3D Printed Donor Tooth Replica in Autotransplantation of Teeth
1 other identifier
interventional
50
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
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
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedSeptember 5, 2021
September 1, 2021
2 months
June 17, 2021
September 2, 2021
Conditions
Keywords
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
EXPERIMENTAL3D printed replica of Donor tooth
Conventional
ACTIVE COMPARATORConventional method of autotransplantation.
Interventions
3D printed replica of the donor tooth.
Conventional Autotransplantation of tooth without using the 3D printed guide
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- 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
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 1 year
- Access Criteria
- On request to the principal investigator
Yes, On request to the principal investigator.