Forced eruption for surgical removal of impacted third molars close to the mandibular canal with temporary anchorage device on the ramus as a pilot study
Effectiveness of orthodontic extrusion of mandibular third molars teeth with orthodontic coil spring
Design
Phase one semi-experimental clinical trial study consisted of a group of 6 patients with mandibular impacted wisdom teeth and their selection is based on the risk of nerve injury in radiography and the effectiveness of orthodontic extrusion will be evaluated.
Settings and conduct
This study will be performed in the Department of Oral and Maxillofacial Surgery, school of Dentistry, University of Tehran. Surgery will be performed among patients candidates for mandibular third molar surgery in 2022 in two phases of orthodontic extrusion and extraction.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with mandibular wisdom teeth close to the mandibular nerve canal
Exclusion criteria:
The horizontally impacted third molars of the mandible
Patients over 30 or below 17 years of age
Existence of systemic diseases including hypertension and diabetes
Intervention groups
The study included a group of patients with mandibular impacted wisdom teeth that are in close to the inferior alveolar nerve that will extrude with orthodontic spring then will extract.
Main outcome variables
Effectivness of orthodontic extrusion of mandibular wisdom teeth close to the nerve canal using orthodontic springs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220428054691N1
Registration date:2022-10-01, 1401/07/09
Registration timing:prospective
Last update:2022-10-01, 1401/07/09
Update count:0
Registration date
2022-10-01, 1401/07/09
Registrant information
Name
Mohammad Nomani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8601 6797
Email address
nmohammad2009@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-24, 1401/08/02
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Forced eruption for surgical removal of impacted third molars close to the mandibular canal with temporary anchorage device on the ramus as a pilot study
Public title
Orthodontic extraction of lower wisdom teeth with risk of lower lip paresthesia in new method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patient with impacted third molars
Exclusion criteria:
The horizontally impacted third molars of the mandible
Patients over 30 or below 17 years old
Existence of systemic diseases including hypertension and diabetes
Age
From 17 years old to 30 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
N/A
Randomization description
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
Research Ethics Committee, School of Dentistry, Tehran University of Medical Sciences
Street address
Department of Oral and Maxillofacial Surgery ,School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14399-55991
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.009
Health conditions studied
1
Description of health condition studied
Mandibular impacted wisdom teeth have required extraction surgery with possibility of inferior alveolar nerve injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
distracting of the apex of the mandibular wisdom tooth from the inferior alveolar canal following orthodontic traction
Timepoint
One month after orthodontic extrution
Method of measurement
Cone beam computed tomography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Orthodontic traction on mandibular impacted wisdom teeth to separate from the inferior alveolar canal with orthodontic spring and wire nickel titanium and steel wire with a thickness of 0.4 mm that connects one end of the spring to the ramus of mandible and the other end of the spring to the impacted tooth. The duration of this force is one month.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral and Maxillofacial Surgery ,School of Dentistry, Tehran University of Medical Scie
Full name of responsible person
Mohammad Nomani
Street address
Department of Oral and Maxillofacial Surgery ,School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14399-55991
Phone
+98 21 8601 6797
Email
Nmohammad2009@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr, Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8899 2970
Fax
+98 21 8898 7382
Email
Afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Nomani
Position
Oral and maxillofacial surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery ,School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14399-55991
Phone
+98 21 8601 6797
Email
Nmohammad2009@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Nomani
Position
Oral and maxillofacial surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery ,School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14399-55991
Phone
+98 21 8601 6797
Fax
Email
Nmohammad2009@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Nomani
Position
Oral and maxillofacial surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery ,School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14399-55991
Phone
+98 21 8601 6797
Email
Nmohammad2009@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
All data is shareable
When the data will become available and for how long
All data is potentially shareable after unidentified patients
To whom data/document is available
All of people
Under which criteria data/document could be used
for surgical use are allowed
From where data/document is obtainable
Mohammad nomani
Phone number
What processes are involved for a request to access data/document