A clinical study on evaluation of a novel power toothbrush in eliminating dental plaque

Plaque removal efficiency of a multi-surface novel power toothbrush: a clinical study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91314641

Enrollment

Registered

2018-03-22

Start date

2016-02-01

Completion date

Unknown

Last updated

2021-03-15

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

Conditions

Gingivitis, dental plaque Oral Health

Interventions

Current interventions as of 21/04/2020: Right and left mouth will be randomly allocated to multi-surface power toothbrush (MS) (Y600, Newly, Newly tech Ltd, Zhejiang, China) or oscill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 24/02/2021: 1. In good general health 2. Right-handedness 3. University students (not dental students) 4. Mouth opening over three fingers 5. Teeth number 1 to 6 exist in each quadrant _____ Previous inclusion criteria from 04/08/2020 to 24/02/2021: 1. In good general health 2. Right-handedness 3. University students 4. Enough mouth opening and lingual frenulum to let the oral cavity contain an orthodontic photograph mirror 5. A minimum of 6 teeth in each quadrant _____ Previous inclusion criteria: 1. Aged from 18 to 22 years old 2. Normal lingual frenulum to let the oral cavity contain a dental mirror 3. A minimum of 6 teeth in each quadrant 4. In good general health

Exclusion criteria

Exclusion criteria: Current inclusion criteria as of 24/02/2021: 1. Inability to participate due to severe diseases 2. Cardiovascular diseases 3. Blood disease (hemophilia, pernicious anemia) 4. Hypertension 5. Metabolic diseases (diabetes mellitus) 6. Renal insufficiency 7. Infectious diseases (hepatitis A/B/C, HIV) 8. Seizure or neurological disorders 9. Need antibiotic prophylaxis due to immunosuppression or endocarditis; addiction (alcohol, drugs) 10. Allergic to toothpaste or other materials used in this study 11. Pregnancy 12. Presence of dental (carious lesion with cavity) and/or periodontal diseases (periodontal probing depth >3.5 mm with CPI probe) 13. Having taken antibiotics in the preceding 2 weeks 14. Having a crown, implant, or orthodontic appliances _____ Previous exclusion criteria: 1. Taken antibiotics in the preceding 2 weeks 2. Participants having a crown, implant or orthodontic appliances 3. Drinking alcohol or smoking tobacco within 4 hours before the experiment 4. Performing any oral hygiene care in the 12 hours before the visit, including brushing their teeth, chewing gum or using dental floss. In that period only small sips of water were allowed

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 04/08/2020: 1. Plaque removal efficiency at lingual, buccal, gingival marginal and proximal areas measured by RMNPI at 0,15,30,45 and 60 seconds for MS group and 0 ,30, 60 seconds for OR group 2. Plaque removal efficiency at occlusal areas measured by IPP at 0,15,30,45 and 60 seconds for MS group and 0 ,30, 60 seconds for OR group 3. User feedback on the toothbrush measured by questionnaires after two visits. Participants are asked to score the different aspect of using the two kinds of toothbrushes: noise, vibration, convenience, difficulty to brush the posterior tooth and the whole satisfaction _____ Previous primary outcome measure: 1. Plaque removal efficiency in the lingual, gingival marginal, buccal and approximal areas: plaque reduction rate = (plaquet0 – plaquetn) / plaquet0. t0 represents baseline, while tn represents different timepoints 2. User feedback on the toothbrush: questionnaires were distributed to participants, they are asked the following questions and score the different aspect of using the two kinds of toothbrushes: noise, vibration, convenience, difficulty to brush the posterior tooth and the whole satisfaction 3. Difference in plaque removing efficiency between upper and lower dentition: evaluated using t test Measured at baseline/first visit and 2 months/second visit	—

Measure

Time frame

Current primary outcome measure as of 04/08/2020: 1. Plaque removal efficiency at lingual, buccal, gingival marginal and proximal areas measured by RMNPI at 0,15,30,45 and 60 seconds for MS group and 0 ,30, 60 seconds for OR group 2. Plaque removal efficiency at occlusal areas measured by IPP at 0,15,30,45 and 60 seconds for MS group and 0 ,30, 60 seconds for OR group 3. User feedback on the toothbrush measured by questionnaires after two visits. Participants are asked to score the different aspect of using the two kinds of toothbrushes: noise, vibration, convenience, difficulty to brush the posterior tooth and the whole satisfaction _____ Previous primary outcome measure: 1. Plaque removal efficiency in the lingual, gingival marginal, buccal and approximal areas: plaque reduction rate = (plaquet0 – plaquetn) / plaquet0. t0 represents baseline, while tn represents different timepoints 2. User feedback on the toothbrush: questionnaires were distributed to participants, they are asked the following questions and score the different aspect of using the two kinds of toothbrushes: noise, vibration, convenience, difficulty to brush the posterior tooth and the whole satisfaction 3. Difference in plaque removing efficiency between upper and lower dentition: evaluated using t test Measured at baseline/first visit and 2 months/second visit

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Secondary

Measure	Time frame
Current secondary outcome measures 04/08/2020: Adverse effects (gingival bleeding) measured using an adverse event questionnaire just after the application and 1 week after visits _____ Previous secondary outcome measures: 1. Plaque removal efficiency between brushing time: method the same as the first visit 2. Adverse effects (gingival bleeding), measured using an adverse event questionnaire 1 week after visits 3. Difficulty in brushing the posterior teeth, assessed using questionnaires and t test measured at baseline/first visit and 2 months/second visit	—

Measure

Time frame

Current secondary outcome measures 04/08/2020: Adverse effects (gingival bleeding) measured using an adverse event questionnaire just after the application and 1 week after visits _____ Previous secondary outcome measures: 1. Plaque removal efficiency between brushing time: method the same as the first visit 2. Adverse effects (gingival bleeding), measured using an adverse event questionnaire 1 week after visits 3. Difficulty in brushing the posterior teeth, assessed using questionnaires and t test measured at baseline/first visit and 2 months/second visit

—

Countries

China

Contacts

Public ContactMingjie Wang

543347419@qq.com+86 (0)15397149195

Outcome results

None listed

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