UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025813
Receipt number R000029568
Scientific Title The effects of Lactobacillus reuteri probiotics on peri-implantitis: a randomized placebo-controlled study
Date of disclosure of the study information 2017/01/26
Last modified on 2017/07/25 09:47:19

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Basic information

Public title

The effects of Lactobacillus reuteri probiotics on peri-implantitis: a randomized placebo-controlled study

Acronym

Probiotics for peri-implantitis patients

Scientific Title

The effects of Lactobacillus reuteri probiotics on peri-implantitis: a randomized placebo-controlled study

Scientific Title:Acronym

Probiotics for peri-implantitis patients

Region

Japan


Condition

Condition

peri-implantitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of a probiotic tablet containing L. reuteri in peri-implantitis patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

periodontal bacterial count (4wks, 12wks, 24wks after the intake of probiotics )

Key secondary outcomes

probing pocket depth, bleeding on probing, modified gingival index, modified plaque index at 4wks, 12wks, 24wks after the intake of probiotics


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Subject took one tablet containing L. reuteri probiotics a day for 6 months (intervention group)

Interventions/Control_2

Subject took one tablet non-containing L. reuteri probiotics a day for 6 months (control group)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

probing pocket depths are more than 4 mm and less than 7 mm
bleeding or suppuration on probing (+)
marginal bone loss > 2 mm

Key exclusion criteria

patients with uncontrolled systematic disease
patients who took antibiotics within 3 months
pregnant women
patients allergic to antibiotics

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuji Hosokawa

Organization

Kyushu Dental University

Division name

Department of Oral Reconstruction and Rehabilitation

Zip code


Address

2-6-1 Manazuru, Kokurakita, Kitakyushu, Fukuoka

TEL

093-285-3100

Email

hosokawa@kyu-dent.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chihiro Masaki

Organization

Kyushu Dental University

Division name

Department of Oral Reconstruction and Rehabilitation

Zip code


Address

2-6-1 Manazuru, Kokurakita, Kitakyushu, Fukuoka

TEL

093-285-3100

Homepage URL


Email

masaki@kyu-dent.ac.jp


Sponsor or person

Institute

Department of Oral Reconstruction and Rehabilitation, Kyushu Dental University

Institute

Department

Personal name



Funding Source

Organization

internal fund

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


Email



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

九州歯科大学病院(福岡県),たかはし歯科(愛媛県),つかもと歯科・小児歯科医院(佐賀県),吉田歯科医院(大阪府),原歯科医院(佐賀県),あべやま歯科クリニック(福岡県),中村歯科医院(佐賀県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Although the number of bacteria decreased after the administration of azithromycin in both groups, they increased again thereafter. No significant difference was observed in bacterial numbers between the two groups. Although PPD in the probiotics group was significantly lower at 4 and 24 weeks than at 0 weeks (p < 0.05), a significant decrease did not occur in the placebo group. The mBI score at 24 weeks was significantly lower in the probiotics group than in the placebo group (p <0.05). No significant difference was observed in BOP or mPI between the two groups.

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

Completed

Date of protocol fixation

2015 Year 07 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date

2017 Year 01 Month 08 Day

Date of closure to data entry

2017 Year 03 Month 30 Day

Date trial data considered complete

2017 Year 03 Month 30 Day

Date analysis concluded

2017 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 01 Month 23 Day

Last modified on

2017 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name