A clinical trial to compare the effectiveness of ultrasonic surgery with conventional technique on movement speed and position of exposed teeth in patients with palatally impacted maxillary canines
To compare the effectiveness of ultrasonic surgery with conventional technique on movement speed and position of exposed teeth in patients with palatally impacted maxillary canines
Design
This randomized and double-blind clinical trial with parallel and control groups will be conducted on 20 patients who will be randomly selected using the blocks.
Settings and conduct
Patients with palatally impacted maxillary canines referring to Dental Clinic of Birjand Faculty of Dentistry, Birjand, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the ultrasonic surgery and control group will receive conventional technique. The care provider and responsible for data collection are blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 12-35 years; having unilateral palatal canine; no having history of orthodontic treatment; no having history of trauma in the jaw and face area; no having surgical interventions in the head and face area; no use of drugs that affect tooth movement; having good oral hygiene; no history of tooth extraction in the previous two months.
Exclusion criteria: Having congenital syndrome or cleft lip and palate; having systemic disease that affects tooth movement; having periodontal problems.
Intervention groups
The intervention group, after aligning the teeth and creating space with a spring opener, the latent canine tooth will be exposed using the scalpel method of the Woodpecker Piezosurgery device.
The control group, after aligning the teeth and creating space with a spring opener, the latent canine tooth will be exposed using the conventional milling method.
Main outcome variables
Evaluation of the amount of angle and position of the hidden tooth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230602058366N2
Registration date:2023-11-18, 1402/08/27
Registration timing:prospective
Last update:2023-11-18, 1402/08/27
Update count:0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Majid Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 3002
Email address
azizi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of ultrasonic surgery with conventional technique on movement speed and position of exposed teeth in patients with palatally impacted maxillary canines
Public title
The effectiveness of ultrasonic surgery on movement speed and position of exposed teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 12-35 years
Having unilateral palatal canine
No having history of orthodontic treatment
No having history of trauma in the jaw and face area
No having surgical interventions in the head and face area
No use of drugs that affect tooth movement
No history of tooth extraction in the previous two months
Having good oral hygiene
Exclusion criteria:
Having congenital syndrome or cleft lip and palate
Having systemic disease that affects tooth movement
Having periodontal problems
Age
From 12 years old to 35 years old
Gender
Both
Phase
1-2
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be simple randomly assigned to two groups using the blocks and opaque envelopes will be used for concealment
Blinding (investigator's opinion)
Double blinded
Blinding description
The care provider and responsible for data collection are blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.BUMS.REC.1402.299
Health conditions studied
1
Description of health condition studied
Palatally impacted maxillary canines
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
The amount of angle of the hidden tooth
Timepoint
Two months after intervention
Method of measurement
Based on orthopantomography (OPG) images
2
Description
The position of the hidden tooth
Timepoint
Two months after intervention
Method of measurement
Based on orthopantomography (OPG) images
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group, after aligning the teeth and creating space with a spring opener, the latent canine tooth will be exposed using the scalpel method of the Woodpecker Piezosurgery device.
Category
Treatment - Devices
2
Description
Control group: The control group, after aligning the teeth and creating space with a spring opener, the latent canine tooth will be exposed using the conventional milling method.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Birjand Faculty of Dentistry
Full name of responsible person
Majid Azizi
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Majid Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Majid Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Majid Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Web page address
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Majid Azizi provides the data analysis to the applicants via email: majid_67_a@yahoo.com
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.