The effectiveness of school orthodontic screening, specific referral letter and orthodontic advice on treatment rate in patients who need timely treatment: a cluster-randomized controlled trial
Evaluating the effectiveness of school orthodontic screening, specific referral letter and orthodontic consultation on treatment rate in patients who need timely treatment
Design
Cluster-randomized controlled trial, parallel group with 198 patients in each group.
Stratified randomization is done. The unit of randomization is the school(cluster).
Settings and conduct
Second grade students(in gorgan, Aqqala, Kordkuy and Bandar-e-Gaz) with reversed overjet, one or two anterior teeth crossbite, and/or posterior crossbite and Fifth grade students with increased overjet (more than 6mm), one or two anterior teeth crossbite, and/or posterior crossbite will be examined. In intervention group orthodontic screening along with specific referral and orthodontic consultation will be done. in control group no intervention will be done after examination for 6 month. attendance at orthodontist will be compared after 6 month.
Three last year dentistry students who perform orthodontic school screening are kept blind. intervention will be done the day after screening by independent person. Data analyst is kept blind to the allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All elementary schools in Gorgan, Aqqala, Kordkuy and Bandar-e-Gaz
Second grade students with reversed overjet, one or two anterior teeth crossbite, and/or posterior crossbite
Fifth grade students with increased overjet (more than 6mm), one or two anterior teeth crossbite, and/or posterior crossbite
Exclusion criteria:
Schools does not agree to participate in the study
Children who refuse to be examined
Parents refusal to give informed consent
Intervention groups
Intervention group: screening in schools along with specific referral letter and orthodontic consultation
Control group: Without orthodontic screening, specific referral letter and orthodontic consultation
Main outcome variables
attendance at orthodontist
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240119060731N1
Registration date:2024-02-12, 1402/11/23
Registration timing:prospective
Last update:2024-02-12, 1402/11/23
Update count:0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
Mohammad Damavandi Kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 375 8032
Email address
dr.damavandi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of school orthodontic screening, specific referral letter and orthodontic advice on treatment rate in patients who need timely treatment: a cluster-randomized controlled trial
Public title
The effectiveness of school orthodontic screening, specific referral letter and orthodontic advice on treatment rate in patients who need timely treatment
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All elementary schools in Gorgan, Aqqala, Kordkuy and Bandar-e-Gaz
Second grade students with reversed overjet, one or two anterior teeth crossbite, and/or posterior crossbite
Fifth grade students with increased overjet (more than 6mm), one or two anterior teeth crossbite, and/or posterior crossbite
Exclusion criteria:
Schools does not agree to participate in the study
Children who refuse to be examined
Parents refusal to give informed consent
Age
From 7 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
396
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization is done by gender, type of school and city
The unit of randomization is the school (cluster)
Allocation concealment will be achieved with sequentially numbered, opaque, sealed envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
Three last year dentistry students who perform orthodontic school screening are kept blind. intervention will be done after screening by independent person.
Data analyst is kept blind to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
shahriar town
City
Gorgan
Province
Golestan
Postal code
4881844999
Approval date
2023-09-26, 1402/07/04
Ethics committee reference number
IR.GOUMS.REC.1402.266
Health conditions studied
1
Description of health condition studied
timely treatment of patients in need of orthodontic treatment
ICD-10 code
K07.2
ICD-10 code description
Anomalies of dental arch relationship
Primary outcomes
1
Description
attendance at orthodontist
Timepoint
6 month after intervention
Method of measurement
parents complete a survey which inquired whether they took the child to the orthodontist
Secondary outcomes
1
Description
Commencing orthodontic treatment
Timepoint
6 months after intervention
Method of measurement
parents complete a survey which inquired whether orthodontic treatment has been commenced
Intervention groups
1
Description
Intervention group: screening in schools along with specific referral letter and orthodontic consultation. In this group of patients, orthodontic problems are diagnosed, and the referral letter (includes an explanation of the type of problem, the right time for treatment, and by whom they should be treated will be given to them ). Moreover, they are invited to visit the Faculty of Dentistry for orthodontic consultation.
Category
Early detection
2
Description
Control group: Without screening, specific referral letter and orthodontic consultation. In this group of patients, orthodontic problems are diagnosed and no other intervention will be done for 6 month
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
elementary schools in Gorgan, Aqqala, Kordkuy and Bandar-e-Gaz
Full name of responsible person
Mohammad Damavandi Kamali
Street address
Unit 17, 2nd floor, Yademan building, Edalat Alley 21, Valiasr street
City
Gorgan
Province
Golestan
Postal code
4917748855
Phone
+98 17 3232 7923
Email
dr.damavandi@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beigom Mirbehbahani
Street address
Central organization of Golestan university of medical sciences, Hirkan BLVD
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Damavandi Kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 17, 2nd floor, Yademan building, Edalat Alley 21, Valiasr street
City
Gorgan
Province
Golestan
Postal code
4917748855
Phone
+98 17 3232 7923
Email
dr.damavandi@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Damavandi Kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 17, 2nd floor, Yademan building, Edalat Alley 21, Valiasr street
City
Gorgan
Province
Golestan
Postal code
4917748855
Phone
009832327923
Email
dr.damavandi@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Damavandi Kamali
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 17, 2nd floor, Yademan building, Edalat Alley 21, Valiasr street
City
Gorgan
Province
Golestan
Postal code
4917748855
Phone
+98 17 3232 7923
Email
dr.damavandi@goums.ac.ir
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