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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042426
Receipt No. R000048420
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
Date of disclosure of the study information 2020/11/22
Last modified on 2020/11/12

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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 Preinitiation
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
2020 Year 11 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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