Comparison of the amount of vertical bone resorption by allograft and xenograft after extraction of maxillary anterior teeth with socket preservation technique
Comparison of the amount of vertical bone resorption by allograft and xenograft after extraction of maxillary anterior teeth with socket preservation technique
Design
The triple-blind, non-randomized clinical trial, on 15 patients.
Settings and conduct
The teeth will be extracted by an oral and maxillofacial surgeon in the department of oral and maxillofacial surgery of dental Faculty of Alborz University of Medical Sciences. This study is triple blind, so that neither the patient, nor the surgeon, nor the radiologist who examines the degree of bone resorption will know the allocation of the graft material to the tooth socket.
After preparing the CBCT radiograph, the sockets will be grafted with grafting material together with absorbable membranes and the dental sockets will be sutured. Then, before the implant surgery, CBCT imaging of the patients will be prepared again and the software of Technical University (MaZda Poland, Electronics of Institute, Lodz) will be used to review all the images obtained in the axial section.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patient over 18 years of age.
Non-inclusion criteria: patient with systemic disease; smokers; patients with periodontitis in the site of extraction.
Intervention groups
Intervention group: anterior teeth on the right side of the maxilla; Allograft bone powder is used in the intervention group.
Control group: anterior teeth on the left side of the maxilla; Xenograft bone powder is used in the control group.
Main outcome variables
Bone resorption amount after extraction of tooth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230215057429N1
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Armin Yazdanparast
Name of organization / entity
Alborz university of medical science- School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 1769
Email address
armin.yazdanparast@icloud.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the amount of vertical bone resorption by allograft and xenograft after extraction of maxillary anterior teeth with socket preservation technique
Public title
The effect of bone grafting in reducing bone loss after tooth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have both similar maxillary anterior teeth in their oral cavity and have referred to remove both teeth
Being at the age of 18 years and older
Exclusion criteria:
Smoker patient
Periodontitis in the anterior of maxilla
Infection after tooth extraction
Patients with periodontitis at the surgical site
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Two similar extracted teeth in each patient
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
The surgeon, patient and radiologist are not informed about the type of material used in filling the extracted tooth cavity by placing powders with the same appearance and amount in the same containers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Alborz University of Medical Sciences
Street address
Katooizade avenue, Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198684763
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.ABZUMS.REC.1402.011
Health conditions studied
1
Description of health condition studied
changes in height of upper jaw bone after tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
height of maxillary bone
Timepoint
1th and 180th day after intervention
Method of measurement
CBCT Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: upper right anterior teeth; The tooth socket preservation technique is used for the study; Allograft produced by Iranian tissue company is used as bone powder. The dosage used of the powder depends on the patient's dental socket
Category
Treatment - Surgery
2
Description
Control group: upper left anterior teeth; The socket preservation technique is used for the study; xenograft produced by Novatab company is used as bone powder. The dosage of the powder depends on the patient's dental socket.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School; Alborz University of Medical Sciences
Full name of responsible person
Armin Yazdanparast
Street address
No. 16, 5th west alley; Morvarid avenue, Saadat-abad
City
Tehran
Province
Tehran
Postal code
1998745876
Phone
+98 21 2209 1769
Email
Armin.yazdanparast@icloud.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Arghavan Etebarian
Street address
No 16, 5th west alley, Morvarid ave, Saadatabad
City
Tehran
Province
Tehran
Postal code
1998745876
Phone
+98 21 2209 1769
Email
Armin.yazdanparast@icloud.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dental School; Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Armin Yazdanparast
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 16, 5th west alley; Morvarid avenue, Saadat-abad
City
Tehran
Province
Tehran
Postal code
1998745876
Phone
+98 21 2209 1769
Email
Armin.yazdanparast@icloud.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Armin Yazdanparast
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 16, 5th west alley; Morvarid avenue, Saadat-abad
City
tehran
Province
Tehran
Postal code
1998745876
Phone
+98 21 2209 1769
Email
Armin.yazdanparast@icloud.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Armin Yazdanparast
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 16, 5th west alley; Morvarid avenue, Saadat-abad
City
tehran
Province
Tehran
Postal code
1998745876
Phone
+98 21 2209 1769
Email
Armin.yazdanparast@icloud.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