UMIN-CTR Clinical Trial

Public title

Evaluation of clinical usefulness of Prinia Smile, GC

Acronym

Evaluation of clinical usefulness of Prinia Smile, GC

Scientific Title

Evaluation of clinical usefulness of Prinia Smile, GC

Scientific Title:Acronym

Evaluation of clinical usefulness of Prinia Smile, GC

Region

Japan

Condition

Gingivitis and periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will check whether PCR (Plaque Control Record) 20%, which is one of the evaluation criteria when treating periodontal disease, can be achieved by TBI(teeth brushing instructiono) with an electric toothbrush.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Check if PCR(Plaque Control Record) 20% was achieved

Key secondary outcomes

Confirm that no adverse events such as pain occurred

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Get periodontal examination before using electric toothbrush

Interventions/Control_2

Fix the frequency of the electric toothbrush used

Interventions/Control_3

Change the frequency of the electric toothbrush used

Interventions/Control_4

Changing the head of the electric toothbrush used

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Age:Patients who are 20 years of age or older when obtaining consent
(2)Gender:Any
(3)Hospitalization / Outpatient: Outpatient only
(4)Periodontal examination:Patients who have been diagnosed as having moderate or more chronic periodontitis or invasive periodontitis as a result of periodontal examination
(5)Patients who have received sufficient explanation for participation in this study, and who have fully understood and consented to the document by their own will.
(6)Systemic periodontal disease treatment has not been received in the past, or even if it has been received, plaque control is poor and there is a wide range of recurrence sites.
(7)There are more than 20 remaining teeth in all jaws.
8)Antibacterial drugs.You have not taken any antibacterial drugs within the past 3 months on the registration date.

Key exclusion criteria

(1)Patients with diabetes that cannot be controlled
(2)Patients with severe heart disease
(3)Patients with severe liver and renal dysfunction
(4)Patients taking antibody drugs or anti-inflammatory drugs for autoimmune diseases
(5)Other patients who are deemed inappropriate by the research director

Target sample size

40

Name of lead principal investigator

1st name	yamashita
Middle name
Last name	yasunori

Organization

Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University

Division name

Department of Periodontology and Endodontology

Zip code

8528501

Address

1-7-1, sakamoto, nagasaki city, nagasaki prefecture

TEL

095-819-7643

Email

yamachanpon@nagasaki-u.ac.jp

Name of contact person

1st name	yamashita
Middle name
Last name	yasunori

Organization

Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University

Division name

Department of Periodontology and Endodontology

Zip code

8528501

Address

1-7-1, sakamoto, nagasaki , nagasaki

TEL

095-819-7643

Homepage URL

Email

yamachanpon@nagasaki-u.ac.jp

Institute

Department of Periodontology and Endodontology, Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University

Institute

Department

Personal name

Organization

Department of Periodontology and Endodontology, Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Department of Periodontology and Endodontology, Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University

Organization

nagasaki university

Address

1-7-1, sakamoto, nagsaki, nagasaki

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

長崎大学病院

Date of disclosure of the study information

2019

Year

10

Month

18

Day

URL releasing protocol

https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202002259078594314

Publication of results

Unpublished

URL related to results and publications

https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202002259078594314

Number of participants that the trial has enrolled

40

Results

The Prinia Smile (G.C. Co., Ltd.) is a sonic vibrating toothbrush that can be used in various oral environments with three different modes, including the gentle vibration S-soft mode, and three different replacement brushes. The purpose of this study was to evaluate the safety and efficacy of Pliny Smile when used for plaque control.
The overall mean PCRs were PCR1: 51%, PCR2: 42%, and PCR3: 25%; compared to PCR1, PCR2 showed a significant decrease only in group B, and PCR3 in all groups.

Results date posted

2023

Year

11

Month

29

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Subjects
Patients who visited Nagasaki University Hospital for periodontal treatment will be included in the study.
Selection Criteria
Patients who meet all of the following criteria will be included in the study.
(1) Age: Patients who are 20 years of age or older at the time consent is obtained.
(2) Gender: Any gender
(3) Inpatient/outpatient: Outpatient only
(4) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
(5) Patients with 20 or more remaining teeth
(6) PCR>20
Reasons for setting
(1) Patients over 20 years of age are at high risk of developing periodontal disease.
(2) Because the target disease occurs in both men and women.
(3) Because most patients with the target disease are outpatients.
(4) To comply with the spirit of the Declaration of Helsinki
(5) To exclude patients with remaining minority teeth because periodontal disease patients are targeted.
(6) To target patients with poor plaque control.

Exclusion Criteria
Patients with any one of the following conditions will be excluded.
(1) Patients with uncontrolled diabetes mellitus
(2) Patients receiving antibacterial or anti-inflammatory drugs
(3) Other patients who are deemed inappropriate as research subjects by the principal investigator.

Reasons for setting up the study
(1) Diabetes mellitus may be related to the pathogenesis of periodontal disease.
(2) To exclude the influence of medications
(3) To exclude ineligible patients for the proper conduct of the study.

Participant flow

The study will follow a schedule of tooth brushing instruction, examination and information collection. Tooth brushing instruction will be conducted after PCR recording and intraoral photographs will be taken before and after tooth brushing instruction.

Adverse events

n.p.

Outcome measures

(Primary endpoint)
Difference in PCR values
(between visits 1-2, 2-3, and 1-3, evaluated by mode and brush)

(Secondary endpoint)
Difference in success or failure in achieving a PCR value of less than 20%.
Difference in the presence or absence of bleeding during probing, improvement of periodontal pockets, and improvement of gross findings
(evaluated by mode and brush)

Safety endpoints
Gingival injury during electric toothbrush use at the time of visit

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2019

Year

09

Month

09

Day

Date of IRB

2019

Year

10

Month

21

Day

Anticipated trial start date

2019

Year

10

Month

21

Day

Last follow-up date

2019

Year

12

Month

31

Day

Date of closure to data entry

2019

Year

12

Month

31

Day

Date trial data considered complete

2019

Year

12

Month

31

Day

Date analysis concluded

2020

Year

12

Month

31

Day

Other related information

Registered date

2019

Year

10

Month

03

Day

Last modified on

2023

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043539