UMIN-CTR Clinical Trial

Basic information
Public title	Application of Er:YAG laser in the treatment of periodontal pockets with intrabony defects
Acronym	Er:YAG laser treatment of periodontal pockets
Scientific Title	Application of Er:YAG laser in the treatment of periodontal pockets with intrabony defects
Scientific Title:Acronym	Er:YAG laser treatment of periodontal pockets
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of combination therapy of SRP and Er:YAG laser treatment in periodotal pockets with intrabony defects compared to SRP alone by randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical Attachment Level (CAL) at 1 and 2 weeks and 1, 3 , 6 and 12 months after treatment.
Key secondary outcomes	Proving pocket depth (PPD), Gingival recession, tooth mobility, Bleeding on Probing (BOP), Plaque Index(PI), Gingival Index (GI), total number of periodontal bacteria (P.gingivalis, T. forsythia, T. denticola) and IL-1b level in gingival crevicular fluid at 1 and 2 weeks and 1, 3, 6 and 12 months after treatment. Evaluation of discomfort and pain by Visual Analog Scale (VAS) method up to 4 weeks after treatment. Evaluation of X-ray after 6 and 12 months after treatment.

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	Device,equipment Maneuver
Interventions/Control_1	Following SRP, Er:YAG laser irradiation is performed with water spray at 30 Hz and 50-80 mJ at panel setting.
Interventions/Control_2	SRP
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The patient who is receiving periodontal therapy in Dental Hospital of Tokyo Medical and Dental University 2. Single rooted tooth with attachment loss, pocket depth of 5 mm or more, BOP (+), tooth mobility class I or less and bone defect depth of 3 mm or more 3. Based on the split mouth design, there are 1 or more teeth that meet the above conditions in 2 quadrants of the mouth.
Key exclusion criteria	1. Having systemic disease that can affect periodontal condition, such as diabetes 2. Smokers 3. In case of pregnancy or lactation 4. The history of anesthesia allergy 5. Receiving antimicrobial agent in the last 3 months 6. Having an infectious disease, such as hepatitis or HIV
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Aoki
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology, Graduate School of Medical and Dental Sciences
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5488
Email	aoperi@tmd.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Aoki
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology, Graduate School of Medical and Dental Sciences
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5488
Homepage URL
Email	aoperi@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental School
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	Yushima1-5-45, Bunkyo-ku, Tokyo
Tel	03-5803-4523
Email	d-hyoka.adm@tmd.ac.jp

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	東京医科歯科大学歯学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 16 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	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 13 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	2018 Year 03 Month 08 Day
Last modified on	2021 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035827