![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034097 |
Receipt No. | R000038853 |
Scientific Title | Study on preventive effect of mouth wash against mucosa around the dental implant. |
Date of disclosure of the study information | 2018/09/12 |
Last modified on | 2018/09/12 |
Basic information | ||
Public title | Study on preventive effect of mouth wash against mucosa around the dental implant. | |
Acronym | Study on preventive effect of mouth wash against mucosa around the dental implant. | |
Scientific Title | Study on preventive effect of mouth wash against mucosa around the dental implant. | |
Scientific Title:Acronym | Study on preventive effect of mouth wash against mucosa around the dental implant. | |
Region |
|
Condition | ||
Condition | Peri-implant mucositis, Peri-implantitis | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The clinical findings of the implant around the longitudinal used mouthwashes investigated in implant patients, to elucidate the efficacy of mouthwashes combination of self-care.
|
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Others |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | gingival index |
Key secondary outcomes | pocket probing depth, bleeding on probing, plaqe index |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 4 | |
Purpose of intervention | Prevention | |
Type of intervention |
|
|
Interventions/Control_1 | Tap water
Intervention period: 1 month ervention amount: 1 times 100mL times: twice daily |
|
Interventions/Control_2 | Cetylpyridinium chloride hydrate
Intervention period: 1 month Intervention amount: 1 times 100mL times: twice daily |
|
Interventions/Control_3 | Chlorhexidine gluconate
Intervention period: 1 month Intervention amount: 1 times 25-50mL times: twice daily |
|
Interventions/Control_4 | Povidone-iodine
Intervention period: 1 month Intervention amount: 1 times 60mL times: twice daily |
|
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Implant treatment has been completed.
Age is a full 20 years of age or older at the time of obtaining informed consent. Patients written consent was obtained. |
|||
Key exclusion criteria | Not subjected to implant treatment.
Hypersensitivity to mouthwash. It determined that the other researcher is not suitable as research subjects. |
|||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Kyushu University Hospital | ||||||
Division name | Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 092-642-6441 | ||||||
koyano@dent.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Kyushu University Hospital | ||||||
Division name | Department of Medical Technology | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 092-642-6441 | ||||||
Homepage URL | |||||||
chika-dh@med.kyushu-u.ac.jp |
Sponsor | |
Institute | Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University |
Institute | |
Department |
Funding Source | |
Organization | nothing |
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 | |
Address | |
Tel | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038853 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |