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Study on the safety and efficacy of a new sweeping-vibrating electric toothbrush for daily oral hygiene cleaning —— a single-center, examiner-blind, parallel design randomized clinical trial

Study on the safety and efficacy of a new sweeping-vibrating electric toothbrush for daily oral hygiene cleaning —— a single-center, examiner-blind, parallel design randomized clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097127
Enrollment
Unknown
Registered
2025-02-13
Start date
2025-02-13
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gingivitis

Interventions

Experimental group:Brush teeth daily using a sweeping-vibrating toothbrush according to the brushing instructions.
Control group 1:Brush teeth daily using a manual toothbrush according to the brushing instructions.
Control group 2:Brush teeth daily using a sonic electric toothbrush according to the brushing instructions.
Control group 3:Brush teeth daily using a oscillating-rotating toothbrush according to the brushing instructions.

Sponsors

Nanjing Stomatological Hospital, Affiliated Hospital of Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years old, with good overall health, capable of understanding and cooperating with the study, and able to independently perform toothbrushing according to the instructions provided by the researchers. 2. Generally periodontal health. 3. At least 20 evaluable teeth, excluding third molars, teeth with orthodontic brackets or attachments, dental bridges, crowns, or implants. 4. No periodontal treatment received within the past 6 months. 5. No visible supragingival calculus (tartar above the gumline). 6. Informed consent: The participant fully understands the benefits and risks of the study, is willing to participate, and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe periodontal disease. 2. Individuals undergoing orthodontic treatment, dental implant placement, pregnant or breastfeeding women. 3. Presence of unhealed oral mucosal lesions or untreated dental caries. 4. Currently participating or planning to participate in clinical trials at this institution or any other institution. 5. Conditions requiring long-term medication, including but not limited to hypertension, diabetes, post-tumor surgery, etc. 6. Factors that cause plaque retention and cannot be removed by brushing, such as overhanging fillings, poor restorations, etc. 7. Other circumstances deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
plaque index, PLI;gingival index, GI;Gingival bleeding index, GBI;Calculus Index-Simplified, CI-S;

Secondary

MeasureTime frame
Gingival recession;Tooth hypersensitivity;Plaque cleaning efficiency;

Countries

China

Contacts

Public ContactZhao Sufeng

Nanjing Stomatological Hospital, Affiliated Hospital of Medical School

zsfnjkq@163.com+86 139 1392 1344

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026