Phase
Condition
Periodontitis
Treatment
Manual toothbrush
Bixdo Ultra Compact Water Flosser
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants between the age of 18 - 70 years old.
Having at least 20 natural teeth in their dentition - excluding third molars.
In good overall systemic health, in the opinion of the investigator.
In good dental health with no visible carious lesions, periodontitis, orthodonticappliances, or removable partial dentures.
No hard or soft tissue lesions.
Subjects with moderate or severe plaque-induced gingivitis: a minimum of 50% BOP, 1.75 modified gingival index (MGI), and 0.60 Rustogi Modification of the Navy PlaqueIndex (RMNPI) and PPD ≤5 mm.
Subjects who agree to delay dental prophylaxis, elective dental treatment, andcosmetic procedures (i.e. tooth whitening, crowns) for the duration of the study
For the main study only: Subjects who agree to refrain from using any non-studydental device or oral care products for the duration of the study, return forscheduled visits, and comply with all study procedures.
Exclusion
Exclusion Criteria:
Systemic disease self-reported that has an impact on periodontal status (e.g.,diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS).
History of immunosuppressive chemotherapy or history of any disease known toseverely compromise immune function (e.g., cytomegalovirus infection) within thelast 5 years.
Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina,abscesses).
Patients with visible carious lesions, periodontitis, orthodontic appliances, orremovable partial dentures.
Patients with mild plaque-induced gingivitis: < 50% BOP, <1.75 modified gingivalindex (MGI), and <0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm.
Patients with PPD >5 mm.
Need for antibiotic premedication for routine dental procedures.
Use of antibiotics within the last 3 months.
Daily use of steroids or non-steroid anti-inflammatory therapy within the last 3-months.
Patients who self-report pregnancy or lactation (hormonal changes that can affectperiodontal health and aggravate existing periodontal disease).
Current smokers.
Inability or unwillingness to sign informed consent form.
Patients who do not agree to delay dental prophylaxis, elective dental treatment,and cosmetic procedures (i.e. tooth whitening, crowns).
For the main study only: Patients who do not agree to refrain from using anynon-study dental device or oral care products, return for scheduled visits, andcomply with all study procedures.
Anything that would place the individual at increased risk or preclude theindividual's full compliance with or completion of the study at the discretion ofthe investigators.
For the main study only: Patients who need assistance from others to perform theirdaily oral hygiene practices or read the manual of instructions that come with theat-home product.
Those not fluent in English
Study Design
Connect with a study center
Tufts University School of Dental Medicine
Boston, Massachusetts 02111
United StatesActive - Recruiting
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