Determining the rate of relapse after alignment & leveling in orthodontic patients treated with ultrasound compared to the control group
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized. on 60 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this research, 60 patients with class 1 problem with severe crowdingare selected. Patients should undergo fixed orthodontic treatment of both jaws with extraction of the first premolar tooth in both arches. Then the patients are randomly divided into two groups. All patients are molded with alginate at this stage (T0). Then one group is considered as the control group .In the second group, from twenty days before removing the arch wire, there is a low-intensity ultrasound with a frequency protocol of 1 MHz and an intensity of 100 mW/cm² and a duty cycle of 20% (in 1000 cycles per second, 200 us on and 800 us off), frequency 1 KHz And the time of 20 minutes is irradiated to the canine teeth and alveoli of this area in both jaws for 10 sessions in the middle of a day. After this two-month period, the upper and lower jaws are molded from the case and control groups. Molds are cast with orthodontic plaster and are considered as T1.
Participants/Inclusion and exclusion criteria
Patients with 1- systemic disease 2- improper oral hygiene 3- gingivitis or periodontal problems or deep caries that have spread to the cement enamel junction 4- taking drugs that affect bone metabolism such as drugs that prevent bone resorption 5- Conditions for which liposuction is contraindicated, such as (pregnancy, the presence of a malignant lesion in the irradiated area, etc.)
Intervention groups
In the intervention group, twenty days before removing the arch wire and after correcting the crowding, the patient is treated with ultrasonic waves.
Main outcome variables
crowding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221028056331N1
Registration date:2022-11-25, 1401/09/04
Registration timing:prospective
Last update:2022-11-25, 1401/09/04
Update count:0
Registration date
2022-11-25, 1401/09/04
Registrant information
Name
at-har nasseri mojarad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 5326
Email address
nasseri.mojarad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-08, 1401/09/17
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of ultrasound on prevention of relapse in severe crouding
Public title
Investigating the effect of ultrasound on prevention of relapse in severe crouding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 17-30 years old with severe crowding (more than 8 mm crowding) of two jaws have been subjected to fixed orthodontic treatment with the extraction of 4 first premolars of both jaws.
Absence of systemic disease
Proper oral hygiene
Not suffering from conditions for which liposuction is contraindicated, such as (pregnancy, the presence of a malignant lesion in the irradiated area, etc.)
Exclusion criteria:
Non-cooperation of the patient to attend at specified times
Gingivitis or periodontal problems or deep caries that have spread to the cement enamel junction
Taking drugs that affect bone metabolism, such as drugs that prevent bone resorption
Age
From 17 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was done using blocks of 4. For this purpose, we benefited from the PASS 11 software, and thus people were assigned to two groups of 30.
Blinding (investigator's opinion)
Double blinded
Blinding description
60 patients from the special clinic of Mashhad Faculty of Dentistry, who meet the conditions for entering the study, were included in the study with their consent and were randomly divided into two equal intervention and control groups. For patients in the intervention group, the device was used on, and for the control group, the device was turned off. Patients of both intervention and control groups, as well as the person analyzing the data, were blinded.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of mashhad university of medical science
Street address
vakil abad blv
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.021
Health conditions studied
1
Description of health condition studied
dental relaps
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
1- Width of intercanin2- Intermolar width3- Arch length4- Arch Circumference5-Modified Little's irregularity index
Timepoint
Before the intervention and two months after removing the archwires
Method of measurement
Scanning dental cassettes and analyzing irregularities with computer software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:irradiation of ultrasonic waves on the soft tissue of the lips and around of it
Category
Treatment - Devices
2
Description
Control group: using the device on the off mode
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
masshad special dental clinic
Full name of responsible person
athar nasseri mojarad
Street address
vakil abad Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۵۹
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
nasseri.mojarad@gmail.com
Web page address
https://dentistry.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دکتر آرزو جهان بین
Street address
vakil abad blv
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Fax
Email
mail.mums@ac.ir
Web page address
https://dentistry.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
vice chancellor for research of 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
athar nasseri mojarad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
vakil abad blv
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Email
nasseri.mojarad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
arezoo jahan bin
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
vakil abad blv
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Email
JahanbinA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
athar nasseri mojarad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
vakil abad blv
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Email
nasseri.mojarad@gmail.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
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