UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Toshiyuki Sasaguri
Organization	Facluty of Medical Sciences, Kyushu Univ
Division name	Clinical Pharmacology
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	Fumi Takahashi
Organization	Facluty of Medical Sciences, Kyushu Univ
Division name	Clinical Pharmacology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010335