Clinical success of maxillary incisors intrusion by using mini screw
Design
30 patients with at least 4mm deep bite and gummy smile from patients referring to orthodontics department of Mashhad Dental School. We divide these patients into two randomly selected blocks after initial leveling and alignment.
Settings and conduct
In a group, using 2 mini screws and in another group, using the usual Burston, segmented arch, for maxillary incisors intrusion.After 6 months, or after intrusion has been completed, we rate the intrusion and root resorption and gingival display and incisors protrusion and periodontal index measures.There is no possibility of blinding in the study. People are selected and treated at Mashhad Dental School.
Participants/Inclusion and exclusion criteria
People entering the study:Post pubertal patients who have gummy smile and are suitable for the true intrusion of the anterior maxillary teeth.
Failure to enter the study:occurrence of specific medical conditions,trauma,root resorption before orthodontic therapy,previous orthodontic treatment
Intervention groups
In the intervention group, we use two mini scropers between the lateral and canine maxilla in the mucogingival line.
In the control group, the usual method of intrusion is through the Burston, segmented arch.
Main outcome variables
Intrusion Rate Over 6 Months;Reduced Overbite;Reduced Gingival Display In Voluntary Smile;Root resorption;Maxillary Incisor Tiping;Sulcus Depth Changes;Keratinized Gingiva and Sticky Gums;Bleeding on Probing;crestal resorption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180929041176N1
Registration date:2019-02-24, 1397/12/05
Registration timing:registered_while_recruiting
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
َAlireza Chamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 3822
Email address
chamania961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical success of maxillary incisors intrusion by using mini screw
Public title
Clinical success of maxillary incisors intrusion by using mini screw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
post pubertal patient
gummy smile(high gingival display at social smile)
good for maxillary incisors intrusion
Exclusion criteria:
Occurrence of special medical conditions
trauma
root resorption before orthodontic therapy
Previous orthodontic or orthopedic treatment
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block method
Considering that 30 patients should be placed in two groups, the blocks of 6 are AAABBB, AABABB, ABBAAB, BBBAAA, BBABAA, BAABBA, so that the number of samples in each group is identical.Then select random numbers between one to six (for example, 1 4 5 and ...)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Faculty of Dentistry, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-11-26, 1397/09/05
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.101
Health conditions studied
1
Description of health condition studied
Gummy Smile
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of decrease gingival display after intrusion
Timepoint
Before intrusion and after 6 month
Method of measurement
Smile analyzer software
Secondary outcomes
1
Description
Amount of root resorption after intrusion
Timepoint
Before and 6 mounth after intrusion
Method of measurement
Periapical Radiography
Intervention groups
1
Description
Intervention group: We will insert 2 mini screw between the lateral and canine of maxilla and intrude the anterior segments.
Category
Treatment - Other
2
Description
Control group: Anterior segmentation intrusion is performed with the Burston segmented arch .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry of Mashhad
Full name of responsible person
Farzin Heravi
Street address
Faculty of dentistry, Vakil abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
farzinheravi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Heravi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Vakil abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
farzinheravi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzin Heravi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Vakil abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
farzinheravi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
َAlireza Chamani
Position
Resident of orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 102 , 9 jalal al ahmad Blvd., vakil abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188875155
Phone
+98 51 3604 3822
Fax
Email
chamania961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available