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Recruitment status Completed
Unique ID issued by UMIN UMIN000013376
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email moro@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015601


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