UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042426 |
|---|---|
| Receipt number | 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 | 2021/05/14 09:05:17 |
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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
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
yuusuke@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048420
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| Registered date | File name |
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