Use of 3D replicas as surgical guides for dental autotransplantation (movement of a tooth from one position to another)

ISRCTN	ISRCTN13563091
DOI	https://doi.org/10.1186/ISRCTN13563091
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	23.07.2022, Nr.6-1/08/12, RSU
Sponsor	Riga Stradiņš University
Funders	Rīgas Stradiņa Universitāte PhD minimal scholarship- 17-5/2022/13933, Horizon 2020 grant agreement No 857287

Submission date: 06/11/2022
Registration date: 30/11/2022
Last edited: 07/11/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Tooth loss is mainly solved by prosthetic rehabilitation or dental implants. However, these solutions are expensive and may not be affordable for the entire population. As a biological and less costly alternative, autotransplantation (i.e. using a tooth extracted from the same patient, usually a third molar, to replace a tooth that has to be extracted, usually due to tooth decay), has shown an effectiveness of 80-95%. One factor that explains the difference in survival of the auto-transplanted tooth is the time that elapses between when the tooth is extracted and re-implanted. Traditionally, when the tooth is extracted, it is used as a mould to adapt the bone site that will receive it. Adaptation of the receptor alveolus (tooth sockets) requires time and surgical skill. A surgical guide could reduce the surgical time and improve the survival results of the auto-transplanted tooth, considering that it would reduce the time it remains outside the socket. This study aims to explore the effect of using 3D replicas of the tooth to be auto-transplanted to reduce surgical time and improve the results of autotransplantation. For this purpose, a 3D cone-beam scanner is taken in selected patients to evaluate the anatomy of the tooth to be transplanted. A 3D model is then generated and printed, generating a replica that allows it to be used for the surgical adaptation or grinding of the recipient site without having to extract the donor tooth until the moment before the autotransplant, thus reducing the time it remains outside an alveolus.

Who can participate?
Patients under the age of 25 years who require the extraction of a permanent tooth, molar or premolar and who have at least one third molar

What does the study involve?
A surgeon will ask for a 3D scan of the patient's jaw to make a model of the tooth to be transplanted. Then, during the extraction of the decayed tooth, the model will be used to ensure that the self-transplanted third molar will fit snugly in place of the extracted tooth. Patients in the control group will receive conventional autotransplantation, i.e. without using a 3D replica. Each patient will be monitored at 6, 12 and 24 months.

What are the possible benefits and risks of participating?
Using one of the patient's teeth is cheaper and more biological than using dentures or dental implants. The expected adverse effects are failure of autotransplantation due to infection and pain after the surgery.

Where is the study run from?
Riga Stradins University (Latvia)

When is the study starting and how long is it expected to run for?
January 2019 to June 2026

Who is funding the study?
1. Riga Stradins University (Latvia)
2. Horizon 2020

Who is the main contact?
Dr Miks Lejnieks, Miks.Lejnieks@rsu.lv

Contact information

Mr Miks Lejnieks
Principal investigator

Department of Oral and Maxillofacial Surgery
Dzirciema iela 20
Riga
LV-1007
Latvia

ORCID ID	0000-0002-9903-9452
Phone	+371 (0)67455586
Email	Miks.Lejnieks@rsu.lv

Prof Ilze Akota
Principal investigator

Department of Oral and Maxillofacial Surgery
Dzirciema iela 20
Riga
LV-1007
Latvia

ORCID ID	0000-0003-2263-1383
Phone	+371 (0)67455586
Email	Ilze.Akota@rsu.lv

Prof Gundega Jākobsone
Scientific

Department of Orthodontics
Dzirciema iela 20
Riga
LV-1007
Latvia

ORCID ID	0000-0003-0509-1709
Phone	+371 (0)67455586
Email	gundega.jakobsone@rsu.lv

Prof Laura Neimane
Scientific

Department of Conservative Dentistry and Oral Health
Dzirciema iela 20
Riga
LV-1007
Latvia

ORCID ID	0000-0002-5411-5810
Phone	+371 (0)67455586
Email	laura.neimane@stomatologijasinstituts.lv

Prof Sergio Uribe
Scientific

Department of Conservative Dentistry and Oral Health
Dzirciema iela 20
Riga
LV-1007
Latvia

