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Assessment of the effectiveness of dental occlusion on postural position of body in students of semester 8 to semester 12 at Shahid Beheshti School of dentistry

Protocol summary

Study aim
The aim of this study was to asses the effects of occlusal splints on controlling the postural position of the body in students of semester 8 to semester 12 at Shahid Beheshti School of dentistry
Design
Clinical trial with control group, with parallel, non-blind, randomized groups, on 40 patients. Randomization.com website was used.
Settings and conduct
In this study, 40 volunteers with dental occlusion problems were examined in two groups of intervention and control (20 people in each group). First, using Alginate molding material, the impressions of upper and lower jaws were taken, and after recording the CR and face bow, the casts were mounted in a semi-adjustable articulator, and then a CR splint was made with transparent acrylic material based on patient’s centric realation. The Balance indicators was measured by Biodex device before the first session, after the first session and after one month.
Participants/Inclusion and exclusion criteria
The inclusion criteria included Non-compliance of the central relationship with the maximum intercuspation, the ability to walk at least 10 meters independently without the use of auxiliary equipment, having the ability to stand independently on the level 8 of Biodox balance device ; the exclusion criteria included having previous Neurological, Equilibrium and Labyrinth Diseases and having history of falling or fractures of the lower limbs in the last year
Intervention groups
The intervention group included those who received treatment for occlusal splints. This treatment, without any irreversible effect, leads the mandible to the position of the central relationship. The control group also included those who did not receive any treatment.
Main outcome variables
OSI, APSI and MLSI These indexes, measured by the Biodex device, are oscillation the center of gravity of the body relative to the zero point in different axes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200516047458N1
Registration date: 2020-06-17, 1399/03/28
Registration timing: retrospective

Last update: 2020-06-17, 1399/03/28
Update count: 0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
amirfarhang poureini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 8093
Email address
amirfarhang374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-23, 1397/12/04
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-02-25, 1397/12/06
Actual recruitment end date
2020-01-13, 1398/10/23
Trial completion date
2020-02-12, 1398/11/23
Scientific title
Assessment of the effectiveness of dental occlusion on postural position of body in students of semester 8 to semester 12 at Shahid Beheshti School of dentistry
Public title
Effect of dental occlusion on posture of the body
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-compliance of the central relationship with the maximum intercuspation Ability to walk at least 10 meters independently without the use of auxiliary devices Ability to stand independently on the highest level of stability of the Biodox device
Exclusion criteria:
Having a history of neurological disease, systemic disease, equilibrium or labyrinthine disease Having acute or major orthopedic problems, especially in the pelvis, lower limbs and spine Existence of acute uncorrected vision problems The presence of sensory disturbances or vascular pathology in the lower extremities Have a history of falling in the last year History of heart attack in the last 6 months History of fractures of the lower limbs in the last year
Age
From 22 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block randomization Randomization unit: individual Used the website https://www.Randomization.com 40 subjects randomized into 5 blocks. in order to reproduce this plan, used the seed 9580 . the number of subjects per block were 8 , number of blocks were 5 and treatment labels were case and control as entered originally.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Research Institute for Dental Sciences
Street address
5th Floor, Shahid Beheshti,Dental School, Evin, Tehran-IRAN
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.SBMU.DRC.REC.1398.023

Health conditions studied

1

Description of health condition studied
Occlusal problems
ICD-10 code
M26.69
ICD-10 code description
Other specified disorders of temporomandibular joint

Primary outcomes

1

Description
Medial-lateral stability index (MLSI)This number, calculated by the device, is the oscillation of the center of gravity of the body relative to the zero point on the medial-lateral axis. Naturally, the lower the number of index indicates the better the stability and lower postural deviation.
Timepoint
1. Before the intervention of the first session 2. After the intervention of the first session 3.One month after the first session
Method of measurement
The variable was collected by the Biodex system as a result of the sample performances.

2

Description
Anterior-posterior stability index (APSI)This number, calculated by the device, is the oscillation of the center of gravity of the body relative to the zero point on the anterior-posterior axis. Naturally, the lower the number of index indicates the better the stability and lower postural deviation.
Timepoint
1. Before the intervention of the first session 2. After the intervention of the first session 3.One month after the first session
Method of measurement
The variable was collected by the Biodex system as a result of the sample performances.

3

Description
Overall stability index (OSI)This number, calculated by the device, is the oscillation of the center of gravity of the body relative to the zero point on the overall axis. Naturally, the lower the number of index indicates the better the stability and lower postural deviation.
Timepoint
1. Before the intervention of the first session 2. After the intervention of the first session 3.One month after the first session
Method of measurement
The variable was collected by the Biodex system as a result of the sample performances.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Those who have received occlusal splint treatment. Occlusal splint is a prosthetic appliance that is made using transparent acrylic (made in Acropars Factory, Iran) in the laboratory. This device directs the mandible to the centric jaw position.All samples in this group use this occlusal splint for one month.
Category
Treatment - Devices

2

Description
Control group: Those who have not received any treatment. The members of this group only participate in the balance study sessions with the other group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti university of medical sciences and health services , school of dentistry
Full name of responsible person
Yeganeh Memari
Street address
Shahid Beheshti university of medical sciences,School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3075
Email
DentIt@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Mahmood Khodadoost
Street address
5th Floor, Bldg No.1 Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9892
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Majid Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti university of medical sciences,School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
majidhosseini44@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Majid Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti university of medical sciences,School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
majidhosseini44@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Majid Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti university of medical sciences,School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
majidhosseini44@yahoo.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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