UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biological and clinical effect of antimicrobial photo dynamic therapy and local drug delivery system for chronic periodontitis: a randomized controlled clinical trial
Title of the study (Brief title)	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	Hiromasa Yoshie
Organization	Niigata University
Division name	Graduate School of Medical and Dental Sciences
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	Toshiya Morozumi
Organization	Niigata University
Division name	Medical & Dental Hospital
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015601