Comparing the panoramic and CBCT imaging efficacy in reducing nerve injury and providing appropriate diagnostic information and surgical planning for removal of the impacted lower third molars with intimate nerve proximity: a radiographic and clinical study
Comparing the panoramic and CBCT imaging efficacy in reducing nerve injury and providing appropriate diagnostic information and surgical planning for the removal of the impacted lower third molars with intimate nerve proximity In the candidates for this surgery that referred to the Department of Oral, Maxillofacial Surgery, JundiShapur Dental Faculty, Ahvaz and a private center in Khuzestan.
Design
A clinical trial with a single control group, unblinded; simple randomization; each group has 129 patients.
Settings and conduct
This study will be conducted in the field of wisdom tooth surgery at Jundishapur Dental School of Ahvaz and a private center in Khuzestan, Iran. After clinical and radiographic examination, the treatment plan will be presented and based on a minimally invasive approach. The desired tooth extraction surgery will be performed and the desired parameters will be checked (The case and control group were chosen randomly).
Participants/Inclusion and exclusion criteria
Entry/Not-entry conditions:
The presence of a hidden third molar of the lower jaw that needs to be removed; Having radiographic signs of root bresoimposition on the canal.
The presence of an underlying disease; The use of drugs that interferes with wound healing; pathological condition in the area; Absence of adjacent second molar; local inflammation; Neurological sensory changes before surgery; Reluctance to obtain CBCT
Intervention groups
The surgical technique will be based on the PAN or CBCT images:
The need to section the crown
Root sectioning
The possibility of safe bone removal on the buccal or lingual side
Tooth or root extraction route
How close the nerve is to the roots
Risk areas in surgery
Main outcome variables
Inferior alveolar nerve damage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230313057705N1
Registration date:2023-04-08, 1402/01/19
Registration timing:registered_while_recruiting
Last update:2023-04-08, 1402/01/19
Update count:0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Kazem Khiabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5169
Email address
khiabani-k@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the panoramic and CBCT imaging efficacy in reducing nerve injury and providing appropriate diagnostic information and surgical planning for removal of the impacted lower third molars with intimate nerve proximity: a radiographic and clinical study
Public title
Comparing the efficiency of panoramic and CBCT in mandibular impacted wisdom tooth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of at least one impacted mandibular third molar that needs to be extracted
Having radiographic signs of superimposition of the root on the canal (at least half the height of the canal) or the presence of at least one of the classic signs of involvement of the third molar with the IAC in PAN or the contact of the nerve and the underlying tooth (crown or root) in a long path with the nerve and root (like a tooth lying on a nerve).
Exclusion criteria:
The presence of any systemic disease
Use of medications that can interfere with the immune response or wound healing after surgery
Existence of a pathological condition in the third molar area
Absence of adjacent second molar
Local inflammation or perichronitis associated with the third molar during extraction
Presence of neurosensory changes before the operation
Reluctance to obtain CBCT
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
258
Randomization (investigator's opinion)
Randomized
Randomization description
Each person's information (including the image file) is placed in a "sealed envelope". Patients are "sequentially" and based on "simple randomization" directed to two groups, PAN and CBCT.
Sampling will continue until the list of the number of people in both groups is complete.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Esfand Ave - Farvardin Blvd - Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.AJUMS.REC.1401.576
Health conditions studied
1
Description of health condition studied
Impacted lower third molar surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Inferior alveolar nerve damage
Timepoint
7th day and 1st, 3rd and 6th months after surgery
Method of measurement
1. 2-point discrimination (TPD) It measures the minimum distance that the patient can distinguish between two separate points.This test is done using a caliper and the result will be recorded numerically in millimeters. 2. Pin test: it will be done by touching the skin with a sharp needle to test the perception of pain (the needle is applied to the skin using its own weight).3. Light touch test: A cotton brush is used to test the tactile stimulation by gently touching the skin and the patient's detection threshold is evaluated.
Secondary outcomes
1
Description
Diagnostic efficiency during surgery
Timepoint
At the beginning of the study
Method of measurement
Based on points earned
2
Description
Surgical treatment plan efficiency
Timepoint
During surgery
Method of measurement
Based on points earned
3
Description
Mental comfort of the surgeon during surgery
Timepoint
During surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The CBCT group; in which the type of intervention is in the form of having CBCT imaging and diagnostic information and details obtained from it, which the surgeon uses to perform the surgery.
Category
Diagnosis
2
Description
Control group: It is the PAN group. ]n which there are basic diagnostic information and details obtained from panoramic imaging and the surgical process will be done based on it.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kazem Savojbolaghchi Khiabani
Street address
Dey Ave, Farvardin Blvd, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 5169
Email
khiabani-k@ajums.ac.ir
2
Recruitment center
Name of recruitment center
A private oral and maxillofacial surgery center
Full name of responsible person
Kazem Savojbolaghchi Khiabani
Street address
Keyhan building - Shahriyar Ave - Amiri Blvd
City
Abadan
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 5323 0776
Email
khiabani-k@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Esfand Ave - Farvardin Blvd - Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty members grant
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
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Khiabani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dental Medicine, Dey Ave., Farvardin Blvd., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 5169
Fax
Email
khiabani-k@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Khiabani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dental Medicine, Dey Ave., Farvardin Blvd., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 5169
Fax
Email
khiabani-k@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Khiabani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dental Medicine, Dey Ave., Farvardin Blvd., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 5169
Fax
Email
khiabani-k@ajums.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
No - There is not 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