RECRUITING

Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

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Conditions

Plaque Induced Gingivitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser in Addition to Toothbrushing-A 8-week Randomized Controlled Trial

Quick Facts

Study Start:2025-03-04
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06352645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants between the age of 18 - 70 years old.
  2. 2. Having at least 20 natural teeth in their dentition - excluding third molars.
  3. 3. In good overall systemic health, in the opinion of the investigator.
  4. 4. In good dental health with no visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
  5. 5. No hard or soft tissue lesions.
  6. 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. 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. 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.
  1. 1. Systemic disease self-reported that has an impact on periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
  2. 2. History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS).
  3. 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. 4. Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses).
  5. 5. Patients with visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
  6. 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. 7. Patients with PPD \>5 mm.
  8. 8. Need for antibiotic premedication for routine dental procedures.
  9. 9. Use of antibiotics within the last 3 months.
  10. 10. Daily use of steroids or non-steroid anti-inflammatory therapy within the last 3-months.
  11. 11. Patients who self-report pregnancy or lactation (hormonal changes that can affect periodontal health and aggravate existing periodontal disease).
  12. 12. Current smokers.
  13. 13. Inability or unwillingness to sign informed consent form.
  14. 14. Patients who do not agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns).
  15. 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. 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. 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. 18. Those not fluent in English

Contacts and Locations

Study Contact

Evangelos Papathanasiou
CONTACT
6176362408
dentalresearchadministration@tufts.edu
Ann-Marie Billig
CONTACT
6176363931
dentalresearchadministration@tufts.edu

Principal Investigator

Evangelos Papathanasiou
PRINCIPAL_INVESTIGATOR
Tufts University School of Dental Medicine

Study Locations (Sites)

Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts University

  • Evangelos Papathanasiou, PRINCIPAL_INVESTIGATOR, Tufts University School of Dental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-04
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-03-04
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Plaque Induced Gingivitis