UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013353 |
|---|---|
| Receipt number | R000015338 |
| Scientific Title | Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps |
| Date of disclosure of the study information | 2014/03/06 |
| Last modified on | 2014/03/06 15:38:36 |
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Basic information
Public title
Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps
Acronym
Clinical trial study of modSLA Implant
Scientific Title
Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps
Scientific Title:Acronym
Clinical trial study of modSLA Implant
Region
| Japan |
Condition
Condition
Patients with the single tooth loss in molar or premolar in the maxilla or mandible who are candidate for the dental implantation
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate non-inferiority of the modSLA implant in an early loading procedure (healing period: 25+/-3 days)compared to a conventional loading procedure (healing period: 12-14 weeks) based on crestal bone level change measured at surgery and 6 months(+/-2 weeks) after surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Crestal bone level change at the implant site (mean of mesial and distal measurements) in early and conventional loading procedures measured at 6 months (+/-2 weeks) post implant placement
Key secondary outcomes
1. Evaluation of survival and success rates of indivisual implants
2. Evaluation of crestal bone level change at 12 months ((+/-4 weeks) post-surgery compared to baseline (surgery)
3. Evaluation of patient satisfaction
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional loading
Interventions/Control_2
Early loading
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.Subjects must have voluntarily signed the informed consent form before any study 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 modSLA Implant
6.Substantially healed (at least 16 weeks after tooth extraction) extraction sockets
Key exclusion criteria
Systemic exclusion criteria
1. Patients with the systemic disease that would interfere with dental implant therapy (Blood poisoning, weakened immune system, diabetes mellitus, etc--)
2. Patients with the following disease which are applicable to any contraindi-cations or principle contraindications for oral surgery procedures
2-1. Patients who are suffering from a serious internal medical problem such as cardiac infraction or cerebral infraction, uncontrollable endo-crine disorders
2-2. Patients who are suffering from a metabolic bone disease, tem-poromandibular joint disorders, maxillary and mandibular growth not completed, treatable changes in the oral mucosa, local root remnants, xerostomia, patients on bisphosphonate medication
2-3. Patients who are suffering from an inadequate wound healing ca-pacity, prolonged therapy-resistant functional disorders, illnesses re-quiring periodic use of steroids, and who has an irradiation history
2-4. Patients who are having an uncontrolled bleeding disorders, antico-agulation drugs/hemorrhagic diatheses
2-5. Patients who are suffering from psychoses, drug or alcohol abuse, titanium allergy
3. Patients who smoke >10 cigarettes per day
4. Subjects who have participated in another clinical trial within 30 days be-fore obtaining the consent for participating in this trial, or who expect to participate in any other investigational drug or device study during the conduct of this trial
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 study participation or interfere with analysis of study results
7.Pregnant or breastfeeding women, and women who desire to get preg-nant during clinical study or who has a possibility of it
8.Patients who are uncooperative
Target sample size
74
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 Health Sciences Implant/Masticatory Function Rehabilitation
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
03-5803-5774
mshiota.impl@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eisaku WATANABE |
Organization
Straumann Japan K.K.
Division name
Regulatory&Comliance Clinical Reseach
Zip code
Address
Sapia Tower 16F,1-7-12 Marunouchi,Chiyoda-KU, Tokyo 100-0005, Japan
TEL
03-5218-2613
Homepage URL
eisaku.watanabe@straumann.com
Sponsor or person
Institute
Straumann Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Straumann Japan K.K.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2014 | Year | 03 | Month | 06 | 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
| 2010 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2014 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015338
