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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008795
Receipt No. 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

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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
Email 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
Email yanaga@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010335

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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