UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000866 |
|---|---|
| Receipt number | R000001042 |
| Scientific Title | Preliminary clinical study of a novel oral mucosal protective solution containing trehalose. –Alleviation of oral dryness caused during dental surgery– |
| Date of disclosure of the study information | 2007/10/29 |
| Last modified on | 2007/10/26 11:31:39 |
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Basic information
Public title
Preliminary clinical study of a novel oral mucosal protective solution containing trehalose. –Alleviation of oral dryness caused during dental surgery–
Acronym
Preliminary clinical study of a novel oral mucosal protective solution containing trehalose.
Scientific Title
Preliminary clinical study of a novel oral mucosal protective solution containing trehalose. –Alleviation of oral dryness caused during dental surgery–
Scientific Title:Acronym
Preliminary clinical study of a novel oral mucosal protective solution containing trehalose.
Region
| Japan |
Condition
Condition
Patients recieving root canal treatment
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the comfort level of the patients when 10% trehalose solution was sprayed during dental surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation of dryness, pain, discomfort by the patient and of tongue dryness and papilla atrophy by the doctor
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients recieving several root canal treatments will initially undergo the normal root canal treatment. In the next treatment, trehalose solution will be used.
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
1.Patients recieving several root canal treatments.
2.Patients willing and able to comply with the protocol and to give written informed consent .
3.Patients who have signed the IRB-approved written informed consent prior to the patient screening.
Key exclusion criteria
1. Patients who declared diabetes at the interview prior to the study and are judged to be ineligible by doctors.
2. Patients who need special care for safety in usual dental therapy and are judged to be ineligible by doctors.
3. Patients who are judged to be inappropriate for the study by doctors in their charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Takato |
Organization
The University of Tokyo Hospital
Division name
Department of Oral-Maxillofacial Surgery, Dentistry and Orthodontics
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-5800-8943
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Mori |
Organization
The University of Tokyo Hospital
Division name
Department of Oral-Maxillofacial Surgery, Dentistry and Orthodontics
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-5800-8669
Homepage URL
mori-ora@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Department of Oral-Maxillofacial Surgery, Dentistry and Orthodontics
Institute
Department
Personal name
Funding Source
Organization
Cellex K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2007 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 26 | Day |
Last modified on
| 2007 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001042
