The aim of this study is to compare the effect of traditional twin block and clear twin block on speech of class II skeletal patients.
Design
A randomized clinical trial with a control and parallel groups design of 18 patients, enrolled and followed for three months after starting treatment. Participants were blinded by how the groups were allocated.
Settings and conduct
The study will be performed on patients with class II malocclusion in Tabriz faculty of dentistry. To evaluate the effect of the appliance on patients' speech, the patient's speech will be evaluated at the times: before receiving the appliance, immediately after receiving the appliance, one month after receiving the appliance and three months after receiving the appliance. Speech assessment consists of two parts: vowels and syllables. Patients' speech samples will be recorded and then examined for vowel formants and number of distortions. Speech performance will be compared in two groups of control and intervention and the performance of each group will be compared at different times.
Participants/Inclusion and exclusion criteria
inclusion criteria: being literate, no cognitive problems, no cleft lip and palate, no neurological problems, no phonological and articulation problems and no hearing loss.
Intervention groups
treatment group: class II patients that use traditional twinblock appliance.
control group: class II patients that use clear twinblock appliance.
Main outcome variables
first formants of vowels
second formants of vowels
third formants of vowels
number of distortions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210927052606N1
Registration date:2021-10-25, 1400/08/03
Registration timing:registered_while_recruiting
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Mahsa Zali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3442 7984
Email address
m.mahsa.zali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-16, 1400/07/24
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of traditional and clear twin block on the speech of skeletal class II patients
Public title
Comparison of the effect of traditional and clear twin block on the speech of skeletal class II patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being literate
no cognitive problems
no cleft lip and palate
no neurological problems
no articulation and phonological disorders
no hearing loss
Exclusion criteria:
Age
From 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization method will be used and, groups assingments will be determined by flipping coin.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know about the allocation of study groups. What device each patient receives is selected randomly by another person without their knowledge. The patient is not aware that he is in the case or control group, but the researchers are aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
No. 26, avval ordibehesht alley ., 22bahman Ave., tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5178647435
Approval date
2021-03-12, 1399/12/22
Ethics committee reference number
IR.TUMS.FNM.REC.1399.236
Health conditions studied
1
Description of health condition studied
class II malocclusion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of malfunctions: The number of sounds that have been altered and the sound produced is not phonetically accurate enough.
Timepoint
Before - immediately - one month and three months after receiving the appliance.
Method of measurement
Recording with microphone praat software.
2
Description
First Formant of vowels: A formant that relates to the height of the tongue when producing a vowel.
Timepoint
Before - immediately - one month and three months after receiving the appliance.
Method of measurement
Recording with microphone praat software.
3
Description
Second Formant of vowels: A formant that relates to the amount of tongue protrusion when producing a vowel.
Timepoint
Before - immediately - one month and three months after receiving the appliance.
Method of measurement
Recording with microphone praat software.
4
Description
Third Formant of vowels: A formant that relates to the amount of roundness of the lips when producing a vowel.
Timepoint
Before - immediately - one month and three months after receiving the appliance.
Method of measurement
Recording with microphone praat software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that receives the clear twin block appliance. This device should be used by the patient at all times except when eating and brushing.
Category
Treatment - Devices
2
Description
Control group: The group that receives the traditional twin block appliance. This device should be used by the patient at all times except when eating and brushing.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz dentistry faculty
Full name of responsible person
ahmad behroozian
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
info@dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3177 1041
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
dr.ahmad behroozian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
ahmadbehroozian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr.ahmadbehroozian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN