UMIN-CTR Clinical Trial

Basic information
Public title	Can a maxillary implant overdenture work with two implants?
Acronym	Prospective clinical trial of maxillary 2-IOD
Scientific Title	Can a maxillary implant overdenture work with two implants?
Scientific Title:Acronym	Prospective clinical trial of maxillary 2-IOD
Region	Japan

Condition
Condition	edentulous
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct a prospective clinical study on 20 edentulous maxillary patients with 2-IOD using two implants and locator attachment as a maintenance source, and to clarify implant survival rate, peri-implant bone resorption, implant stability index, patient satisfaction, oral-related QoL and objective masticatory ability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Implant Survival Rate
Key secondary outcomes	Peri-implant bone resorption Implant Stability Index Patient Satisfaction Oral-related QoL Objective masticatory ability

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	2 - Implant Overdenture
Interventions/Control_2
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	Upper and lower jaw edentulou Able to answer the self-administered questionnaire General condition that allows implant surgery Maxillary crest: height (deepest part of the palate to the top of the crest): 10 mm or more, width 50 mm or more, length: 40 mm or more
Key exclusion criteria	Poorly controlled general condition History of BPS medication History of chemotherapy or radiation therapy to the head and neck region Heavy smoker Infectious disease Psychiatric disorders Temporomandibular joint disease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Kanazawa
Organization	Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Division name	Digital Dentistry
Zip code	1138549
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL	03-5803-5379
Email	m.kanazawa.gerd@tmd.ac.jp

Public contact
Name of contact person	1st name Maiko Middle name Last name Iwaki
Organization	Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Division name	Digital Dentistry
Zip code	1138549
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL	03-5803-5379
Homepage URL
Email	m.iwaki.gerd@tmd.ac.jp

Sponsor
Institute	Digital Dentistry, Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Institute
Department

Funding Source
Organization	Ministry of Education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
Tel	03-5803-5379
Email	m.kanazawa.gerd@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

Other administrative information
Date of disclosure of the study information	2021 Year 07 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
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	Preinitiation
Date of protocol fixation	2021 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2026 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	2021 Year 06 Month 30 Day
Last modified on	2021 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051065