3D Printed Donor Tooth Replica in Autotransplantation of Teeth

Sponsor

College of Medical Sciences Teaching Hospital. Nepal (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04933409

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Decayed Teeth	Procedure: 3D printed replica of the donor tooth Procedure: Conventional Autotransplantation of tooth	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel randomized controlled triaParallel randomized controlled tria

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcomes will be evaluated by a blinded researcher.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D printed replica of Donor tooth 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

Arm

Intervention/Treatment

Experimental: 3D printed replica of Donor tooth

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Cost difference of the treatment [1 day]
Cost of 3D printing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

College of Medical Sciences Teaching Hospital. Nepal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ashutosh Kumar Singh, Assistant Professor, College of Medical Sciences Teaching Hospital. Nepal

ClinicalTrials.gov Identifier:

NCT04933409

Other Study ID Numbers:

IOM1

First Posted:

Jun 21, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ashutosh Kumar Singh, Assistant Professor, College of Medical Sciences Teaching Hospital. Nepal

decayed teeth; autotransplantation; 3d printing

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Sep 5, 2021