Condition category
Oral Health
Date applied
25/02/2018
Date assigned
22/03/2018
Last edited
22/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to find out whether a multi-surface toothbrush reduces plaque at the same rate as an oscillation rotation toothbrush.

Who can participate?
Healthy volunteers aged 18 to 22

What does the study involve?
Every participant has two visits, at the first visit they use an oscillation rotation toothbrush (OR) in the left half of their mouth for 1 minute and the multi-surface toothbrush (MS) in the right for 1 minute. At the second visit, they use OR in the right and MS in the left. The participant’s plaque is assessed without knowing which toothbrush was used. Participants are followed up for 1 week to investigate side effects such as gingival (gum) bleeding.

What are the possible benefits and risks of participating?
Multi-surface power toothbrushes could improve the removal of plaque in areas that are hard to clean and shorten brushing time. Users could achieve almost optimal oral hygiene by using the multi-surface toothbrush without needing to know the professional technique. It could help to save the time the dental hygienist spends on patient education. Possible risks include gingival bleeding and gingival harm.

Where is the study run from?
Stomatology Hospital affiliated to Zhejiang Chinese Medical University (China)

When is the study starting and how long is it expected to run for?
February 2016 to July 2016

Who is funding the study?
Zhejiang Chinese Medical University (China)

Who is the main contact?
1. Dr Yuanna Zheng (scientific)
zyn218@126.com
2. Mr Mingjie Wang (public)
543347419@qq.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yuanna Zheng

ORCID ID

Contact details

Mailbox 97
Binwen Road 548
Binjiang District
Hangzhou
310000
China
+86 (0)13968149843
zyn218@126.com

Type

Public

Additional contact

Mr Mingjie Wang

ORCID ID

http://orcid.org/0000-0003-2225-2471

Contact details

Binwen Road 548
Binjiang District
Hangzhou
310000
China
+86 (0)15397149195
543347419@qq.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

832219A00601

Study information

Scientific title

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

Acronym

Study hypothesis

The multi-surface toothbrush reduces plaque at the same rate as with an oscillation rotation toothbrush.

Ethics approval

Ethics board of stomatology hospital affiliated to Zhejiang Chinese Medical University, 01/02/2016, ref: No. 20160201

Study design

Interventional split-mouth single-center study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Gingivitis, dental plaque

Intervention

Every participant has two visits, at the first visit they use an oscillation rotation toothbrush (OR) in the left half of the mouth for 1 minute and the multi-surface toothbrush (MS) in the right for 1 minute. At the second visit, they use OR in the right and MS in the left.

Two staff scored the plaque without knowing the allocation of toothbrush. Participants are followed up for one week to investigate adverse events like gingival bleeding and damage to gingival margin.

Intervention type

Device

Phase

Drug names

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

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

Overall trial start date

01/02/2016

Overall trial end date

01/07/2016

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/02/2016

Recruitment end date

01/03/2016

Locations

Countries of recruitment

China

Trial participating centre

Stomatology Hospital affiliated to Zhejiang Chinese Medical University
No. 529, Binwen Rd., Binjiang District
Hangzhou
310000
China

Sponsor information

Organisation

Zhejiang Chinese Medical University

Sponsor details

School of Stomatology
Binwen Road 548
Binjiang District
Hangzhou
310053
China

Sponsor type

University/education

Website

http://zzdkq.zcmu.edu.cn/page/hf/index.jsp

Funders

Funder type

University/education

Funder name

Zhejiang Chinese Medical University

Alternative name(s)

ZCMU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

China

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mingjie Wang (543347419@qq.com) for five years.

Intention to publish date

22/03/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes