UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047332 |
|---|---|
| Receipt number | R000053969 |
| Scientific Title | Prevention of biofilm adhesion with oral appliance coating for implant bridges |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/04/23 12:42:26 |
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Basic information
Public title
Prevention of biofilm adhesion with oral appliance coating for implant bridges
Acronym
Prevention of biofilm adhesion with oral appliance coating for implant bridges
Scientific Title
Prevention of biofilm adhesion with oral appliance coating for implant bridges
Scientific Title:Acronym
Prevention of biofilm adhesion with oral appliance coating for implant bridges
Region
| Japan |
Condition
Condition
Dental implant treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cleaning the mucosal surface of an implant bridge is difficult, and adhered plaque with aggregated bacteria forms.
The purpose of this study was to apply recently developed intraoral appliance coating materials for preventing bacterial adhesion to dentures to implant bridges and to verify them bacteriologically.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial counts on mucosal surfaces of implant bridges before and after coating
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intervention:bacterial count(+),,coating treatment(+)
Interventions/Control_2
Control:bacterial count(-),coating treatment(-)
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient have a full-mouth implant bridge with screw retainers of resin mucosal surface material
Key exclusion criteria
Patients with (1)bridges whose mucosal surface material is other than resin,and(2)fixed bridges,(3)dementia who have difficulty performing self-care,(4)not receiving regular maintenace treatment,(5)receiving medications such as antimicrobial agents for systemic diseases within 3 months(6),did not consent to this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Arai |
Organization
Niigata University Medical&Dental Hospital
Division name
Temporomandibular Joint & Dental implant Clinic
Zip code
9518520
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, 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&Dental Hospital
Division name
Temporomandibular Joint & Dental implant Clinic
Zip code
9518520
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata
TEL
0252272975
Homepage URL
ara@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Committee for Research Involving Human Subjects
Address
5274 1-Bancho, Gakkocho-dori, 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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Patient underwent implant surgery at Niigata University Medical and Dental Hospital and was fixed with a screw-retained full mouth implant bridge with resin mucosa surface material
Participant flow
Patients with ongoing maintenance follow ups who gave consent for this study
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053969
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
