UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045863 |
|---|---|
| Receipt number | R000052352 |
| Scientific Title | Changes in biological responses and autonomic nervous activity after scaling and the suppressive effect of phototherapy |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2024/06/04 16:45:07 |
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Basic information
Public title
Changes in biological activity and stress after dental calculus removal and the effect of phototherapy
Acronym
Biological changes after tartar removal and the effect of phototherapy
Scientific Title
Changes in biological responses and autonomic nervous activity after scaling and the suppressive effect of phototherapy
Scientific Title:Acronym
Inhibitory effect of phototherapy on biological changes after scaling
Region
| Japan |
Condition
Condition
Moderate to severe chronic periodontitis (stage II-IV, grade A-B)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effectiveness of Er: YAG laser on biological responses and changes in stress markers after scaling in the elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytokine expression level in serum
Key secondary outcomes
Blood endotoxin level
Stress marker level
Periodontal examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Test group
1.26 patients
2. Patients receive subgingival scaling using Er: YAG laser once
Interventions/Control_2
Control group
1. 26 patients
2. Patients scaling and root planning as using hand scaler once
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Three or more remaining teeth with periodontal pockets of 5 mm or more on the same side
Key exclusion criteria
1. Persons who had received scaling and root planing within the previous 6 months
2. Persons who had taken systemic antibiotics or anti-inflammatory drugs within 3 months before experiment
3. Persons who had severe systemic diseases
4. Smoker
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Morozumi |
Organization
Kanagawa Dental University
Division name
Department of Periodontology
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka
TEL
+81(46)822-8855
morozumi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Morozumi |
Organization
Kanagawa Dental University
Division name
Department of Periodontology
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka
TEL
+81(46)822-8855
Homepage URL
morozumi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Periodontology, Graduate School of Medical and Dental Science, Niigata University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University Research Ethics Review Committee
Address
82 Inaoka-cho, Yokosuka
Tel
+81(46)822-8813
kenkyo@kdu.ac.jp
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
神奈川歯科大学附属病院（神奈川県）
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 25 | 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
32
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because data analysis is in progress.
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
| 2021 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052352
