UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027746 |
|---|---|
| Receipt number | R000031790 |
| Scientific Title | Effective assessmentg of a-PDT for periodontitis and peri-implantitis |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2019/06/02 09:40:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effective assessmentg of a-PDT for periodontitis and peri-implantitis
Acronym
Effect of a-PDT for periodontitis and peri-implantitis
Scientific Title
Effective assessmentg of a-PDT for periodontitis and peri-implantitis
Scientific Title:Acronym
Effect of a-PDT for periodontitis and peri-implantitis
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether a-PDT is effective for periodontitis including peri-implantitis ornot.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
presence or absence of inflammation 3 months after treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient who have a-PDT for periodontitis including peri-implantitis.
any age and any sex.
Key exclusion criteria
photo-sensiotive
pregnant
uncontrolled DM
severe sehatic and kidney disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Division of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
sohba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Division of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
Homepage URL
sohba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7704
sohba@nagasaki-u.ac.jp
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
| 2017 | Year | 06 | Month | 14 | 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
implantitis was not controlled by a-PDT when the pocket was deep.
pus discharge was decreased temporally.
periodontitis with shallow pocket was controlled by a-PDT.
There is a limitation to treat implantitis by a-PDT solely.
The effect of a-PDT may enhance with abrasion.
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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Stop the exam.
Management information
Registered date
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031790
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
