UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059157 |
|---|---|
| Receipt number | R000067668 |
| Scientific Title | Cohort study of gingival recession utilizing an intraoral scanner and root caries |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/22 14:28:21 |
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Basic information
Public title
Prospective study of gingival recession utilizing an intraoral scanner and root caries
Acronym
Prospective study of gingival recession and root caries
Scientific Title
Cohort study of gingival recession utilizing an intraoral scanner and root caries
Scientific Title:Acronym
Cohort study of gingival recession and root caries
Region
| Japan |
Condition
Condition
Gingival recession, Root caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Characterize the extent and location of gingival recession in patients with the recession, and evaluate dental indicators and lifestyle factors associated with long-term progression of gingival recession and development of root caries.
Basic objectives2
Others
Basic objectives -Others
Amount of gingival recession, Root caries
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of gingival recession, Root caries
Key secondary outcomes
Age
Gender
Number of teeth
Dental formula
Types of oral hygiene tools used daily
Toothbrush bristle hardness
Tooth brushing time per session
Daily tooth brushing frequency
Awareness of avoiding excessive brushing force
History of orthodontic treatment
Presence of daily dry mouth sensation (excluding upon waking or during times of tension)
Medication status
Report of teeth grinding during sleep
Presence of jaw pain or fatigue upon waking
Self awareness of gingival recession
Dominant hand used for holding toothbrush during brushing
Plaque Control Record (PCR)
Probing Pocket Depth (PPD)
Bleeding On Probing (BOP)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged between 40 and 79 years.
Presence of more than 20 natural teeth and gingival recession in at least one tooth.
No untreated root caries observed.
Regular visits to the Senri Dental Clinic affiliated with the Sunstar Foundation.
Written informed consent obtained from participants after explanation by investigators using study information documents.
Key exclusion criteria
Pregnancy or lactation.
Current orthodontic treatment.
Presence of areas difficult to capture with intraoral scanning (e.g., severe dental crowding).
Periodontal surgery within the previous 3 months.
Other individuals deemed unqualified by the examining dentist or dental hygienist.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kato |
Organization
Sunstar Inc.
Division name
Oral care, R&D
Zip code
569-1195
Address
3-1 Asahi-machi, Takatsuki, Osaka, Japan
TEL
08099374061
keisuke.kato@sunstar.com
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Kondo |
Organization
Sunstar Inc.
Division name
Oral care, R&D
Zip code
569-1195
Address
3-1 Asahi-machi, Takatsuki, Osaka, Japan
TEL
08083034326
Homepage URL
minami.kondo@sunstar.com
Sponsor or person
Institute
Sunstar Inc.
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sunstar Foundation
Name of secondary funder(s)
8020 Promotion Foundation
IRB Contact (For public release)
Organization
Validity Evaluation Committee, Sunstar Inc.
Address
Asia One Center 8F, 1-17 Koyochonaka, Higashinada-ku, Kobe, Hyogo, Japan
Tel
08083359125
takeshi.kanamori@sunstar.com
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
・サンスター株式会社（大阪府）
・一般財団法人サンスター財団附属千里歯科診療所（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | 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
62
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067668
