NCT04933409

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

June 17, 2021

Last Update Submit

September 2, 2021

Conditions

Keywords

decayed teeth; autotransplantation; 3d printing

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Cost difference of the treatment

    1 day

Study Arms (2)

3D printed replica of Donor tooth

EXPERIMENTAL

3D printed replica of Donor tooth

Procedure: 3D printed replica of the donor tooth

Conventional

ACTIVE COMPARATOR

Conventional method of autotransplantation.

Procedure: Conventional Autotransplantation of tooth

Interventions

3D printed replica of the donor tooth.

3D printed replica of Donor tooth

Conventional Autotransplantation of tooth without using the 3D printed guide

Conventional

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patient presenting with decayed first molars
  • autotransplantation of third molar at the recipient site

You may not qualify if:

  • Diabetic, pregnant patients
  • other autotransplantations (other than first molar recipient and third molar donor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Ashutosh K Singh, MDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes will be evaluated by a blinded researcher.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel randomized controlled tria
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 21, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Yes, On request to the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1 year
Access Criteria
On request to the principal investigator