search
Back to results

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
College of Medical Sciences Teaching Hospital. Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decayed Teeth focused on measuring decayed teeth; autotransplantation; 3d printing

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. patient presenting with decayed first molars
  2. autotransplantation of third molar at the recipient site

Exclusion Criteria:

  1. Diabetic, pregnant patients
  2. 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

    First Posted
    June 17, 2021
    Last Updated
    September 2, 2021
    Sponsor
    College of Medical Sciences Teaching Hospital. Nepal
    search

    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

    We'll reach out to this number within 24 hrs