ORCID ID	0000-0003-0684-2025
Phone	+371 (0)67455586
Email	sergio.uribe@rsu.lv

Study information

Primary study design	Interventional
Study design	Non-randomized controlled clinical study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Effect of the use of 3D printed replicas on the surgical time of autotransplantation: a controlled clinical study
Study acronym	3DATT
Study objectives	Hypothesis 1: The use of 3D-printed replicas decreases operative surgical time during autotransplantation. Hypothesis 2: The use of 3D-printed replicas improves the survival of auto-transplanted teeth.
Ethics approval(s)	Approved 23/07/2022, Research Ethics Committees of Riga Stradins University (Rīga Stradiņš University Main Building, 16 Dzirciema iela, Rīga, LV-1007, Latvia; Tel: not available; pek@rsu.lv), ref: 6-1/08/12. The ethics committee's permission indicated the possibility of including patients as historical controls, so they included patients from August 2019 onwards.
Health condition(s) or problem(s) studied	Tooth extraction due to extensive tooth decay
Intervention	Patients assigned to the procedure will have a maxillary cone-beam CT radiographic examination. The third molar or tooth to be transplanted with the imaging volume will be modelled to create a 3D-printed model. Subsequently, during surgery, the affected tooth will be extracted and the 3D model will be used to adjust the socket to receive the tooth transplanted. Once the extracted tooth's socket is adapted, the tooth to be auto-transplanted will be extracted and proceed as usual. Patients in the control group will receive conventional autotransplantation, i.e. without using a 3D replica. Patient allocation will be sequential, not randomised, and the surgeon in charge will be aware of the group assigned to the patient (it will be unblinded). Each patient will be monitored at 6, 12 and 24 months.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Survival of the auto-transplanted tooth measured in months or years
Key secondary outcome measure(s)	1. Surgical time used, measured in minutes from the first incision to the end of the last suture 2. Donor extra alveolar socket time(s), measured in minutes. The extracted tooth was fitted into the recipient’s socket in the control group. For extra-alveolar time in the control group, only the time that it was outside the original socket was registered. 3. Donor fitting times, measured in minutes. Fitting into the recipient socket attempts was recorded. If the socket had to be adjusted, then extracted donor's tooth was gently replaced back in the original socket. 4. Success and survival rate at 1, 3, 6, 12 and 24 months after autotransplantation. Survival will be considered as the permanence of the auto-transplanted tooth, in the absence of infection or pain and with radiographic evidence of the absence of adjacent bone problems. 5. Infection/alveolitis rate, defined as the proportion of sites that had a clinical diagnosis of alveolitis after the surgery or required antibiotic therapy at any moment after the surgery 6. Any other adverse effects reported in addition to infection, swelling or pain at 6, 12 and 24 months
Completion date	01/06/2026

Eligibility

Participant type(s)	Patient
Age group	Mixed
Upper age limit	25 Years
Sex	All
Target sample size at registration	49
Total final enrolment	46
Key inclusion criteria	1. Patients under the age of 25 years 2. One or more missing teeth or irreversible dental damage 3. Seeking help at the RSU Institute of Stomatology for the restoration of dental row defects 4. Have indications for autotransplantation of third molars 5. Understand the nature of the procedure and give informed consent 6. The third molars have not erupted 7. Clinically healthy 8. Good oral hygiene 9. Non-smokers
Key exclusion criteria	1. Unsuccessful extraction of the donor's tooth 2. Insufficiently formed roots of third molars 3. Patients with chronic diseases 4. Pregnancy 5. The patient does not attend control visits
Date of first enrolment	14/08/2019
Date of final enrolment	01/06/2025

Locations

Countries of recruitment

Latvia

Study participating centre

RSU Stomatologijas Instituts

Dzirciema iela 20
Riga
LV-1007
Latvia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The data of the study will be published in the RSU data repository (https://dataverse.rsu.lv/). Access will be restricted. The name of the repository: RSU Dataverse A persistent weblink (if applicable): the final dataset has not yet been generated The type of data stored: the repository will contain a dataset with anonymised patient data in CSV format, the statistical analysis script in r format and the output of the statistical analysis in HTML format. The process for requesting access (if non-publicly available): the data will be made publicly available under CC Attribution 4.0 International (CC BY 4.0) license. Timing for availability: data expected to be available from January 2025 Whether consent from participants was required and obtained: all participants provided written consent to participate in the study. Comments on data anonymization: the data were anonymised using the R Anonymizer package (Paul Hendricks (2015). anonymizer: Anonymize Data Containing Personally Identifiable Information. R package version 0.2.0. https://github.com/paulhendricks/anonymizer). Only the principal investigator has access to the code that identifies each patient. Any ethical or legal restrictions: only those applicable to the CC Attribution 4.0 International (CC BY 4.0) licence.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/11/2023	02/11/2023	Yes	No
Results article		06/11/2024	07/11/2024	Yes	No
Dataset			05/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/11/2024: Publication reference added.
04/11/2024: Publication and dissemination plan updated.
02/11/2023: Publication reference and total final enrolment added.
05/06/2023: A link to the dataset was added.
10/11/2022: Trial's existence confirmed by the Research Ethics Committees of Riga Stradins University.