UMIN-CTR Clinical Trial

Public title

Pilot study about utility of blood IgG antibody titer against periodontal pathogen for prediction of development of peri-implantitis

Acronym

Pilot study about utility of examination for degree of periodontal infection in peri-implantitis

Scientific Title

Pilot study about utility of blood IgG antibody titer against periodontal pathogen for prediction of development of peri-implantitis

Scientific Title:Acronym

Pilot study about utility of examination for degree of periodontal infection in peri-implantitis

Region

Japan

Condition

Periodontal Disease
Peri-implantitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim is to investigate the state about oral implant therapy and to examine about utility of blood IgG antibody titer against periodontal pathogen as infection marker of peri-implantitis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Test for plasma IgG antibody titer to periodontal pathogen

Key secondary outcomes

1.Items about the patient's information and lifestyle
2. Oral examination: Number of implant, Average holding period of implant (year), The sites of implants in oral[Upper molar region, Upper anterior teeth, Lower molar region, Lower anterior teeth], Presence or absence of a history about tooth loss by periodontal disease, Variation of missing teeth [Kennedy classification],
3.Saliva test for the quantity of periodontal pathogen (PCR method)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Periodontal patients with oral implant treatment history under Supportive Periodontal Treatment are performed plasma IgG antibody titer to periodontal pathogens once.

Interventions/Control_2

Non-Periodontal patients with oral implant treatment history are performed plasma IgG antibody titer to periodontal pathogens

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Periodontal patients with oral implant treatment history under Supportive Periodontal Treatment

2. Non-Periodontal patients with oral implant treatment history

Key exclusion criteria

inflammation in oral cavity
pre-existing diseases
any medication

Target sample size

105

Name of lead principal investigator

1st name
Middle name
Last name	Shogo Takashiba

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Biopathological Science

Division name

Department of Pathophysiology - Periodontal Science

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-6675

Email

stakashi@okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shogo Takashiba

Organization

Okayama University

Division name

Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Phar

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-6675

Homepage URL

Email

stakashi@cc.okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岡山大学病院，神奈川歯科大学附属病院

Date of disclosure of the study information

2014

Year

01

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.jstage.jst.go.jp/article/shikahozon/59/2/59_178/_pdf

Number of participants that the trial has enrolled

Results

Results: Significantly more patients with BRIS were undergoing PSPT than PM. Significantly more patients with plasma IgG antibody titer to Porphyromonas gingivalis (P.g-IgG titer) not less than 1.68 were undergoing PSPT than PM. Also, significantly more patients with Tannerella forsythia in saliva were undergoing PSPT than PM. Significantly more patients with P.g-IgG titer not less than 1.68 and patients with T. forsythia in saliva were undergoing P with BRIS than P without BRIS.

Conclusion: Periodontal bacteria-related examinations using blood and saliva may be useful as prognostic factors for periimplantitis.

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

12

Month

27

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

01

Month

27

Day

Last modified on

2016

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014125