UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011511 |
|---|---|
| Receipt number | R000013467 |
| Scientific Title | Clinical evaluation of a novel device for the treatment of periodontitis by applying a photolysis of hydrogen peroxide disinfection technique |
| Date of disclosure of the study information | 2013/08/23 |
| Last modified on | 2016/08/05 14:55:50 |
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Basic information
Public title
Clinical evaluation of a novel device for the treatment of periodontitis by applying a photolysis of hydrogen peroxide disinfection technique
Acronym
A new disinfection device for the treatment of periodontitis
Scientific Title
Clinical evaluation of a novel device for the treatment of periodontitis by applying a photolysis of hydrogen peroxide disinfection technique
Scientific Title:Acronym
A new disinfection device for the treatment of periodontitis
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to verify the safety and the efficacy of a novel device for the treatmet of periodontal disease by applying photolysis of hydrogen peroxide disinfection technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Probing pocket depth
Key secondary outcomes
Bacteriological examination, Gingival index, Plaque index, Clinical attachment level, Bleeding on probing, Gingival resession
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Root debridement using the novel device
Interventions/Control_2
Root debridement using the conventional ultrasound scaler
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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who suffer from generalized chronic periodontitis with 8 or more teeth which have >=6mm periodontal pocket and show positive of bleeding on plobing.
Patients who have 18 or more remaining teeth.
Patients who is systematically healthy.
Key exclusion criteria
Smoker
Pregnant female
Patients who have had antibiotics within the last 6 months.
Patients who have had the periodontal treatment with the subgingival aria within the last 12 months.
Patients who uses a medicine to affect for the clinical sign of periodontal disease.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Shimauchi |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Periodontology and Endodontology
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8363
simauti@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Kanno |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Fixed Prosthodontics
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8363
Homepage URL
tarou@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2013 | Year | 08 | Month | 23 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 02 | 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
| 2013 | Year | 08 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013467
