A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Experimental Dentrifrice; Positive control dentifrice; Negative control dentifrice
Intervention description: Toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride; Dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride; Dentifrice containing 1100ppm fluoride as sodium fluoride (Crest Cavity Protection)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate,
      sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum
      healing. This Proof-of-Principle study will investigate the efficacy of an experimental
      dentifrice compared to a regular fluoride dentifrice, and also whether this provides any
      additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium
      bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.
    

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.

          -  Participant who is willing and able to comply with scheduled visits, treatment plan,
             and other study procedures.

          -  Participant in good general and mental health with, in the opinion of the investigator
             or medically qualified designee, no clinically significant/relevant abnormalities in
             medical history or upon oral examination, or condition, that would impact the
             participant's safety, wellbeing or the outcome of the study, if they were to
             participate in the study, or affect the individual's ability to understand and follow
             study procedures and requirements.

          -  Female participant of childbearing potential must have negative pregnancy test results
             at screening and baseline.

          -  Female participant of childbearing potential and at risk for pregnancy must agree to
             use a highly effective method of contraception throughout the study and for 5 days
             after the last dose of assigned treatment. A female participant who is of childbearing
             potential must agree to use a highly effective method of contraception consistently
             and correctly for the duration of the active study period and for at least 5 days
             after the last dose of investigational product..

        At Screening (Visit 1):

          1. Participant with at least 20 natural, permanent teeth.

          2. Participant with at least 40 evaluable surfaces for MGI, BI and TPI. An evaluable
             surface is defined as having 2/3rds of the natural tooth surface gradable for the
             selected clinical indices. The following should not be included in the evaluable
             surface count- third molars; fully crowned/extensively restored, grossly carious,
             orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits
             which, in the opinion of the clinical examiner, would interfere with the baseline
             assessments of the selected clinical indices.

          3. Participant with generalized mild- moderate plaque-induced gingivitis, in the opinion
             of the clinical examiner, as confirmed by a gross visual examination at the Screening
             Visit.

        At Baseline - Prior to Dental Prophylaxis (Visit 2):

          1. Participant with ongoing hard tissue eligibility and, in the opinion of the clinical
             examiner, at least 40 evaluable surfaces.

          2. Participant with mean whole mouth MGI between 1.75 and 2.30.

          3. Participant with mean whole mouth TPI score ≥1.5.

          4. Participant with a minimum of 20 bleeding sites.

             Exclusion Criteria-

               -  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 GlaxoSmithKline Consumer Healthcare (GSKCH) employee directly involved in
                  the conduct of the study or a member of their immediate family.

               -  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.

               -  Participant with, in the opinion of the investigator or medically qualified
                  designee, an acute or chronic medical or psychiatric condition or laboratory
                  abnormality 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 or medically qualified
                  designee would make the participant inappropriate for entry into this study.

               -  Participant with any other clinical serious or unstable conditions (e.g.
                  cardiovascular diseases, diabetes, liver disorders and kidney disorders) which
                  may affect study outcomes and/ or participant safety.

               -  Participant who is a pregnant female (including a woman who has a positive urine
                  pregnancy test; pregnancy testing will be carried out for all female participants
                  who are of childbearing potential) or is intending to become pregnant over the
                  duration of the study.

               -  Participant who is a breastfeeding female.

               -  Participant with known or suspected intolerance or hypersensitivity to the study
                  materials (or closely related compounds) or any of their stated ingredients.

               -  Participant unwilling or unable to comply with the Lifestyle Considerations
                  described below:

                    1. Dental Product/Treatment and Oral Hygiene Restrictions From Screening (Visit
                       1) to the Participant's Last Study Visit • Participants should not use any
                       other oral care products (e.g. dentifrices, toothbrushes, mouthrinses) other
                       than those provided during the study.

                       • Participants should not carry out any interproximal dental cleaning. Use
                       of dental floss, toothpicks, waterpicks or inter-dental brushes is
                       prohibited (except for the removal of impacted food with non-antimicrobial
                       products only).

                       • Participants should delay any non-emergency dental treatment until after
                       study completion (including dental prophylaxis).

