UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis: a randomized controlled clinical trial
Acronym	Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis
Scientific Title	Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis: a randomized controlled clinical trial
Scientific Title:Acronym	Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis
Region	Japan

Condition
Condition	Peri-implantitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate and compare the efficacy of regenerative surgical therapy for peri-implantitis between Er: YAG laser and mechanical debridement in terms of clinical, microbiological and biochemical aspects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of LPS level before and after the decontamination of affected implant surface.
Key secondary outcomes	Probing pocket depth Bone level Bacterial counts in subgingival plaque Biomarker level in peri-implant 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	Device,equipment
Interventions/Control_1	Test group (N=12) Decontamination of affected implant and debridement of granulation tissue around peri-implantitis are made using Er: YAG laser.
Interventions/Control_2	Control group (N=12) Decontamination of affected implant and debridement of granulation tissue around peri-implantitis are made using ultrasonic scaler and cotton pellet soaked in sterile saline.
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.Person who obtained written informed consent. 2.One study implant have at least 2 sites of probing pocket depth (PPD) greater than 5 mm with bleeding on probing (BOP) and more than 3 mm bone loss.
Key exclusion criteria	1.Persons who had received non-surgical peri-implant therapy within the previous 3 months 2.Persons who had received surgical peri-implant therapy within the previous 6 months 3.Persons who had taken systemic antibiotics or anti-inflammatory drugs within 3 months before experiment 4.Acute periodontal burden on the study implant and the adjacent natural tooth 5.Smoker 6.Persons who had severe systemic diseases 7.Persons who are pregnant or suspected to be pregnant 8.Pacemaker or any other systemic conditions that might be affected by the Er: YAG laser treatment 9.Persons who are judged to be unqualified for this study subjects by investigators.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Takehiko Middle name Last name Kubota
Organization	Niigata University
Division name	Graduate School of Medical and Dental Sciences
Zip code	951-8514
Address	2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL	025-227-2871
Email	kubota@dent.niigata-u.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Komatsu
Organization	Niigata University
Division name	Medical & Dental Hospital
Zip code	951-8514
Address	2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, 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
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	1. Department of Periodontology, Asahi University, School of Dentistry 2. Department of Periodontology, Osaka Dental University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics review board for clinical research, Niigata University
Address	2-8050, Ikarashi, Nishi-ku, Niigata, 950-2181, Japan
Tel	025-227-2625
Email	ethics@adm.niigata-u.ac.

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	2017 Year 02 Month 20 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	25
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	2015 Year 12 Month 10 Day
Date of IRB	2015 Year 05 Month 18 Day
Anticipated trial start date	2016 Year 01 Month 10 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 20 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030128