Tooth LossYATANCT07314580
Clinical and Radiological Evaluation of Dental Autotransplantation in the Anterior Region in Young Patients
An observational study of Tooth Loss and Tooth Injury, run by University of Barcelona at 1 site in Spain.
Trial summary
This study aims to evaluate the clinical, radiographic, functional, and patient-reported outcomes of premolar autotransplantation used to replace anterior maxillary teeth in young patients. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Tooth Loss, Tooth Injury
- What is being tested?
- Premolar Autotransplantation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Young patients aged 7 to 15 years requiring replacement of a maxillary anterior tooth with a premolar autotransplantation at Dental Esthetic BCN, an accredited CEIm-UB clinical center.
Who may be able to join
- Patients aged 7 to 15 years.
- ASA I classification.
- Loss or indication for extraction of a maxillary anterior tooth (teeth 12, 11, 21, or 22) due to trauma, resorption, or restorative reasons.
- Availability of a donor first or second premolar with root development between one-half and complete root length.
- Ability to complete at least 2 years of follow-up.
- Parent/guardian consent and minor assent obtained for prospective cases.
Who cannot join
- Patients older than 15 years.
- Severe systemic disease.
- Inability or unwillingness to attend scheduled follow-up visits.
- Lack of a suitable donor premolar.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Dental Esthetic BCN
Barcelona, Barcelons, 08034
Xavier Rodriguez Ciurana, PhD, +34 936404390, info@dentalestheticbcn.com
About this study
Official title: Clinical, Radiographic, Functional and Psychosocial Evaluation of Premolar Autotransplantation to the Anterior Maxillary Region in Young Patients: An Ambispective Observational Study
This study aims to evaluate the clinical, radiographic, functional, and patient-reported outcomes of premolar autotransplantation used to replace anterior maxillary teeth in young patients. The study has an ambispective observational design, including a retrospective cohort (patients treated between December 2019 and December 2025) and a prospective cohort (patients enrolled until December 2028).
Participants aged 7 to 15 years who received or will receive premolar autotransplantation to replace an anterior tooth will be followed clinically and radiographically for up to 5 years. Outcomes include tooth survival, periodontal and pulpal healing, root development, complications, orthodontic interactions, restorative needs, and patient satisfaction. The study seeks to identify prognostic factors and long-term success indicators for dental autotransplantation in growing patients.
Read the detailed description
Premolar autotransplantation is a biologically favorable treatment option for young patients who have lost an anterior maxillary tooth due to trauma, resorption, or restorative failure. This study evaluates outcomes of autotransplantation combining a retrospective cohort (patients treated from 2019 to 2025) and a prospective cohort (patients recruited until 2028). All procedures follow a standardized clinical protocol including digital planning with CBCT and STL models, 3D-printed donor tooth replicas, guided socket preparation when needed, atraumatic donor extraction, extraoral time under 5 minutes, and semirigid splinting.
Clinical and radiographic follow-ups occur at 1 week, 15 days, 1, 2, 3, 6, 9, and 12 months, and annually up to 5 years. Evaluations include mobility, sensitivity, percussion sound, periodontal measurements, gingival recession, root development (Moorrees stages), pulpal healing, and radiographic signs of complications such as resorption or ankylosis. Digital analysis of soft and hard tissues and esthetic outcomes is performed with STL models and CBCT when indicated.
The study also assesses the influence of orthodontic variables (previous treatment, appliance type, timing of movement after transplantation) and restorative parameters (reconstruction chronology). Patient-reported outcomes include satisfaction, esthetics, function, and oral health-related quality of life using validated questionnaires.
Data from both cohorts are anonymized and analyzed descriptively and comparatively, with multivariable modeling to identify prognostic factors.
Although enrollment is defined at the participant level, outcome measures are assessed at the level of the autotransplanted tooth. Participants may contribute more than one autotransplanted tooth to the analysis.
The study will provide long-term evidence regarding success, survival, complications, and perceived outcomes of premolar autotransplantation in growing patients.
