UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060104 |
|---|---|
| Receipt number | R000068739 |
| Scientific Title | A study investigating the relationship between changes in tooth mobility before and after anchor screw placement, anchor screw failure rates, and the distance between the anchor screw and the tooth root |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/17 19:35:32 |
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Basic information
Public title
Study on the relationship between the stability of orthodontic anchor screws, tooth mobility, and the distance to tooth roots
Acronym
Anchor Screw & Root Distance
Scientific Title
A study investigating the relationship between changes in tooth mobility before and after anchor screw placement, anchor screw failure rates, and the distance between the anchor screw and the tooth root
Scientific Title:Acronym
Anchor Screw & Root Distance
Region
| Japan |
Condition
Condition
Malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the relationships among changes in tooth mobility before, during, and after orthodontic anchor screw placement, the failure rate of orthodontic anchor screws, and the distance between the orthodontic anchor screw and the tooth root, using tooth mobility measuring devices (AnyCheck or Periotest).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tooth mobility, Failure rate of orthodontic anchor screws, Distance between the orthodontic anchor screw and the tooth root
Key secondary outcomes
Insertion torque of orthodontic anchor screws, Oral diseases, Maxillofacial morphology
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
| 18 | years-old | <= |
Age-upper limit
| 49 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inpatient/Outpatient at the research implementation facility
Key exclusion criteria
* Uncontrolled severe systemic diseases
* Uncontrolled bleeding disorders
* Patients with drug, alcohol, or nicotine addiction
* Long-term treatment-resistant functional impairment
* Xerostomia
* Opportunistic immunodeficiency and leukocyte dysfunction
* Diseases requiring regular steroid administration
* Uncontrolled endocrine diseases
* Patients with hypersensitivity to pure titanium or titanium alloys
* Patients with impaired wound healing function
* Patients receiving bisphosphonates
* Patients with poor general condition
* Patients with lesions such as inflammation, tumors, cysts, or trauma at or around the implantation site
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YASUHIKO |
| Middle name | |
| Last name | OGA |
Organization
Kagoshima University Hospital
Division name
Orthodontics
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
TEL
099-275-6252
yasuhiko_oga@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | YOSHIKO |
| Middle name | |
| Last name | HIRANO |
Organization
Kagoshima University Hospital
Division name
Orthodontics
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
TEL
099-275-6252
Homepage URL
k9956605@kadai.jp
Sponsor or person
Institute
Department of Orthodontics, Kagoshima University Hospital
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Sakuragaoka Area, Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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 | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Prospective cohort study
Tooth mobility of adjacent teeth will be measured before and after orthodontic anchor screw placement. If deemed clinically necessary, X-ray examinations (including CT imaging) will be performed. Participants will be divided into two groups: those with changes in tooth mobility before and after placement and those without. Tooth mobility will be measured 1 to 3 months after placement to identify a threshold for predicting orthodontic anchor screw failure.
1) Samples and Information Used in the Study
(1) Specific Content
-Tooth mobility measurement values (results measured by AnyCheck, Periotest, etc.)
-X-ray and CT images
-Insertion torque values of orthodontic anchor screws
-Patient background information (age, sex, type of malocclusion, etc.)
(2) Data Collection Methods
-Tooth mobility will be measured using AnyCheck, Periotest (tooth mobility measuring devices), or similar devices.
-X-ray and CT imaging of the orthodontic anchor screw implantation site will be performed as necessary.
-Maximum insertion torque will be measured and recorded during orthodontic anchor screw placement.
-Patient background information will be collected from medical records and oral interviews.
(3) Collection Period
The data collection period is from July 1, 2024, to March 31, 2029. The study targets patients who undergo orthodontic anchor screw placement during this period.
2) Analysis Methods
Data obtained from the study samples will be statistically analyzed to detect the presence or absence of root contact with high accuracy.
Management information
Registered date
| 2025 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068739
