NCT02709785.

Study name	SmartMouth Advanced Clinical Formula clinical research design protocol
Methods	Trial design: parallel, (3 arms ‐ 2 arms relevant to this review) Location: Saint Louis University Center for Advanced Dental Education, Saint Louis, Missouri, USA and Southern Illinois University School of Dental Medicine, Alton, Illinois, USA Number of centres: 2 Study duration: March 2016 to June 2017. Study duration 10 weeks. Duration of rinsing 6 weeks
Participants	Participants: adults with gingivitis or chronic periodontitis Inclusion criteria: subjects between the ages of 18 to 80, with a diagnosis of gingivitis or chronic periodontitis, mean GI ≥ 0.4 and PI ≥ 1.0, subjects that are in good medical health at time of the study, at least 20 permanent natural teeth Exclusion criteria: use of local or systemic antibiotics during the course of the study, subjects that are pregnant or nursing mothers, undergoing orthodontic therapy, subjects wearing removable prostheses, subjects taking medication which is altering the gingiva or causing inflammation, gingival overgrowth, history of sensitivity or suspected allergies following the use of oral hygiene products, subjects taking anti‐inflammatory or anticoagulant medications that would alter the gingiva and promote bleeding, subjects that require antibiotic prophylaxis prior to dental treatment, subjects that have acute dental problems requiring immediate treatment Baseline gingivitis: GI ≥ 0.4 (Löe & Silness 1963) Age at baseline: 18‐80 years are eligible Prophylaxis: all subjects will be given a complete dental prophylaxis to remove plaque, calculus, and stain OHI: written and verbal OHI 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 Number to be randomised: 85 (each group will have at least 25 subjects)
Interventions	0.12% chlorhexidine rinse versus SmartMouth Advanced Clinical Formula (ACF) rinse versus placebo rinse
Outcomes	Gingivitis: gingival inflammation: GI Löe & Silness 1963; gingival bleeding (GI scores 2 and 3); Turesky modification of the Quigley and Hein Plaque Index, Turesky 1970. Extrinsic tooth staining: modification of the Lobene Tooth Stain Index, Lobene 1968. Supragingival calculus on the lingual surfaces of the 6 mandibular anterior teeth will be scored using the Volpe‐Manhold Calculus Index, Volpe 1965. Safety assessments and assessment of the oral soft tissues will be conducted at each visit by visual examination of the oral cavity. Evaluation of taste perception, malodour via questionnaire
Starting date	March 2016
Contact information	Contact: David D Miley, Saint Louis University Center for Advanced Dental Education, Saint Louis, Missouri, USA
Notes	Sponsor: Saint Louis University Collaborator: Triumph Pharmaceuticals NCT02709785

ADA = American Dental Association; GI = Gingival Index; PI = Plaque Index; OHI = oral hygiene instruction.