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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007484
Receipt No. R000008828
Scientific Title Microbiological effect of subgingival ultrasonic instrumentation irrigated with essential oil antiseptic in shallow and deep pockets: a 7-day randomized controlled trial
Date of disclosure of the study information 2012/03/10
Last modified on 2012/03/10

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Basic information
Public title Microbiological effect of subgingival ultrasonic instrumentation irrigated with essential oil antiseptic in shallow and deep pockets: a 7-day randomized controlled trial
Acronym Microbiological effect of essential oils in various periodontal pockets
Scientific Title Microbiological effect of subgingival ultrasonic instrumentation irrigated with essential oil antiseptic in shallow and deep pockets: a 7-day randomized controlled trial
Scientific Title:Acronym Microbiological effect of essential oils in various periodontal pockets
Region
Japan

Condition
Condition Chronic periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the microbiological effect of subgingival ultrasonic instrumentation irrigated with essential oils in various periodontal pocket depths.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The adjunctive use of essential oils might be effective in reducing subgingival bacterial counts in deep pockets.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Subgingival ultrasonic instrumentation was performed for 10 min using 100 ml of essential oils (Fresh Mint Listerine) as the irrigation agent. Subsequently, mouthrinsing at home four times daily for 20 sec with 20 ml of essential oils was continued for 7 days.
Interventions/Control_2 Subgingival ultrasonic instrumentation was performed for 10 min using 100 ml of saline (Otsuka normal saline) as the irrigation agent. Subsequently, mouthrinsing at home four times daily for 20 sec with 20 ml of saline was continued for 7 days.
Interventions/Control_3 No treatment was done.
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
40 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Systemically healthy subjects who possessed a minimum of 20 teeth and had generalized moderate-to-severe chronic periodontitis, which was defined as having at least three teeth with probing pocket depth greater than 5 mm in each quadrant, are selected.
Key exclusion criteria Subjects with the following conditions were excluded: patients who had taken systemic antibiotics, anti-inflammatory drugs or immunosuppressive drugs within 3 months before the experiment. Subjects, who had received periodontal treatment within the previous 6 months, regularly use an oral irrigation device and/or mouth rinse, and had an incompatible dentition, e.g., orthodontic bands, partial dentures or teeth unsuitable for extensive ultrasonic scaling, were also excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Hiromasa Yoshie, DDS, PhD
Organization Niigata University
Division name Division of Periodontology
Zip code
Address 2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiya Morozumi, DDS, PhD
Organization Niigata University
Division name Division of Periodontology
Zip code
Address
TEL
Homepage URL
Email moro@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 Niigata University Medical & Dental Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2005 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 10 Day
Last modified on
2012 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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