UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034617 |
|---|---|
| Receipt number | R000039467 |
| Scientific Title | Deviations in palatal region between indirect and direct digital models |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2018/10/24 12:42:32 |
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Basic information
Public title
Deviations in palatal region between indirect and direct digital models
Acronym
Trueness of intraoral digital model over palatal region
Scientific Title
Deviations in palatal region between indirect and direct digital models
Scientific Title:Acronym
Trueness of intraoral digital model over palatal region
Region
| Asia(except Japan) |
Condition
Condition
Accuracy of intraoral scanners in oral environment.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence on trueness of intraoral palatal scans by using different scanning sequences; and to assess deviation and its distribution character of trueness in the palatal region.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scanning sequences can affect palatal trueness of intraoral digital models. By a modified regional model superimposition, the 3D measurements of palatal trueness in Intraoral scanning Groups, in which intraoral scanning sequences over palatal region were different, were slightly statistically significant.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Permanent dentition, including premolars extracted for past orthodontic treatment;
2. Good oral hygiene;
3. Good cooperation to finish all data acquisition.
Key exclusion criteria
1. Undergoing orthodontic treatment or finished orthodontic treatment for no more than 2 years;
2. With more than one-third of tooth defect on a single tooth;
3. With large amounts of metal restorations;
4. With severe crowding or obvious spaces;
5. With palatal defect or lesion;
6. With an abnormally large arch width between bilateral upper first molars;
7. Moderate to severe periodontitis or obvious gingivitis.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiang Ruoping |
Organization
Peking University School and Hospital of Stomatology
Division name
Department of Orthodontics
Zip code
Address
No.22 Zhongguancun South Avenue, Haidian district, Beijing, China
TEL
+86-13693223635
jiangruoping@126.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yang Zhongpeng |
Organization
Peking University School and Hospital of Stomatology
Division name
Department of Orthodontics
Zip code
Address
No.22 Zhongguancun South Avenue, Haidian district, Beijing, China
TEL
+86-15101509961
Homepage URL
zhongpeng_yang@163.com
Sponsor or person
Institute
Peking University School and Hospital of Stomatology
Institute
Department
Personal name
Funding Source
Organization
Beijing Manicipal Science & Technology Commission
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By observation, the majority (22/35) of participants from both Intraoral scanning Groups, in which scanning sequences were different, presented a similar pattern of palatal trueness.
Management information
Registered date
| 2018 | Year | 10 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039467
