UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis: a clinical randomized controlled trial.
Title of the study (Brief title)	Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis.
Region	Japan

Condition
Condition	Peri-implant mucositis and peri-implantitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical and microbiological effects and changes of cytokine expression levels by Er: YAG laser treatment for peri- implant mucositis and peri-implantitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cytokine expression levels in peri-implant crevicular fluid
Key secondary outcomes	Species and numbers of subgingival bacteria

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
Interventions/Control_1	Test group 1: 18patients 2: Er: YAG laser beam is delivered into the pocket of implant using PS600T tip at 30mJ/25pps under water irrigation.
Interventions/Control_2	Control group 1: 18 patients 2: 2% minocycline ointment is delivered into the pocket of implant.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Moderate to severe peri-implant mucositis and peri-implantitis. 2.Having probing pocket depth(PPD) equal or greater than 5mm and bleeding on probing(BOP) positive.
Key exclusion criteria	1.Persons who have acute inflammation of the tooth next to the candidate implant. 2.Persons who take systemic antibiotics or anti-inflammatory drugs within 3 months before experiment. 3.Persons who have severe systemic diseases. 4.Pregnancy in women. 5.Persons who have heart pacemaker or any other systemic conditions that might be affected byEr: YAG laser treatment.
Target sample size	36

Research contact person
Name of lead principal investigator	Hiromasa Yoshie
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Periodontology
Address	2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL	025-227-2871
Email	yoshie@dent.niigata-u.ac.jp

Public contact
Name of contact person	Yasutaka Komatsu
Organization	Niigata University Medical & Dental Hospital
Division name	Department of Periodontics
Address	1-754 Asahimachi-Dori, Chuo-ku, Niigata, 951-8520, Japan
TEL	025-227-2871
Homepage URL
Email	komatsu@dent.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	J. Morita Mfg. Corp, Kyoto, Japan.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1.Department of Periodontology, Faculty of Dentistry, Asahi University 2.Department of Periodontology, Osaka Dental University 3.Yamamoto Dental Office
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	新潟大学医歯学総合病院（新潟県） 朝日大学歯学部付属病院（岐阜県） 大阪歯科大学附属病院（大阪府） 山本歯科（大阪府）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 16 Day
Anticipated trial start date	2012 Year 09 Month 24 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 28 Day
Last modified on	2018 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010330