                       Before Clinical Efficacy Assessment Visits: Baseline (Visit 2) to Last Study
                       Visit • Participants should refrain from oral hygiene procedures for 12
                       hours ((+6hr, -2hr) before their visit and attend the study site with
                       overnight plaque growth.

                    2. Dietary and Smoking Restrictions From Screening (Visit 1) to the
                       Participant's Last Study Visit • Participants should not chew gum or consume
                       any confectionery containing xylitol (e.g. mints).

                         -  Participants must abstain from smoking/ use of tobacco products (e.g.
                            chewing tobacco, gutkha, pan containing tobacco, nicotine-based
                            e-cigarettes).

             Before Clinical Efficacy Assessment Visits: Baseline (Visit 2) to Last Study Visit

             • Participants must abstain from all food and drink (except water) for at least 4hrs
             prior to their scheduled assessment visits and until all assessments are complete
             during visit days. Water is permitted until 1 hour prior to their scheduled study
             visits.

             - Participant who is a current smoker or an ex- smoker who stopped within 6 months of
             Screening.

             - Participant who currently uses smokeless forms of tobacco (e.g. chewing tobacco,
             gutkha, pan containing tobacco, nicotine-based e-cigarettes).

             - Participant with diagnosed xerostomia or taking any medication that in the view of
             the investigator causes xerostomia.

             - Participant with a medical condition which may directly influence gingival bleeding.

               -  Participant with a bleeding disorder that may affect study outcomes and/ or
                  participant safety.

               -  Recent history (within the last year) of alcohol or other substance abuse.

               -  Participant with a severe oral condition (e.g. acute necrotizing ulcerative
                  gingivitis or oral or peri-oral ulceration including herpetic lesions) that
                  would, in the opinion of the investigator, compromise study outcomes or the oral
                  health of the participant/ examiner if they were to participate in the study.

               -  Presence of a tongue or lip piercing, or any other oral feature that could
                  interfere with the usage of a toothbrush.

               -  Medication Exclusions

             At Screening (Visit 1):

          1. Participant currently taking antibiotics or requiring antibiotic use prior to dental
             prophylaxis or other dental procedures.

          2. Participant currently taking an anti-inflammatory medication which, in the opinion of
             the Investigator, could affect gingival condition.

          3. Participant currently taking a systemic medication (e.g. anti-inflammatory,
             anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the
             opinion of the Investigator, could affect plaque/ gingival condition (e.g. ibuprofen,
             aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).

             - Medication exclusions

             At Baseline (Visit 2):

          1. Participant who has taken (in the previous 14 days), any antibiotics.

          2. Participant who has taken (in the previous 14 days) a systemic medication (e.g.
             antiinflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy
             which, in the opinion of the Investigator, could affect plaque/ gingival condition
             (e.g. ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).

          3. Participant who has used an antibacterial dentifrice or mouthwash (e.g. chlorhexidine)
             or any oral care product that in the view of the investigator could interfere with
             plaque formation or measures of gingivitis, in the period between Screening and the
             Baseline

             - Periodontal Exclusions

        a. Participant with signs of active periodontitis. b. Participant with gingivitis which, in
        the opinion of the investigator, is not expected to respond to treatment with an
        over-the-counter dentifrice.

        c. Participant who is receiving or has received treatment for periodontal disease
        (including surgery) within 12 months of Screening.

          -  Dental Exclusions

               1. Participant with 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.

               2. Participant with dentures (partial or full).

               3. Participant with an orthodontic appliance (bands, appliances or fixed/ removable
                  retainers).

               4. Participant who has received orthodontic therapy within 12 months of Screening.

               5. Participant with numerous restorations in a poor state of repair.

               6. Participant with any dental condition (e.g. overcrowding) 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.

               7. Participant who has had dental prophylaxis within 12 weeks of Screening.

               8. Participant who has had teeth bleaching within 12 weeks of Screening.

               9. Participant with high levels of extrinsic stain or calculus deposits that might
                  interfere with plaque assessments.

          -  Participant who has previously been enrolled in this study.

          -  Participant who, in the opinion of the investigator or medically qualified designee,
             should not participate in the study.