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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044042


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name