Evaluation of Texture analysis of Radiological Hard Tissue Changes after Tooth Extraction with Socket Preservation Surgery Using xenograft and Allograft
The purpose of this study is the radiological evaluation of the surgical site by the texture analysis technique in CBCT images prepared from patients with and without tooth preservation surgery before implant placement, to check the radiological parameters in the surgical site performed before the implant placement.
Design
The clinical trial is with parallel groups, double-blind, randomized, on 75 patients, and randomized function of Excel software was used for randomization.
Settings and conduct
The teeth will be extracted in the Department of Oral and Maxillofacial Surgery of Tabriz Faculty of Medical Sciences under the supervision of the relevant professor. After the measurements are completed, the teeth will either be without any manipulation or with grafting material along with non-absorbable membranes. then, before the implant surgery, CBCT imaging is prepared from the patients for pre-surgery examinations. to examine all the images obtained in the axial section, Mazda software will be used
Participants/Inclusion and exclusion criteria
Patients who need extraction of mandibular posterior teeth due to caries.
Intervention groups
1. Patients who are candidates for implant placement in the posterior region of the mandible 4 months after tooth extraction without surgical intervention .
2. Patients who need a socket preservation technique after tooth extraction and xenograft material will be used for placement in the socket and will return 4 months later for implant placement.
3. Patients who need a socket preservation technique after tooth extraction and Alugraft material will be used to place it in the socket and will return 4 months later for implant placement.
Main outcome variables
Investigating the radiological parameters of hard tissue changes in the surgical site performed before the implant according to the variables obtained from the texture analysis technique
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220317054321N1
Registration date:2022-12-05, 1401/09/14
Registration timing:prospective
Last update:2022-12-05, 1401/09/14
Update count:0
Registration date
2022-12-05, 1401/09/14
Registrant information
Name
Narges Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 1874
Email address
nargesbayat91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Texture analysis of Radiological Hard Tissue Changes after Tooth Extraction with Socket Preservation Surgery Using xenograft and Allograft
Public title
Evaluation of Texture analysis of Radiological Hard Tissue Changes after Tooth Extraction with Socket Preservation Surgery Using xenograft and Allograft
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need extraction of mandibular posterior teeth due to caries
Exclusion criteria:
cigarettes and tobacco usage
History of chemotherapy and radiotherapy
Patients with specific systemic conditions such as diabetes
Taking certain drugs, including corticosteroids and bisphosphonate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient is coded by the envelope given to him and randomization is done by the SPSS software randomizer.
Blinding (investigator's opinion)
Double blinded
Blinding description
The radiology resident will do the radiological examinations of the images under the supervision of the supervisor, and the way of blinding is such that none of the people in the stage of radiological examinations and also statistical examinations are aware of the type of preparation before implant placement.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Dneshgah Ave., faculty of dentistry
City
Tabriz
Postal code
5166614711
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.TBZMED.REC.1401.588
Health conditions studied
1
Description of health condition studied
Patients who need implant placement after tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The difference between the parameters obtained from Texture analysis of three studied groups
Timepoint
4 month after tooth extraction
Method of measurement
evaluation of parameters derived from Mazda software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who are candidates for implant placement in the posterior area of the lower jaw 4 months after tooth extraction without dental socket preservation surgery intervention.
Category
Diagnosis
2
Description
Intervention group: Patients who need socket preservation technique after tooth extraction and are from Xenograft material. It will be used for placement in the socket and after 4 months they will refer for placement of the implant.
Category
Diagnosis
3
Description
Intervention group: Patients who need a socket preservation technique after tooth extraction and Alograft material will be used for placement in the socket and 4 months later they will refer for implant placement.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university of medical sciences
Full name of responsible person
Narges Bayat
Street address
Daneshgah Ave., faculty of dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 919 547 0553
Email
nargesbayat91@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soudabe Kimiayi
Street address
Daneshgah Ave., faculty of dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 919 547 0553
Email
nargesbayat91@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Narges Bayat
Position
Oral and maxillofacial resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Daneshgah Ave., faculty of dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 919 547 0553
Email
nargesbayat91@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Narges Bayat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Daneshgah Ave., faculty of dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 919 547 0553
Email
nargesbayat91@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Narges Bayat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Daneshgah Ave., faculty of dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 919 547 0553
Email
nargesbayat91@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