UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018586
Receipt number R000021512
Scientific Title Randomized controlled trial on efficacy of non-metal clasp dentures
Date of disclosure of the study information 2015/09/01
Last modified on 2023/08/14 12:06:45

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Basic information

Public title

Randomized controlled trial on efficacy of non-metal clasp dentures

Acronym

Randomized controlled trial of non-metal clasp dentures

Scientific Title

Randomized controlled trial on efficacy of non-metal clasp dentures

Scientific Title:Acronym

Randomized controlled trial of non-metal clasp dentures

Region

Japan


Condition

Condition

Missing teeth

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify efficacy of non-metal clasp dentures

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Oral Health-related Quality of Life

Questionnaire: Oral-health impact profile (OHIP)-J (54 items)
Evaluation interval: pre-treatment,
3, 6, 12, 24 and 36 month after treatment

Key secondary outcomes

Patient satisfaction
Masticatory function
Periodontal condition


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Metal clasp denture

Interventions/Control_2

Non-metal clasp denture

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

- Patients who are planned to receive prosthetic treatment with definitive clasp-retained removable partial dentures
- Clasps will be fabricated on anterior and/or premolar teeth
- Absence of caries on all abutment teeth
- Mobility less than 2, periodontal pocket depth less than 4 mm and absence of bleeding on probing on all abutment teeth

Key exclusion criteria

- Contra-indications for non-metal clasp dentures
-Metal full cast fixed denture is fabricated on abutment on which resin clasp will be placed
- Patients who cannot accept to use metal clasp dentures due to esthetic reason
- Patients with metal, accrylic resin, peanuts allergy

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Fueki

Organization

Tokyo Medical and Dental University

Division name

Graduate school, Removable partial denture prosthodontics

Zip code

1130034

Address

1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan

TEL

03-5803-5514

Email

kunfu.rpro@tmd.ac.jp


Public contact

Name of contact person

1st name Fueki
Middle name
Last name Kenji

Organization

Tokyo Medical and Dental University

Division name

Graduate school, Removable partial denture prosthodontics

Zip code

1130034

Address

1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan

TEL

03-5803-5744

Homepage URL


Email

kunfu.rpro@tmd.ac.jp


Sponsor or person

Institute

Kenji Fueki

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


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 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan

Tel

03-5803-5404

Email

d-hyoka.adm@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病院(東京都)Tokyo Medical and dental University Hospital Faculty of Dentistry


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 01 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

10

Results


Results date posted


Results Delayed


Results Delay Reason


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

Completed

Date of protocol fixation

2015 Year 08 Month 31 Day

Date of IRB

2015 Year 08 Month 07 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 07 Day

Last modified on

2023 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name