Protocol summary

Summary
Innovations in the appearance of orthodontic appliances may be a major factor in the increasing acceptability of orthodontic treatment for adults. Adults considering treatment now have a choice in the type of aesthetic appliance design including clear plastic aligners. This interventional study is designed to evaluate the treatment efficacy of clear aligners. Twenty patients will be selected nonrandomly among the patients referred to Kerman dentistry school. There is no control group in this study. Inclusion criteria will be: mild to moderate crowding; mild to moderate spacing; Class I molar relationship; patients of 13 years or over; permanent dentition without any pre-extraction or oral lesion. Exclusion criteria will be: patients in need of fixed appliance therapy and orthognathic surgery treatments; patients with systemic diseases, malformations and syndromes. Duration of treatment will be about 2 years. Final Virtual models that predict final teeth positions will be superimposed on virtual models achieved at the end of treatment. Efficacy analysis will be reported by Orthostudio software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061834617N1
Registration date: 2017-07-27, 1396/05/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Mohammad Mousavi
Name of organization / entity
Kerman Medical University
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5700
Email address
nedasinaee@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of tooth movement using Smilelign clear aligners in othrodontic patients
Public title
Evaluation of the efficacy of orthodontic tooth movement using clear aligners
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria will be: mild to moderate crowding; mild to moderate spacing; Class I molar relationship; patients of 13 years or over; permanent dentition without any pre-extraction or oral lesion. Exclusion criteria will be: patients in need of fixed appliance therapy or orthognathic surgery treatments; patients with systemic diseases, malformations and syndromes.
Age
From 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Technology Vice-Presidency of Kerman University of Medical Sciences
Street address
Tahmasb abad square, Kerman, Iran
City
Kerman
Postal code
1355576169
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.KMU.REC.1395.821

Health conditions studied

1

Description of health condition studied
Evaluation of the efficacy of tooth movement using Smilelign clear aligners in othrodontic patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Dental rotation
Timepoint
At the end of treatment
Method of measurement
Orthostudio software

2

Description
Tipping of tooth crown
Timepoint
At the end of treatment
Method of measurement
Orthostudio software

3

Description
Labiolingual crown torque
Timepoint
At the end of treatment
Method of measurement
Orthostudio software

4

Description
Dental Intrusion/Extrusion
Timepoint
At the end of treatment
Method of measurement
Orthostudio software

Secondary outcomes

1

Description
Failure in correction of dental crowding
Timepoint
At the end of treatment
Method of measurement
Orthostudio software

Intervention groups

1

Description
Orthodontic treatment using clear aligners
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontic Department,Kerman Dental School
Full name of responsible person
Mohammad Mousvi,Postgraduate student of Orthodontics
Street address
Orthodontic Department, Kerman Dental School, Shafa Street, Kerman, Iran
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Mohammad Mousavi
Street address
Orthodontic Department, Kerman Dental School, Shafa Street, Kerman, Iran
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical sciences
Full name of responsible person
Mohammad Mousavi
Position
Postgraduate student of orthodontics
Other areas of specialty/work
Street address
Orthodontic Department, Kerman Dental School, Shafa Street, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3247 7033
Fax
Email
nedasinaee@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical sciences
Full name of responsible person
Dr Neda Sinaee
Position
Assistant professor at Orthodontic department
Other areas of specialty/work
Street address
Orthodontic Department, Kerman Dental School, Shafa Street, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3247 7033
Fax
Email
nedasinaee@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical sciences
Full name of responsible person
Mohammad Mousavi
Position
Postgradute student of Orthodontics
Other areas of specialty/work
Street address
Orthodontic Department, Kerman Dental School, Shafa Street, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3247 7033
Fax
Email
nedasinaee@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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