3D Printed Donor Tooth Replica in Autotransplantation of Teeth

3D Printed Donor Tooth Replica in Autotransplantation of Teeth. A Randomized Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Decayed Teeth
• Intervention / Treatment: Procedure: 3D printed replica of the donor tooth; Procedure: Conventional Autotransplantation of tooth

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashutosh K Singh, MDS; Phone Number: +9779804244369; Email: dr.ashutosh@iom.edu.np

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D printed replica of Donor tooth	Procedure: 3D printed replica of the donor tooth; 3D printed replica of the donor tooth.
Active Comparator: Conventional; Conventional method of autotransplantation.	Procedure: Conventional Autotransplantation of tooth; Conventional Autotransplantation of tooth without using the 3D printed guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of teeth that fail	reduced mobility (less than grade II) after 2 weeks of autotransplantation	two weeks
Operative time	Operative time from the start of socket preparation at the recipient site	1 day
Rate of Ankylosis (replacement resorption)	Ankylosis (replacement resorption)	6 months
Rate of root resorption	infection related root resorption	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost difference of the treatment	Cost of 3D printing	1 day

Collaborators and Investigators

• Sponsor: College of Medical Sciences Teaching Hospital. Nepal

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: decayed teeth; autotransplantation; 3d printing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: IOM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No