3D Printed Donor Tooth Replica in Autotransplantation of Teeth

Decayed Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04933409
• Other study ID #: IOM1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2021
• Source: College of Medical Sciences Teaching Hospital. Nepal
• Contact: Ashutosh K Singh, MDS
• Phone: +9779804244369
• Email: dr.ashutosh[@]iom.edu.np
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Decayed Teeth
• Dental Caries

Intervention

Procedure:
• 3D printed replica of the donor tooth
3D printed replica of the donor tooth.
• Conventional Autotransplantation of tooth
Conventional Autotransplantation of tooth without using the 3D printed guide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
College of Medical Sciences Teaching Hospital. Nepal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of teeth that fail	reduced mobility (less than grade II) after 2 weeks of autotransplantation	two weeks
Primary	Operative time	Operative time from the start of socket preparation at the recipient site	1 day
Primary	Rate of Ankylosis (replacement resorption)	Ankylosis (replacement resorption)	6 months
Primary	Rate of root resorption	infection related root resorption	6 months
Secondary	Cost difference of the treatment	Cost of 3D printing	1 day