UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059266 |
|---|---|
| Receipt number | R000066405 |
| Scientific Title | Observation of the effects of non-surgical periodontal treatment on vascular function and biomarkers in blood and saliva |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/02 11:36:19 |
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Basic information
Public title
Observation of the effects of non-surgical periodontal treatment on vascular function and biomarkers in blood and saliva
Acronym
Observation of the effects of non-surgical periodontal treatment on vascular function and biomarkers in blood and saliva
Scientific Title
Observation of the effects of non-surgical periodontal treatment on vascular function and biomarkers in blood and saliva
Scientific Title:Acronym
Observation of the effects of non-surgical periodontal treatment on vascular function and biomarkers in blood and saliva
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether full-mouth debridement using Er:YAG laser reduce periodontal parameters and systemic effects compared to treatment using ultrasonic scaler.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva CRP concentration on one day after intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Interventions / Subgingival debridement of the full mouth completed in one session using an Er:YAG laser.
Interventions/Control_2
Control / Subgingival debridement of the full mouth completed in one session using an ultrasonic scaler.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Generalized stage II to IV periodontitis, (b) 12 or more remaining teeth.
Key exclusion criteria
(a) Less than 12 remaining teeth (excluding third molars and remaining roots), (b) Periodontal treatment received in the past year, (c) Systemic diseases that may affect periodontitis or periodontal treatment, (d) Pregnant or breastfeeding women, (e) Systemic administration of antibiotics or anti-inflammatory analgesics within three months prior to periodontal examination.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Sekino |
Organization
The Nippon Dental University School of Life Dentistry at Tokyo
Division name
Department of Periodontology
Zip code
102-8159
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
0332615937
sekino-s@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Takeya |
Organization
The Nippon Dental University School of Life Dentistry at Tokyo
Division name
Department of Periodontology
Zip code
102-8159
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
08054862649
Homepage URL
s-takeya5122021@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nippon Dental University
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
Tel
03-3261-8311
s-takeya5122021@tky.ndu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066405
