Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

Plaque Induced Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352645
• Other study ID #: STUDY00004879
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Tufts University
• Contact: Evangelos Papathanasiou
• Phone: 6176362408
• Email: dentalresearchadministration[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Plaque Induced Gingivitis

Intervention

Device:
• Bixdo Ultra Compact Water Flosser
Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
• Manual 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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Guangdong Bixdo Health Technology Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Goyal CR, Lyle DM, Qaqish JG, Schuller R. The addition of a water flosser to power tooth brushing: effect on bleeding, gingivitis, and plaque. J Clin Dent. 2012;23(2):57-63. — View Citation

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Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available. — View Citation

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Lyle DM, Qaqish JG, Goyal CR, Schuller R. Efficacy of the Use of a Water Flosser in Addition to an Electric Toothbrush on Clinical Signs of Inflammation: 4-Week Randomized Controlled Trial. Compend Contin Educ Dent. 2020 Mar 1;41(3):170-177. Epub 2020 Jan 1. — View Citation

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Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12. — View Citation

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Tyler D, Kang J, Goh HH. Effectiveness of Waterpik(R) for oral hygiene maintenance in orthodontic fixed appliance patients: A randomised controlled trial. J Orthod. 2023 Dec;50(4):367-377. doi: 10.1177/14653125231173708. Epub 2023 May 19. — View Citation

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Xu X, Zhou Y, Liu C, Zhao L, Zhang L, Li H, Li Y, Cheng X. Effects of water flossing on gingival inflammation and supragingival plaque microbiota: a 12-week randomized controlled trial. Clin Oral Investig. 2023 Aug;27(8):4567-4577. doi: 10.1007/s00784-023-05081-4. Epub 2023 May 25. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation Reduction	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.	8 weeks
Primary	Bacterial plaque removal	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	8 weeks

External Links

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