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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name