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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007740
Receipt No. R000009108
Scientific Title A clinical research to evaluate the performance of Straumann Tissue Level Implants with SLA surface in Single Tooth Gaps in the pre-molar and molar region
Date of disclosure of the study information 2012/04/13
Last modified on 2014/07/08

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Basic information
Public title A clinical research to evaluate the performance of Straumann Tissue Level Implants with SLA surface in Single Tooth Gaps in the pre-molar and molar region
Acronym A clinical research of SLA/TL implant
Scientific Title A clinical research to evaluate the performance of Straumann Tissue Level Implants with SLA surface in Single Tooth Gaps in the pre-molar and molar region
Scientific Title:Acronym A clinical research of SLA/TL implant
Region
Japan

Condition
Condition Single Tooth Gaps in the pre-molar and molar region
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate SLA/TL Implant in a conventional loading procedure based on crestal bone level change measured at surgery and 6 months after surgery with Japanese subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the crestal bone level change at the implant site (mean of mesial and distal measurements) in conventional loading procedures measured at 6 months (+/- 2 weeks) post implant placement.
Key secondary outcomes 1.Evaluation of survival rate and Buser's success criteria of individual implants
2.Evaluation of crestal bone level change at 12months(+/-4 weeks) post surgery compared to base line (surgery)

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 Standerdized X-ray
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 must have voluntarily signed the informed consent form before any research related action.
2.Males and females with at least 20 years of age.
3.Single tooth gaps in molar or premolar in the mandible or maxilla
4.Adequate oral hygiene level
5.Bone quality I-III and quantity at the implant site to permit the insertion of the SLA/TL Implant.
6.Substantially healed extraction sockets
Key exclusion criteria Systemic exclusion criteria
1. Patients with the systemic disease that would interfere with dental implant therapy
2. Patients with the disease which are applicable to any contraindications or principle contraindications for oral surgery procedures.
3. Patients who smoke >10 cigarettes per day.
4. Patients who have participated in another clinical research within 30 days before obtaining the consent for participating in this research, or who expect to participate in any other investigational drug or device research during the conduct of this research.
5. Patients who can not follow the instruction from principal investigator or investigator.
6. Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of research participation or interfere with analysis of research results.
7. Pregnant or breastfeeding women, and women who desire to get pregnant during clinical research or who has a possibility of it.
8. Patients who are uncooperative.
Dental Exclusion Criteria
1. Any untreated dental and serious periodontal lesions
2. Severe bruxing or clenching habits
3. Existing implants in the adjacent position
4. Removable dentures or un-restored tooth gaps in the opposing dentition
5. Insufficient oral-hihygiene or patients unmotivated for adequate home care
6. Probing pocket depth of &#8805; 4 mm on one of the teeth immediately adjacent to the dental implant site
7. Major simultaneous augmentation procedures.
8. Patients who need a maxillary sinus lift, socket preservation, or ridge augmentation prior to implant placement.
9. Patients who received another implant placement that resulted in failure on the planned site of implant.

Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Shiota
Organization Tokyo Medical and Dental University
Division name Oral Implantology & Regenerative Dental Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Shiota
Organization Tokyo Medical and Dental University
Division name Oral Implantology & Regenerative Dental Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Straumann Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 東京医科歯科大学歯学部附属病院(東京都)
東京歯科大学千葉病院(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 13 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 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 01 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 03 Day
Date trial data considered complete
2014 Year 03 Month 06 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 13 Day
Last modified on
2014 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009108

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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