UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038654
Receipt No. 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 (Ver. 7)

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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
Email 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
Email takashima@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044042