UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study about utility of blood IgG antibody titer against periodontal pathogen for prediction of development of peri-implantitis
Title of the study (Brief title)	Pilot study about utility of examination for degree of periodontal infection in peri-implantitis
Region	Japan

Condition
Condition	Periodontal Disease Peri-implantitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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)

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Shogo Takashiba
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Biopathological Science
Division name	Department of Pathophysiology - Periodontal Science
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6675
Email	stakashi@okayama-u.ac.jp

Public contact
Name of contact person	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Phar
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6675
Homepage URL
Email	stakashi@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	岡山大学病院，神奈川歯科大学附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/shikahozon/59/2/59_178/_pdf
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.
Other related information

Management information
Registered date	2014 Year 01 Month 27 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014125