The aim was to investigate the effect of activator high pull headgear with lip exercises on closing the inter labial gap in patients with class II malocclusion and long face in 1400-99 at the Azad Dentistry University.
Design
This study is a clinical trial and we need 30 orthodontic patients. Patients are randomly divided into two groups of 15 with random number generator app. Which is a group as a control group and the groups are parallel.
Settings and conduct
All patients are photographed with the camera in natural head position mode in three frontal, frontal in smile and profile views. Then Inter-labial gap, upper and lower lip length, upper and lower lip vermilium were clinically calibrated with collis with a precision of 0.02 mm and the nasolabial angel and angel of convexity will be measured with the help of pictures. All patients are given an activator high pull headgear . A group of people will be taught the lip exercises that include placing the thumb inside the upper lip vestibule and the other 4 fingers outside the lip under the nose and pulling lips down for 20 seconds and also massage the upper lip downwards with the thumb for 20 seconds. The other group completes their treatment without lip training. The study groups are not aware of the presence of other participants in the study.
Participants/Inclusion and exclusion criteria
No history of orthodontic treatment;
presence before the age of physical maturity defined for girls 9 to 11 years and for boys 10 to 12 years;
skeletal class II;
long face;
lip incompetent
Intervention groups
Patients are randomly divided into two groups of 15 people, both groups are prescribed an activator headgear, and only one group will be taught the exercises to increase lip length.
Main outcome variables
inter labial gap; nasolabial angel; angel of convexity; upper and lower lip length; upper and lower vermilium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200707048046N1
Registration date:2021-01-19, 1399/10/30
Registration timing:prospective
Last update:2021-01-19, 1399/10/30
Update count:0
Registration date
2021-01-19, 1399/10/30
Registrant information
Name
Atiye Safaralizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 0210
Email address
aty.alizade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lip exercise with activator headgear on the inter labial gap on class II division 1 and long face patients
Public title
Effect of lip exercise with activator headgear on the inter labial gap on class II division 1 and long face patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Skeletal class II Div.1
Long face
Lip incompetent
Exclusion criteria:
Orthodontic history
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Samples that were entered into the intervention group according to the lottery will receive instructions on how to perform lip exercises without informing the other participants.
Also, the person who analyzes the data will analyze the information without knowing the grouping of people and every person in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Dental Branch of Medical Sciences
Street address
No.9, Ninth Neyestan, Pasdaran Ave, Tehran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.183
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
inter labial gap
Timepoint
At the time of receiving the orthodontic appliance and at the end of the treatment
Method of measurement
from patient with collis
2
Description
upper lip length
Timepoint
At the time of receiving the orthodontic appliance and at the end of the treatment
Method of measurement
from patient with collis
3
Description
upper lip Vermilium
Timepoint
At the time of receiving the orthodontic appliance and at the end of the treatment
Method of measurement
from patient with collis
4
Description
lower lip length
Timepoint
At the time of receiving the orthodontic appliance and at the end of the treatment
Method of measurement
from patient with collis
5
Description
lower lip vermilium
Timepoint
At the time of receiving the orthodontic appliance and at the end of the treatment
Method of measurement
from patient with collis
Secondary outcomes
1
Description
Nasolabial angle
Timepoint
During orthodontic treatment
Method of measurement
With a protractor from the image
2
Description
angle of convexity
Timepoint
During orthodontic treatment
Method of measurement
With a protractor from the image
Intervention groups
1
Description
Control group: receiving orthodontic appliance, activator high pull headgear and using it for 14 hours during the day
Category
Treatment - Devices
2
Description
Intervention group: Receiving orthodontic appliance along with the upper lip exercises so that it takes the upper lip with 4 fingers from the outside and the thumb from the inside and pulls it down for 20 seconds. Perform this exercise 3times a day and 5times each time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Islamic Azad University of Dental Branch of Medical Sciences
Full name of responsible person
Dr. Afshin Haraji
Street address
No.9, ninthth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
aty.alizade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
No.9, ninth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
aty.alizade@yahoo.com
Web page address
http://dental.iautmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?