UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008795 |
|---|---|
| Receipt number | R000010335 |
| Scientific Title | Dose escalation trial to evaluate the safety and the efficacy on new bone formation of a single local treatment with lithium carbonate to teeth extraction sockets for dental implant in Japanese participants |
| Date of disclosure of the study information | 2012/08/29 |
| Last modified on | 2018/03/05 15:11:59 |
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Basic information
Public title
Dose escalation trial to evaluate the safety and the efficacy on new bone formation of a single local treatment with lithium carbonate to teeth extraction sockets for dental implant in Japanese participants
Acronym
Dose escalation trial to evaluate the safety and the efficacy on new bone formation of a single local treatment with lithium carbonate
Scientific Title
Dose escalation trial to evaluate the safety and the efficacy on new bone formation of a single local treatment with lithium carbonate to teeth extraction sockets for dental implant in Japanese participants
Scientific Title:Acronym
Dose escalation trial to evaluate the safety and the efficacy on new bone formation of a single local treatment with lithium carbonate
Region
| Japan |
Condition
Condition
dental implant
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of local lithium carbonate treatment will be evaluated by single administration to teeth extraction sockets for dental implant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the safety of the local treatment with lithium carbonate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Local treatment with lithium carbonate
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese (<20 years, < 70 years old) who will be extracted molar and placed implant at Implant Center in Kyushu University Hospital
Key exclusion criteria
1 Person who is diagnosed as osteoporosis
2 Person who is suffered from bone disease
3 Person who is not allowed the treatment with lithium carbonate
4 Person who is treated with the medicine which may cause drug interaction with lithium carbonate
5 Body weight<40 kg, >90 kg
6 Person who has a periapical lesion in object tooth
7 Person who has 1- or 2-wall infrabony defects after object tooth extraction
8 Person judged as inappropriate by research contact person
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sasaguri |
Organization
Facluty of Medical Sciences, Kyushu Univ
Division name
Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6080
sasaguri@clipharm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumi Takahashi |
Organization
Facluty of Medical Sciences, Kyushu Univ
Division name
Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6082
Homepage URL
yanaga@clipharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept. of Clinical Pharmacology,Facluty of Medical Sciences, Kyushu Univ
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | 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
| 2012 | Year | 08 | Month | 29 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010335
