UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Deviations in palatal region between indirect and direct digital models
Title of the study (Brief title)	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	Jiang Ruoping
Organization	Peking University School and Hospital of Stomatology
Division name	Department of Orthodontics
Address	No.22 Zhongguancun South Avenue, Haidian district, Beijing, China
TEL	+86-13693223635
Email	jiangruoping@126.com

Public contact
Name of contact person	Yang Zhongpeng
Organization	Peking University School and Hospital of Stomatology
Division name	Department of Orthodontics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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