Plaque Induced Gingivitis
Conditions
Brief summary
The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal.
Interventions
DEVICEBixdo Ultra Compact Water Flosser
Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
DEVICEManual toothbrush
For those in the control group, they will be asked to use only the study-provided manual toothbrush, twice a day for 8 weeks.
Sponsors
Tufts University
Guang Dong Bixdo Health Technology Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Participants between the age of 18 - 70 years old. 2. Having at least 20 natural teeth in their dentition - excluding third molars. 3. In good overall systemic health, in the opinion of the investigator. 4. In good dental health with no visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures. 5. No hard or soft tissue lesions. 6. 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 Plaque Index (RMNPI) and PPD ≤5 mm. 7. Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns) for the duration of the study 8. For the main study only: Subjects who agree to refrain from using any non-study dental device or oral care products for the duration of the study, return for scheduled visits, and comply with all study procedures.
Exclusion criteria
1. Systemic disease self-reported that has an impact on periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis). 2. History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS). 3. History of immunosuppressive chemotherapy or history of any disease known to severely compromise immune function (e.g., cytomegalovirus infection) within the last 5 years. 4. Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses). 5. Patients with visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures. 6. Patients with mild plaque-induced gingivitis: \< 50% BOP, \<1.75 modified gingival index (MGI), and \<0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm. 7. Patients with PPD \>5 mm. 8. Need for antibiotic premedication for routine dental procedures. 9. Use of antibiotics within the last 3 months. 10. Daily use of steroids or non-steroid anti-inflammatory therapy within the last 3-months. 11. Patients who self-report pregnancy or lactation (hormonal changes that can affect periodontal health and aggravate existing periodontal disease). 12. Current smokers. 13. Inability or unwillingness to sign informed consent form. 14. Patients who do not agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns). 15. For the main study only: Patients who do not agree to refrain from using any non-study dental device or oral care products, return for scheduled visits, and comply with all study procedures. 16. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study at the discretion of the investigators. 17. For the main study only: Patients who need assistance from others to perform their daily oral hygiene practices or read the manual of instructions that come with the at-home product. 18. Those not fluent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation Reduction | 8 weeks | At each of the three study visits, the examiners will conduct a periodontal clinical exam, following standard of care procedure, to evaluate the levels of inflammation in the gingiva of subjects in both the intervention and control groups. |
| Bacterial plaque removal | 8 weeks | At each of the three study visits, subjects will be given dental plaque erythrosine disclosing agents (Sunstar GUM® RED-COTE®) to assess the level of plaque on the subjects teeth |
Countries
United States
Contacts
CONTACTMabi Singh
CONTACTAnn-Marie Billig
PRINCIPAL_INVESTIGATORMabi Singh
Tufts University School of Dental Medicine
Outcome results
None listed