UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007637
Receipt number R000008838
Scientific Title Chronological changes in the stability and marginal bone level of immediately loaded NobelActive implants using NobelGuide for edentulous maxilla: one-year prospective clinical study
Date of disclosure of the study information 2012/04/01
Last modified on 2014/04/01 11:07:39

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Basic information

Public title

Chronological changes in the stability and marginal bone level of immediately loaded NobelActive implants using NobelGuide for edentulous maxilla: one-year prospective clinical study

Acronym

Chronological changes in the stability and marginal bone level of immediately loaded Implants for edentulous maxilla

Scientific Title

Chronological changes in the stability and marginal bone level of immediately loaded NobelActive implants using NobelGuide for edentulous maxilla: one-year prospective clinical study

Scientific Title:Acronym

Chronological changes in the stability and marginal bone level of immediately loaded Implants for edentulous maxilla

Region

Japan


Condition

Condition

Edentulous maxilla

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of effectiveness, factors for treatment success, and patient satisfaction in immediately loaded NobelActive Implants using NobelGuide for edentulous maxilla.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Chronological change of implant stability
2.Chronological change of marginal bone level
3.Factors affecting stability and marginal bone level
4. Evaluation of patient satisfaction

Key secondary outcomes

1. Chronological change of occlusal force
2.Correlation between marginal bone level and PPD,BOP,PI
3. Relationship between insertion torque and ISQ


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Placement of NobelActive implants using NobelGuide for edentulous maxilla and application of immediate Load

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

1) Patients older than 20 years agreed to participate in this study
2) Edentulous maxilla(More than three months After extraction)
3) Four or more implants can be inserted into the maxilla

Key exclusion criteria

1) Systemic disease that would interfere
with dental implant therapy
(e.g.uncontrolled diabetes)
2) Any contraindications for oral surgical
procedures
1.Are taking medications that interfere with treatment (Bisphosphonate drugs ,Steroid , Anticoagulant etc.)
2.Leukocyte dysfunction or deficiency
3.Unmanageable bleeding disorders
4.Neoplastic disease that require Radiotherapy and Chemotherapy
5.Immunodeficiency and Immunological deterioration
6.Patients with metabolic bone disease
7.Poor oral hygiene , Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
8.Severe periodontitis
9.Mucosal diseases (e.g. erosive lichen planus and Erosive leukoplakia)
10.History of local irradiation therapy in the head / neck area
11.Drug dependence and Alcoholism
12.Dysfunction of wound healing
13.Patients who have not completed bone growth
14.Xerostomia
15.Titanium allergy
16.Unmanageable Endocrine disease
3)Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
4)Pregnant or breastfeeding women
5) Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
6)Bone augmentation has been applied for the implant insertion site

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Yamada

Organization

Fukuoka Tenjin Implant Clinic

Division name

Fukuoka Tenjin Implant Clinic

Zip code


Address

1-9-17 Tenjin, Chuo-ku, Fukuoka Fukuoka Tenjin Fukoku Life Building 9F

TEL

092-738-4618

Email

ymd1966@dent.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Yamada

Organization

Fukuoka Tenjin Implant Clinic

Division name

Fukuoka Tenjin Implant Clinic

Zip code


Address

1-9-17 Tenjin, Chuo-ku, Fukuoka Fukuoka Tenjin Fukoku Life Building 9F

TEL

092-738-4618

Homepage URL


Email

ymd1966@dent.kyushu-u.ac.jp


Sponsor or person

Institute

Section of Implant and Rehabilitative Dentistry,
Division of Oral Rehabilitation,
Kyushu University Faculty of Dental Science

Institute

Department

Personal name



Funding Source

Organization

Nobel Biocare

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

SWITZERLAND


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2012 Year 04 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

Completed

Date of protocol fixation

2011 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 01 Day

Last modified on

2014 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008838


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name