3D Printed Donor Tooth Replica in Autotransplantation of Teeth
Primary Purpose
Decayed Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D printed replica of the donor tooth
Conventional Autotransplantation of tooth
Sponsored by
About this trial
This is an interventional treatment trial for Decayed Teeth focused on measuring decayed teeth; autotransplantation; 3d printing
Eligibility Criteria
Inclusion Criteria:
- patient presenting with decayed first molars
- autotransplantation of third molar at the recipient site
Exclusion Criteria:
- Diabetic, pregnant patients
- other autotransplantations (other than first molar recipient and third molar donor)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D printed replica of Donor tooth
Conventional
Arm Description
3D printed replica of Donor tooth
Conventional method of autotransplantation.
Outcomes
Primary Outcome Measures
Number of teeth that fail
reduced mobility (less than grade II) after 2 weeks of autotransplantation
Operative time
Operative time from the start of socket preparation at the recipient site
Rate of Ankylosis (replacement resorption)
Ankylosis (replacement resorption)
Rate of root resorption
infection related root resorption
Secondary Outcome Measures
Cost difference of the treatment
Cost of 3D printing
Full Information
NCT ID
NCT04933409
First Posted
June 17, 2021
Last Updated
September 2, 2021
Sponsor
College of Medical Sciences Teaching Hospital. Nepal
1. Study Identification
Unique Protocol Identification Number
NCT04933409
Brief Title
3D Printed Donor Tooth Replica in Autotransplantation of Teeth
Official Title
3D Printed Donor Tooth Replica in Autotransplantation of Teeth. A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
College of Medical Sciences Teaching Hospital. Nepal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate.
Detailed Description
This technique of autotransplantation has been innovated using 3-dimensional (3D) imaging and rapid prototyping.The use of a 3D-printed replica of the donor tooth is thought to minimize the risk of iatrogenic damage to the actual donor tooth. Nevertheless, no large prospective and comparative studies are available to assess the outcomes using these 3D techniques. Therefore, this study aimed to compare 3D printed replicas in autotransplantation of teeth, compared to the conventional technique. The present study will evaluate the feasibility, clinical satisfied accuracy, and stability of a novel approach for computer-aided autotransplantation of teeth. This new approach facilitated the surgical procedure and might be a viable and predictable method for autotransplantation of teeth.
Application of printed 3D replicas of transplanted teeth facilitates surgical preparation of the recipient site, shortens the extra-alveolar time, and reduces the minimum the number of attempts of the donor tooth insertion at the prepared socket. Their use can significantly decrease the risk of damage to the root surface of a transplant, thus increasing the chance of success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decayed Teeth
Keywords
decayed teeth; autotransplantation; 3d printing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled tria
Masking
Outcomes Assessor
Masking Description
The outcomes will be evaluated by a blinded researcher.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D printed replica of Donor tooth
Arm Type
Experimental
Arm Description
3D printed replica of Donor tooth
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional method of autotransplantation.
Intervention Type
Procedure
Intervention Name(s)
3D printed replica of the donor tooth
Intervention Description
3D printed replica of the donor tooth.
Intervention Type
Procedure
Intervention Name(s)
Conventional Autotransplantation of tooth
Intervention Description
Conventional Autotransplantation of tooth without using the 3D printed guide
Primary Outcome Measure Information:
Title
Number of teeth that fail
Description
reduced mobility (less than grade II) after 2 weeks of autotransplantation
Time Frame
two weeks
Title
Operative time
Description
Operative time from the start of socket preparation at the recipient site
Time Frame
1 day
Title
Rate of Ankylosis (replacement resorption)
Description
Ankylosis (replacement resorption)
Time Frame
6 months
Title
Rate of root resorption
Description
infection related root resorption
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost difference of the treatment
Description
Cost of 3D printing
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient presenting with decayed first molars
autotransplantation of third molar at the recipient site
Exclusion Criteria:
Diabetic, pregnant patients
other autotransplantations (other than first molar recipient and third molar donor)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashutosh K Singh, MDS
Phone
+9779804244369
Email
dr.ashutosh@iom.edu.np
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes, On request to the principal investigator.
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
On request to the principal investigator
Learn more about this trial
3D Printed Donor Tooth Replica in Autotransplantation of Teeth
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