UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022753
Receipt number R000026176
Scientific Title Effect of dental treatment on metabolic syndrome: randomized controlled trial
Date of disclosure of the study information 2016/06/15
Last modified on 2022/06/15 10:22:47

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Basic information

Public title

Effect of dental treatment on metabolic syndrome: randomized controlled trial

Acronym

Metabolic syndrome and dental treatment

Scientific Title

Effect of dental treatment on metabolic syndrome: randomized controlled trial

Scientific Title:Acronym

Metabolic syndrome and dental treatment

Region

Japan


Condition

Condition

metabolic syndrome

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of the study is to determine the effect of dental treatment combined with diet therapy and exercise therapy on metabolic syndrome.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

abdominal circumference

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

dental treatment combined with dietary instruction and exercise instruction

Interventions/Control_2

dietary instruction and exercise instruction alone

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who are diagnosed as metabolic syndrome
patients who are classified with Eichner Index B1, B2,B3, B4, C1, C2, C3 or who has slight-to-moderate periodontal disease.
patients who are more then 40 years old.
patients who are informed about the nature of the study and provided written informed consent and give his/her written informed consent.

Key exclusion criteria

patients who have any dietary restriction
patients who have no means to implement dietary change, e.g., living in an institution.
patients who have serious heart disease
patients who have hypothyroidism or hyperthyroidis
patients who have severe liver impairment
patients who have severe kidney impairment
patients who are undergoing cancer therapy
patients who are pregnancy
patients who experienced significant amount of weight loss during the last 3 months
patients that the responsible person determined as ineligible

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yuriko
Middle name
Last name Komagamine

Organization

Tokyo Medical and Dental University

Division name

Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences

Zip code

113-8510

Address

Tokyo Medical and Dental University, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan

TEL

03-5803-5563

Email

y.komagamine.gerd@tmd.ac.jp


Public contact

Name of contact person

1st name Yuriko
Middle name
Last name Komagamine

Organization

Tokyo Medical and Dental University

Division name

Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences

Zip code

113-8510

Address

Tokyo Medical and Dental University, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan

TEL

03-5803-5563

Homepage URL


Email

y.komagamine.gerd@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-5404

Email

d-hyoka.adm@cmn.tmd.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京医科歯科大学歯学部附属大学病院


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

82

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Accepted, not published yet

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 06 Month 01 Day

Date of IRB

2019 Year 01 Month 25 Day

Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry

2019 Year 10 Month 01 Day

Date trial data considered complete

2019 Year 10 Month 01 Day

Date analysis concluded

2020 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 06 Month 15 Day

Last modified on

2022 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026176


Research Plan
Registered date File name
2017/06/26 MetS_実施計画書作成_20170227.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name