UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038654 |
|---|---|
| Receipt number | R000044042 |
| Scientific Title | Study of bacterial count on the effect of professional mechanical plaque removal at the implant bridge |
| Date of disclosure of the study information | 2019/11/21 |
| Last modified on | 2020/03/11 20:00:29 |
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Basic information
Public title
Study of bacterial count on the effect of professional mechanical plaque removal at the implant bridge
Acronym
Study of bacterial count on the effect of professional mechanical plaque removal at the implant bridge
Scientific Title
Study of bacterial count on the effect of professional mechanical plaque removal at the implant bridge
Scientific Title:Acronym
Study of bacterial count on the effect of professional mechanical plaque removal at the implant bridge
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 determine whether removing the superstructure of the implant bridge in cases of full-arch implant restorations for edentulous atrophic arches at the abutment level during professional mechanical plaque removal (PMPR) affects bacterial counts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial counts
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Evaluate the bacterial counts after professional mechanical plaque removal treatment with removal of the superstructure.
Interventions/Control_2
Evaluate the bacterial counts after professional mechanical plaque removal treatment without removal of the superstructure.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Regular-checkup patients who had lost eight or more teeth were treated with implant bridges
(2)Patients treated with screw-retained fixed prostheses using Nobel Biocare multi-unit abutments.
(3) More than 6 months had passed since prostheses were fixed
Key exclusion criteria
Patients with (1)symptoms of infection in the oral cavity including the peri implantitis and (2) those receiving medications such as antimicrobial agents for systemic diseases
Target sample size
20
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 | Makiko |
| Middle name | |
| Last name | Takashima |
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
takashima@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
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
| 2019 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044042
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044042
Number of participants that the trial has enrolled
20
Results
Among patients with bacterial counts of less than 10 x 100000 cfu/ml, bacterial loads were reduced to less than 1.0 x 100000 cfu/ml even when superstructures were not removed. Among patients with bacterial load of >10 x 100000 cfu/ml, bacterial numbers were not reduced to <1.0 x 100000 cfu/ml when PMPR was performed without removing the superstructure.
Results date posted
| 2019 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 23 patients were eligible for participation in this study. 3 were excluded according to the exclusion criteria and 20 were assigned into WR-WOR and WOR-WR groups of 10 patients each.
Participant flow
A summary of the research design is shown in Fig. 1. In this crossover study, patients were allocated alternately in a 1:1 ratio for PMPR treatments with (WR) and without (WOR) removal of the superstructure during period 1 followed by the opposite PMPR treatment during period 2. After a 3-month washout period, subjects were crossed over to receive the other treatment. All treatments were performed over the same time span.
Adverse events
nothing
Outcome measures
Bacterial counts around the cylinder and abutment were reduced significantly by PMPR in both WR and WOR groups, compared with before PMPR (p < 0.05)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 18 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044042
