study the effect of low level laser in the treatment of class II patients with mandibular deficiency treated with Farmand functional appliance
Design
Clinical trial,with two groups(Farmand,Farmand+laser),factorial groups, double-blind, randomized on 22 patients. Graph pad software will be used for randomization.
Settings and conduct
The study is performed in Shahid Sadouqi Dental School of Yazd. After construction of Farmand appliance, lateral cephalometric radiography is taken for each patient. Patients of first group(Farmand)use only the functional appliance. For second group(Farmand+laser)after 1month of using the appliance until the end of treatment,once a week(12 sessions) laser(GaA1As 980nm diode)is irradiated at 4 points around the TMJ and 100 seconds for each point.
After the period of functional therapy(6 months)radiographs are taken again from all patients and then we measure specific quantities in the pre and post treatment radiographs.
Except the laser device operator,patients(in first group,laser applicator without radiation are placed),therapist,researcher and data analyst are unaware of which patient receive the laser.
Participants/Inclusion and exclusion criteria
Inclusion:
1- Age range 10to13 years for girls and 11to14 years for boys
2- Patient's profile in clinical view shows the pattern of skeletal class II with mandibular deficiency.
3- Dental canine and molar class II relationship.
Non inclusion:
1- History of diseases affecting the growth process
2- History of jaw surgery
3- History of trauma to skull and face
Intervention groups
Control group(11patients)is treated with Farmand appliance and intervention group(11patients),in addition to Farmand appliance, also receive laser irradiation.
Main outcome variables
More growth of mandible in laser group (increase of Co-Gn variable in laser group compared to Farmand group)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210221050435N1
Registration date:2021-04-04, 1400/01/15
Registration timing:registered_while_recruiting
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Hossein Aghili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1785
Email address
hosseinaghily@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low level laser in the treatment of class II patients with mandibular deficiency treated with Farmand functional appliance
Public title
The effect of low level laser on mandibular growth in patients treated with functional appliance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 10 to 13 years for girls and 11 to 14 years for boys
The patient profile in clinical view show the pattern of skeletal class II with mandibular deficiency so that the patient with retrognathic appearance has more acceptance profile after bringing the mandible forward.
The patient has dental canine and molar class II relationship
Exclusion criteria:
History of disease affected the growth process
History of jaw surgery
History of trauma to skull and face
Age
From 10 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
First, using Random allocation software version 1.0 under Windows ,we generate a random sequence using a simple random allocation method. In this table, it is specified from 1 to 22 and each number is assigned to an intervention group (A or B). The first eligible patient is assigned number 1, the second patient is assigned number 2 and so on up to 22 patients. In order to blind the random allocation of clients by a third person who is unaware of the interventions, they are placed in intervention groups (A or B) by this table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, patients are unaware of which group they are in (Farmand group or Farmand + laser group) because all patients, even those who does not include laser receiving, are in the same situation to receive the laser, except that we placed the applicator of laser in specific places, but without laser radiation.
In this study, with the exception of the laser device operator (who is aware of the laser irradiation or non-irradiation), the researcher (who is also responsible for treating the patients), the data collector, and the statistics consultant, who is responsible for analyzing the data, all are unaware of which group each patient belonged to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Yazd Shahid sadoughi University of medical science
Street address
central building of shahid sadoughi university of medical science and health services-Bahonar square-Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.SSU.REC.1398.025
Health conditions studied
1
Description of health condition studied
mandibular deficiency
ICD-10 code
M27.0
ICD-10 code description
Developmental disorders of jaws
Primary outcomes
1
Description
Increase rate of Co-Gn variable
Timepoint
Measurement of Co-Gn variable at the beginning of study (before the start of intervention) and after the end of functional appliance treatment period (after 6 months)
Method of measurement
Measurement on lateral cephalometric radiographs using a ruler and conveyor
2
Description
Increase rate of ANB variable
Timepoint
Measurement of ANB variable at the beginning of study (before the start of intervention) and after the end of functional appliance treatment period (after 6 months)
Method of measurement
Measurement on lateral cephalometric radiographs using a ruler and conveyor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the Farmand functional appliances are made for each patient, they are trained to use the appliance 24 hours a day, except when eating, exercising, and brushing. The laser used in this study is diode (GaA1As) (A.R.C. Laser, Deutschland, Nurberg) with a wavelength of 980 nm, the output power of 100 mw. After one month of using the appliance, until the end of treatment, once a week (12 sessions) laser with the above characteristics is irradiated. Radiation is performed accurately and continuously by contact method at 4 points around the temporomandibular joint (upper, anterior, posterior, posterior) and 100 seconds for each point.
Category
Treatment - Devices
2
Description
Control group: We place the patients in control group in the same conditions (constructing a functional appliance, training for use, starting treatment with a functional appliance and presence at laser treatment sessions) with the difference that we place only the laser applicator in the mentioned points but without laser radiation.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, School of Dentistry, Shahid Sadoughi University of Medical Sciences, Yaz
Full name of responsible person
Hossein agha Aghili
Street address
The beginning of Deh Fajr Boulevard, Imam Khomeini St
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
pajoheshdentyazd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masoud Mirzaei
Street address
The headquarters of Shahid Sadoughi University of Medical Sciences and Health Services, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
dvc.research@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/index.aspx?lang=1&sub=21
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hossein agha Aghili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, The beginning of Dahe Fajr Boulevard, Imam Khomeini St, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
hosseinaghily@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossein Aghili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid sadoughi university of medical sciences .school of dentistry.orthodontics dept
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3824 1785
Fax
Email
Hosseinaghily@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossein Aghili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid sadoughi university of medical sciences .school of dentistry.orthodontics dept
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3824 1785
Fax
Email
Hosseinaghily@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
after unidentifying, It is possible to share all lateral cephalometric variables of patients before and after treatment.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions and valid scientific research journals
Under which criteria data/document could be used
In order to use the documents of this study for other studies and researches to apply the results
From where data/document is obtainable
Responsible person in this field: Mohadeseh Sharifi , email address: Sharifimohadeseh@yahoo.com
What processes are involved for a request to access data/document
The applicant can send his request to the above-mentioned email address with his introduction and the reason for the request and receive the information as soon as possible (finally within 7-10 days).