UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007484 |
|---|---|
| Receipt number | 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 22:38:07 |
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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
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
moro@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008828
