SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
Condition: Gingivitis; Periodontitis
MeSH terms: Gingivitis; Periodontitis
Study type: Interventional

Summary: 
      The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced
      Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse
      and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical
      to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium
      chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque
      and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste
      perception, malodor and calculus.
    

Detailed description: 
      Study Population A 10 week double-blinded, randomized clinical study will be conducted on 80
      subjects diagnosed with plaque induced gingivitis and/or chronic periodontitis. The study
      will take place at Saint Louis University Center for Advanced Dental Education and Southern
      Illinois University School of Dental Medicine.

      Research Design and Methods Visit 1 Subjects who sign the informed consent and medical
      history forms and meet the preliminary entrance criteria will be examined at baseline. All
      participants will be informed of the nature of the study, its purpose, and any possible
      risks. Subjects will also be informed as to the length of the study and the specific
      procedures that will be carried out. Subjects will be informed that this is a voluntary study
      and that they are free to withdraw from the study at any time.

      Clinical measurements of plaque and gingival indices will be taken. A gingival bleeding score
      will be determined. Examiners will be standardized for scoring.

      Gingival index (GI) will be measured using the Loe and Silness method (Loe and Silness 1963).
      The gingiva will be scored at six sites of each tooth (distobuccal, buccal, mesiobuccal,
      distolingual, lingual, mesiolingual) and given a score from 0 - 3. By adding the scores and
      dividing by the total number of sites, the GI for the patient will be obtained. The following
      criteria will be used for scoring:

      0 - Absence of inflammation

        1. - Mild inflammation: slight change in color, slight edema; no bleeding upon probing

        2. - Moderate inflammation: Redness, edema, and glazing; bleeding upon probing

        3. - Severe inflammation: Marked redness and edema; ulceration; tendency to spontaneous
           bleeding Sites with GI scores of 2 or 3 will be counted as bleeding. A whole mouth total
           gingival bleeding score will be calculated by summing the number of bleeding sites and
           dividing by the number of teeth.

      Plaque will be scored based on the Turesky modification of the Quigley-Hein Plaque Index (PI)
      (Turesky 1970). A score of 0 - 5 will be assigned to six sites of each tooth (distobuccal,
      buccal, mesiobuccal, distolingual, lingual, mesiolingual) following the use of a disclosing
      solution. The following criteria will be used:

      0 - No plaque

        1. - Isolated areas of plaque at gingival margin

        2. - Thin continuous band of plaque at gingival margin (up to 1 mm)

        3. - Band of plaque ˃ 1 mm and ˂ 1/3 of the tooth surface

        4. - Plaque covering 1/3 to ˂ 2/3 of tooth surface

        5. - Plaque covering ≥ 2/3 of tooth surface The Plaque Index for the entire mouth will be
           determined by dividing the total score by the number of surfaces examined.

      The Gingival Index will be measured prior to the Plaque Index. Teeth with gross caries and
      third molars will not be scored with either index.

      Extrinsic tooth stain will be scored on the facial surfaces of the 8 incisor teeth using a
      modification of the Lobene tooth stain index (SI) (Lobene 1968). Each incisor will be scored
      for stain area on a scale of 0-3. The sum of the stain scores for the subject will be used as
      that subject's stain score. Scores will be recorded from 0 to 3 as follows:

      0: no stain detected, only tooth color

        1. stain over 1/3 of the surface

        2. stain over 2/3 of the surface

        3. stain over more than 2/3 of the surface Supragingival calculus on the lingual surfaces
           of the six mandibular anterior teeth will be scored using the Volpe-Manhold calculus
           index (CI) (Volpe et al. 1965). The supragingival calculus in three defined planes on
           the lingual surface of each tooth will be measured using a periodontal probe. The
           measurements will be added and a mean subject score will be calculated.

      A complete periodontal examination will be performed for all subjects that meet the inclusion
      criteria. A panoramic radiograph will be taken for all subjects that do not have full mouth
      radiographs within the last year.

      Safety assessments will be made at each measurement visit. Assessment of the oral soft
      tissues will be conducted at each visit by visual examination of the oral cavity. All areas
      will be assessed and reported as normal or abnormal.

      Subject compensation: all subjects entered into the study will be given a gift card at the
      end of visit 2, visit 3 and visit 4.

      Visit 2 Visit 2 will occur within 4 weeks of Visit 1. Subjects entered into the study will be
      randomly assigned to three groups: Group 1 (Smart Mouth ACF), Group 2 (0.12% chlorhexidine)
      or Group 3 (placebo). All subjects will be given a complete dental prophylaxis to remove
      plaque, calculus, and stain. Written and verbal oral hygiene instructions will be given that
      include a regular regimen of brushing twice daily and flossing daily. All subjects will be
      assigned a commercially available ADA accepted toothbrush and dental floss. They will be
      given a 3 week supply of the assigned mouthrinse with written and verbal instructions for
      use. Subjects will be instructed not to have their teeth professionally cleaned prior to
      study completion.

      All mouthrinses will be in a plain package and dispensed by the faculty investigators. The
      package will be labeled with a code to indicate the product. Only the faculty investigators
      will have access to the code information. Directions for use will be contained in the
      package. The examiners will not see the product. The examiners will give instructions for
      mouthrinse use, but they will not be aware which rinse the subjects are using. Each product
      will contain two solutions which are mixed prior to use.

      Visit 3 Subjects will be examined 3 weeks after visit 2. All clinical measurements will be
      repeated. Each subject will return with any unused rinse or two empty bottles of rinse.
      Compliance will be determined by regulating the amount of rinse dispensed on a 3 week basis
      and by the measurement of any unused rinse at the end of two 3 week periods. Additional rinse
      will be given to each subject after visit 3 for use until the final visit.

      Visit 4 Subjects will be examined 3 weeks after visit 3 (6 weeks from visit 2). Clinical
      measurements will be repeated. Each subject will return with any unused rinse or two empty
      bottles of rinse. Compliance will be determined by the measurement of any unused rinse at the
      end of the study.

      Subjects will be given a survey to answer questions about their experience with the
      mouthrinse. Prophylaxis may be performed at this visit.

      Following the study, the subjects will be treated by their provider's discretion.
    

Intervention name(s): SmartMouth Clinical DDS mouthrinse; 0.12% chlorhexidine rinse; Placebo rinse
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects use SmartMouth Clinical DDS mouth rinse for six weeks.; Subjects use chlorhexidine mouth rinse for six weeks.; Subjects use placebo mouth rinse for six weeks. The placebo rinse is the same as SmartMouth Clinical DDS, but without the active ingredients.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment