UMIN-CTR Clinical Trial

Basic information
Public title	Examination of suppression of periodontal pathogenic bacteria in the superstructure of dental implants coated with nano-silver particles and its effect of suppressing bad breath
Acronym	Examination of the effect of suppressing bad breath of dental implants coated with nano-silver particles
Scientific Title	Examination of suppression of periodontal pathogenic bacteria in the superstructure of dental implants coated with nano-silver particles and its effect of suppressing bad breath
Scientific Title:Acronym	Examination of the effect of suppressing bad breath of dental implants coated with nano-silver particles
Region	Japan

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

Objectives
Narrative objectives1	By applying nano-silver particles to the superstructure of a dental implant, how much the nano-silver particles show the bacteriostatic effect of periodontal disease-causing bacteria in the tissue surrounding the implant, and the bacteriostatic effect of the periodontal disease-causing bacteria due to it. The purpose of this study is to investigate how much the effect of suppressing bad breath is and how long it lasts.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Gingival inflammation index (Modified Gingival Index) 3), (2) mPI (modified plaque index) & mBI (modified sulcus bleeding index) 4), (3) Sensory test and gas chromometry around the abutment (Measure the odor), (4) Observe the periodontal disease bacteria and the total number of bacteria (quantitative PCR analysis) around the abutment. Both groups should brush their teeth at least twice a day. In this experiment, we will investigate the bacteriostatic properties of nano-silver particles applied to the superstructure.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	At the Department of Oral Implants, our university hospital, 10 patients who have been treated with one or more implants for the upper and lower jaw tooth defects and who do not have silver allergy are targeted.
Key exclusion criteria	Systemic exclusion criteria Under 20 years old Patients with silver allergies Patients with uncontrolled systemic disease. Patients with mental illness who cannot communicate. Patients with alcohol / drug addiction. Patients who are uncooperative with treatment.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kido Middle name Last name Hirofumi
Organization	Fukuoka Dental College
Division name	Oral Rehabilitation Oral Implantology
Zip code	814-0193
Address	2-15-1 Tamura,Sawara-ku,Fukuoka
TEL	092-801-0411
Email	hkido@college.fdcnet.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Taniguchi
Organization	Fukuoka Dental College
Division name	Oral Rehabilitation Oral Implantology
Zip code	814-0193
Address	2-15-1 Tamura,Sawara-ku,Fukuoka
TEL	092-801-0411
Homepage URL
Email	yuusuke@college.fdcnet.ac.jp

Sponsor
Institute	Fukuoka Dental College
Institute
Department

Funding Source
Organization	Fukuoka Dental College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuoka Dental College
Address	2-15-1 Tamura,Sawara-ku,Fukuoka
Tel	092-801-0411
Email	yuusuke@college.fdcnet.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

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 22 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	2020 Year 11 Month 22 Day
Date of IRB	2020 Year 09 Month 16 Day
Anticipated trial start date	2020 Year 11 Month 22 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The subjects were divided into a group in which silver ions were applied to the Ti abutment and a group in which nothing was applied to the Ti abutment. Index) 3), mPI (modified plaque index) & mBI (modified sulcus bleeding index) 4), Sensory test around the abutment and gas chromometry (remove the abutment and put it in a microtube to measure the odor of the head space), (4) Observe the periodontal disease bacteria around the abutment and the total number of bacteria (quantitative PCR analysis). Both groups should brush their teeth at least twice a day. In this experiment, we will investigate the bacteriostatic properties of nano-silver particles applied to the superstructure.

Management information
Registered date	2020 Year 11 Month 12 Day
Last modified on	2021 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048420