UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048746 |
|---|---|
| Receipt number | R000055536 |
| Scientific Title | The prevalence and progression of dental erosion in patients with gastroesophageal reflux disease (GERD) and non-GERD |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2025/02/25 09:07:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prevalence and progression of dental erosion in patients with gastroesophageal reflux disease (GERD) and non-GERD
Acronym
The prevalence and progression of dental erosion in patients with gastroesophageal reflux disease (GERD) and non-GERD
Scientific Title
The prevalence and progression of dental erosion in patients with gastroesophageal reflux disease (GERD) and non-GERD
Scientific Title:Acronym
The prevalence and progression of dental erosion in patients with gastroesophageal reflux disease (GERD) and non-GERD
Region
| Japan |
Condition
Condition
gastro-esophageal reflux disease (GERD)
dental erosion
Classification by specialty
| Hepato-biliary-pancreatic medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the prevalence and progression of dental erosion in patients with GERD and non-GERD.
Basic objectives2
Others
Basic objectives -Others
prevalence and progression
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the prevalence and progression of GERD and non-GERD
the prevalence of progression of dental erosion
Key secondary outcomes
the properties of saliva
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with GERD (including reflux esophagitis and non-erosive gastroesophageal reflux disease) during routine medical care and have GERD symptoms
Key exclusion criteria
wearing dental orthodontic appliances
presented with trismus
bleached or discolored anterior teeth
full coverage restorations (crowns etc) on any of four minimum teeth present
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kitasako |
Organization
Tokyo Medical and Dental University
Division name
Cariology and Operative Dentistry
Zip code
113-8549
Address
5-45 Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-5483
kitasako.ope@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kitasako |
Organization
Tokyo Medical and Dental University
Division name
Cariology and Operative Dentistry
Zip code
113-8549
Address
5-45 Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-5483
Homepage URL
kitasako.ope@tmd.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
kitasako.ope@tmd.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
日本医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-21K09889/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-21K09889/
Number of participants that the trial has enrolled
300
Results
There was a significant association of the prevalence and severity between reflux esophagitis (RE) and Dental Erosion (DE), while there was no significant correlation between the prevalence of non-erosive reflux disease (NERD) and DE. Saliva secretion, severity of RE and Proton pump inhibitor resistance were associated with the prevalence of DE, while age, BMI, and severity of RE were associated with the severity of DE. Lower saliva secretion and BMI were significant factors for DE.
Results date posted
| 2024 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 04 | Day |
Baseline Characteristics
We enrolled consecutive patients with reflux esophagitis and those with NERD as well as healthy individuals as healthy controls.
Participant flow
Patients were excluded if they were cigarette smokers, presented with the long segment Barrett's esophagus (under 3cm) based on endoscopic visualization, wearing dental orthodontic appliances, trismus, bleached or discolored teeth. Patients receiving agents confirmed to reduce the secretion of saliva, such as antihypertensive agents (anti-adrenergic agents and adrenergic alpha-2 agonists), antidepressants, psychotropic drugs, or anticholinergic drugs were also excluded. The individual dietary history was used to exclude subjects with high consumption of acidic drinks and foods.
Adverse events
None
Outcome measures
Endoscopy: evaluation of presence and severity of reflux esophagitis and non-erosive gastroesophageal reflux disease
Oral evaluation: presence and severity of dental erosion
Saliva test: saliva flow rate and saliva buffer capacity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
case control study
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055536
