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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034617
Receipt No. 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

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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
Email 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
Email zhongpeng_yang@163.com

Sponsor
Institute Peking University School and Hospital of Stomatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039467

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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