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

Email



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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name