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
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
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
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
