (Modified Gingival
                  Index), BI (Bleeding Index), OHI (oral hygiene index) and TPI (Turesky Plaque
                  Index). (A scorable surface is defined as a surface that has at least 2/3 of the
                  surface gradable for each clinical index. Third molars, orthodontically
                  banded/bonded, fully crowned or extensively restored or grossly carious teeth are
                  not included in the tooth or scorable surface count. Third molars can be included
                  if, as a result tooth loss, they are functioning as second molars. Tooth surfaces
                  with calculus deposits which, in the opinion of the clinical examiner, would
                  interfere with the assessments of the selected clinical indices are also
                  excluded.)

               3. A participant with a minimum of 2 scorable abutment teeth, defined as teeth
                  proximal to the RPD (removable partial denture) or impinged by an RPD clasp or
                  rest.

               4. A participant with generalized mild-moderate plaque-induced gingivitis present at
                  the screening visit (in the opinion of the clinical examiner from a gross visual
                  examination).

               5. A participant with a mean whole mouth BI >= (greater than or equal to) 0.1 to =<
                  (less than or equal to) 1.3, a mean whole mouth MGI >= 1.75 to =< 2.30 and a mean
                  overall TPI score > (greater than) 1.5 at the Baseline visit.

               6. A participant who habitually wears one conventional removable partial denture
                  constructed of acrylic or cobalt chrome which is acceptable according to the well
                  made and well-fit assessments.

        Exclusion Criteria:

          -  A Participant who is an employee of the investigational site, either directly involved
             in the conduct of the study or a member of their immediate family; or an employee of
             the investigational site otherwise supervised by the investigator; or, a GSK CH
             (GlaxoSmithKline Consumer Healthcare) employee directly involved in the conduct of the
             study or a member of their immediate family.

          -  A participant who has participated in other studies (including non-medicinal studies)
             involving investigational product(s) within 30 days prior to study entry and/or during
             study participation.

          -  A participant with an acute or chronic medical or psychiatric condition that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  A participant who is pregnant (self-reported) or intending to become pregnant over the
             duration of the study.

          -  A participant who is breastfeeding.

          -  A participant with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  A participant who smokes (defined as having smoked or used nicotine products
             (including ecigarettes, chewing tobacco, gutkha, pan- containing tobacco, nicotine
             replacement therapies) during the previous 12 months).

          -  A participant who is unwilling or unable to comply with the Lifestyle guidelines
             described in this protocol.

          -  A participant with a recent history (within the last year) of alcohol or other
             substance (e.g. illicit drug) abuse.

          -  A participant who has previously been enrolled in this study.

          -  A participant who, in the opinion of the investigator, should not participate in the
             study.

          -  Medication Exclusions:

               1. A participant who has taken or is currently taking antibiotics at the Screening
                  visit or in the 14-day period prior to the Baseline visit or requiring antibiotic
                  use prior to dental prophylaxis or other dental procedure.

               2. A participant who is currently taking, on a regular daily basis, an
                  anti-inflammatory, anticoagulant or any other systemic medication (e.g. calcium
                  channel blockers, aspirin therapy, ibuprofen, warfarin) or has a medical
                  condition which, in the opinion of the Investigator, could affect the gingival
                  condition.

               3. A participant who has used an antibacterial mouth rinse (e.g. chlorhexidine,
                  Listerine), dentifrice (e.g. stannous fluoride) or use of any oral care product
                  that, in the opinion of the investigator, could interfere with plaque
                  accumulation or clinical measures within 28 days preceding the baseline visit.

          -  Oral and Dental Exclusions

               1. A participant with a condition or who is taking medication which, in the opinion
                  of the investigator is causing xerostomia.

               2. A participant who, in the opinion of the investigator, has a periodontal
                  condition that could be adversely affected by lack of immediate periodontal
                  intervention.

               3. A participant who has received treatment for periodontal disease within 12 months
                  of Screening and/or scaling or root surface debridement within 3 months of
                  Screening, which, in the opinion of the Investigator, could compromise study
                  outcomes or the oral health of the participant if they were to participate in the
                  study.

               4. A participant who has numerous restorations in a poor state of repair.

               5. A participant with a severe oral condition (e.g. acute necrotizing ulcerative
                  gingivitis, severe active caries) that could, in the opinion of the investigator,
                  compromise study outcomes or the oral health of the participant if they were to
                  participate in the study.

               6. A participant who has had tooth bleaching treatment or a dental prophylaxis
                  within 4 weeks of screening.

               7. A participant who frequently use commercially-available denture cleansers, e.g.
                  denture cleanser tablets, denture cleaning pastes (defined as those participants
                  who use a commercially available cleanser more frequently than once per month).

               8. A participant who currently use denture adhesives (defined as those participants
                  who have used an adhesive in the 28 day period prior to baseline).

               9. A participant who displays evidence of dental fluorosis that might interfere with
                  clinical assessments, as determined by the investigator.

              10. A participant with gingivitis which, in the opinion of the investigator, is not
                  expected to respond to treatment with an over-the-counter dentifrice.

              11. A participant who has an overdenture or orthodontic appliance.