UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039716 |
|---|---|
| Receipt number | R000045176 |
| Scientific Title | Effect of professional mechanical tooth-cleaning by dental hygienist before implant surgery on transient bacteremia |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2022/02/15 13:48:54 |
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Basic information
Public title
Effect of professional mechanical tooth-cleaning by dental hygienist before implant surgery on transient bacteremia
Acronym
Effect of professional mechanical tooth-cleaning by dental hygienist before implant surgery on transient bacteremia
Scientific Title
Effect of professional mechanical tooth-cleaning by dental hygienist before implant surgery on transient bacteremia
Scientific Title:Acronym
Effect of professional mechanical tooth-cleaning by dental hygienist before implant surgery on transient bacteremia
Region
| Japan |
Condition
Condition
Dental implant treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of professional mechanical tooth-cleaning by dental hygienist before implant surgery on transient bacteremia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of transient bacteremia
Key secondary outcomes
Bacterial counts
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group:Oral bacterial count(+),PMTC(+)
Interventions/Control_2
Control group:Oral bacterial count,PMTC(-)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Age over 18 years old
(2)Unilateral partial edentulous patients who have 4 missing teeth or less. Those patients are placed 1-2 implants.
(3) Low-risk patients who do not need prophylactic antibiotics
Key exclusion criteria
Patients with(1) no basic periodontal treatment, and (2) receiving medications such as antimicrobial agents for systemic diseases within 3 months.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Arai |
Organization
Niigata University Medical and Dental Hospital
Division name
Temporomandibular Joint Clinic
Zip code
951-8520
Address
754, Asahimachi-1, Chuou-ku, Niigata city, Niigata
TEL
0252272975
ara@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Arai |
Organization
Niigata University Medical and Dental Hospital
Division name
Temporomandibular Joint Clinic
Zip code
9518520
Address
754, Asahimachi-1, Chuou-ku, Niigata city, Niigata
TEL
0252272975
Homepage URL
ara@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutiona Review Board of the Niigata University
Address
2-5274 Gakkomachi, Chuo-ku, Niigata
Tel
0252272975
ara@dent.niigata-u.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 | 03 | Month | 05 | 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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045176
