Determining the accuracy of the printed surgical guide of the tooth-tissue supported implant in the anterior and posterior regions of the maxilla and mandible.
Design
Randomized clinical trial non-blinded phase 2 control group on 52 patients.The rand function of Excel software was used for randomization
Settings and conduct
This study is conducted in Hamedan Dental Faculty.The ideal position of the implants is based on the position of the prosthesis and the bone position of the patient. After the final approval of the implant treatment plan, surgical guides are produced using 3D printers. The surgical guide is made by the printer and the implants are placed. Then we compare the accuracy of the implants with the initial ideal position.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients must be at least 18 years old, have good quality and quantity of bone
Exclusion criteria:
Pregnant women, smokers, People with systemic problems who cannot place implants
Intervention groups
The intervention group includes edentulous patients in Kennedy class 4 edentulous areas and Kennedy class 3 modifications, who must have 1 to 3 missing teeth in each edentulous area and receive implant treatment intervention by a surgical guide.
Control group: The ideal position of the implants is applied in the 3shape Implant Studio software based on the position of the prosthesis and the bone position of the patient.
Main outcome variables
Determining the accuracy of the surgical guide in the anterior maxilla, posterior maxilla, anterior mandible, posterior mandible areas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240223061089N1
Registration date:2024-03-28, 1403/01/09
Registration timing:retrospective
Last update:2024-03-28, 1403/01/09
Update count:0
Registration date
2024-03-28, 1403/01/09
Registrant information
Name
Zahra Khayami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 0000
Email address
zkhayami60@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Accuracy Comparison of 3D printed tooth-tissued supported implant surgical guides in anterior vs posterior site of maxilla and mandible
Public title
Accuracy Comparison of implant surgical guides
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be at least 18 years old
Have good bone quality and quantity
have a minimum bone depth of 5.8 mm to place each implant
Exclusion criteria:
pregnant women
smokers
People who needed Bone Augmentation at the same time
People undergoing radiotherapy
People taking bisphosphonates
People with uncontrolled diabetes
People with systemic problems involving bones
and people who have prohibitive mental problems
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
156
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
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan, Hamedan University of Medical Sciences, Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.UMSHA.REC.1402.559
Health conditions studied
1
Description of health condition studied
surgical guide of implant
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
The accuracy of the surgical guide
Timepoint
After implant placement
Method of measurement
3shape software
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: includes edentulous patients in Kennedy class 4 edentulous areas and Kennedy class 3 modifications, who must have 1 to 3 missing teeth in each edentulous area and receive implant treatment intervention by a surgical guide.
Category
Treatment - Surgery
2
Description
Control group: The ideal position of the implants is applied in the 3shape Implant Studio software based on the position of the prosthesis as well as the bone position of the patient.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Zahra khayami
Street address
shahid fahmide bvd, Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza shokoohi
Street address
Shahid Fahmideh Blvd., Central Headquarters of University of Medical Sciences,
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Khayami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Blvd., Pajoohesh Sq., Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Fax
Email
zkhayami60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Khayami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Blvd., Pajoohesh Sq., Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Fax
Email
zkhayami60@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Khayami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Blvd., Pajoohesh Sq., Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Fax
Email
zkhayami60@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD