UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013376 |
|---|---|
| Receipt number | R000015601 |
| Scientific Title | Biological and clinical effect of antimicrobial photo dynamic therapy and local drug delivery system for chronic periodontitis: a randomized controlled clinical trial |
| Date of disclosure of the study information | 2014/03/08 |
| Last modified on | 2018/03/11 09:02:44 |
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Basic information
Public title
Biological and clinical effect of antimicrobial photo dynamic therapy and local drug delivery system for chronic periodontitis: a randomized controlled clinical trial
Acronym
Biological and clinical effect of a-PDT and LDDS for chronic periodontitis
Scientific Title
Biological and clinical effect of antimicrobial photo dynamic therapy and local drug delivery system for chronic periodontitis: a randomized controlled clinical trial
Scientific Title:Acronym
Biological and clinical effect of a-PDT and LDDS for chronic periodontitis
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the microbiological, biochemical and clinical effects of antimicrobial photo dynamic therapy and local drug delivery system for chronic periodontitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of total bacteria and some periodontopathic bacteria in subgingival plaque
Key secondary outcomes
*Probing pocket depth
*Bleeding on probing
*Profile of bacterial flora in
subgingival plaque
*Biomarker level in gingival crevicular fluid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Test group
1. 15 patients
2. Two periodontal pockets are treated with a-PDT in twice at weekly intervals
Interventions/Control_2
Control group
1. 15 patients
2. Minocycline hydrochloride ointment are applied to 2 periodontal pockets in twice at weekly intervals
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 30 years or older persons who obtained written informed consent.
2. Slight to severe chronic periodontitis patients
3. Possessed a minimum of 20 teeth
4. Having at least 2 teeth with probing pocket depth (PPD) 5-8 mm in a full-mouth.
Key exclusion criteria
1. Persons who had received scaling and root planing within the previous 3 months
2. Persons who had taken systemic antibiotics or anti-inflammatory drugs within 3 months before experiment
3. Persons who had severe systemic diseases
4. Persons who is known or suspected hypersensitivity or intolerance to tetracyclines antibiotics, chlorhexidine and methylene blue.
5. Smoker
6. Persons who is suspected of having aggressive periodontitis
7. Persons who are pregnant or suspected to be pregnant.
8. Persons who have acatalasia, severe G6PD deficiency, Photosensitive epilepsy.
9. Persons who are judged to be unqualified for this study subjects by investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yoshie |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL
0252272871
yoshie@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Morozumi |
Organization
Niigata University
Division name
Medical & Dental Hospital
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL
0252272871
Homepage URL
moro@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Wavelengths Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yoshino Dental Clinic
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
| 2014 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 10 | 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
| 2014 | Year | 03 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015601