- Conditions
- Tooth Loss, Tooth Injury
- Being tested
- Premolar Autotransplantation
- Keywords
- autotransplantation, tooth autotransplant, premolar donor tooth, anterior maxilla, young patients, root development, CBCT, digital planning, guided surgery, orthodontics, periodontal healing, pulpal healing, traumatic tooth loss, avulsion injuries, trauma-related anterior tooth loss, Dental autotransplantation, Anterior maxillary tooth loss, tooth root development
- Medical subject headings
- Tooth Loss, Tooth Injuries, Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premolar AutotransplantationProcedure or surgery
Also called Tooth Autotransplantation, Dental Autotransplantation
Premolar autotransplantation performed using a standardized clinical protocol including digital planning (CBCT and STL models), 3D-printed donor tooth replicas, guided or conventional socket preparation, atraumatic donor extraction, extraoral time under 5 minutes and semirigid splinting. Clinical and radiographic follow-up is performed up to 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Autotransplantation Cohort | Young patients (7-15 years) who received or will receive premolar autotransplantation to replace an anterior maxillary tooth, following an identical standardized surgical, orthodontic, radiographic and follow-up protocol. Includes both retrospective and prospective participants. Receives: Procedure: Premolar Autotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Autotransplanted Teeth with Clinical and Radiographic Success
Number of autotransplanted teeth that fulfill all predefined success criteria at each follow-up visit:
Absence of ankylosis Absence of progressive root resorption Physiological mobility Normal percussion sound Functional stability Absence of clinical signs of infection Each autotransplanted tooth is considered an independent observational unit. In participants with more than one autotransplanted tooth, each tooth is evaluated separately.
Measured: Up to 5 years
Secondary outcomes (11)
Survival Rate of the Autotransplanted Tooth
Number of autotransplanted teeth remaining in situ without extraction during follow-up.
Measured: Up to 5 years
Root Development Stage of the Autotransplanted Tooth
Root development stage of the autotransplanted tooth assessed radiographically using the Moorrees classification.
Measured: Up to 5 years
Pulpal Healing Status of the Autotransplanted Tooth
Number of autotransplanted teeth presenting pulpal healing, defined as pulp canal obliteration or maintained pulp vitality without signs of necrosis, based on clinical testing and radiographic findings.
Measured: Up to 5 years
Periodontal Probing Depth of the Autotransplanted Tooth
Mean periodontal probing depth (in millimeters) measured at six sites around the autotransplanted tooth.
Measured: Up to 5 years
Gingival Recession of the Autotransplanted Tooth
Gingival recession measured in millimeters from the cemento-enamel junction to the gingival margin at the mid-buccal site of the autotransplanted tooth.
Measured: Up to 5 years
Incidence of Root Resorption
Number of autotransplanted teeth presenting inflammatory or replacement root resorption detected radiographically.
Measured: Up to 5 years
Incidence of Ankylosis
Number of autotransplanted teeth presenting clinical and/or radiographic signs of ankylosis.
Measured: Up to 5 years
Orthodontic Treatment After Autotransplantation
Time (in months) from autotransplantation to initiation of orthodontic tooth movement of the autotransplanted tooth.
Measured: Up to 5 years
Number of Restorative Procedures Performed on the Autotransplanted Tooth
Total number of restorative procedures performed on each autotransplanted tooth during follow-up.
Measured: Up to 5 years
Oral Health-Related Quality of Life (OHIP-14 Score)
Mean score of the Oral Health Impact Profile-14 (OHIP-14) questionnaire. Score range: 0-56. Higher scores indicate worse oral health-related quality of life.
Measured: Up to 5 years
Patient Satisfaction with Esthetic Outcome
Patient-reported satisfaction with dental esthetics measured using a Visual Analog Scale (VAS) from 0 to 10, where higher scores indicate greater satisfaction.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Dec 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MONTSERRAT MERCADE BELLIDO, University of Barcelona
- Investigators
- Montserrat Mercadé, PhD, Principal investigator, Dental Esthetic BCN / Universitat de BarcelonaJordi Cadellans, DDS, Principal investigator, Dental Esthetic BCN / Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314580
- Sponsor's protocol ID
- 63/2025-V3
- Other IDs
- 63/2025
- Acronym
- YATA
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared. This decision is based on European GDPR and Spanish data protection laws (LOPDGDD), as the study involves minors and identifiable clinical and radiographic information. Only aggregated, anonymized results will be published in scientific journals. No external researcher will have access to individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic, Functional and Psychosocial Evaluation of Premolar Autotransplantation to the Anterior Maxillary Region in Young Patients: An Ambispective Observational Study
- ClinicalTrials.gov ID
- NCT07314580
- Acronym / sponsor ID
- YATA / 63/2025-V3
- Conditions
- Tooth Loss, Tooth Injury
- Keywords
- autotransplantation, tooth autotransplant, premolar donor tooth, anterior maxilla, young patients, root development, CBCT, digital planning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the clinical, radiographic, functional, and patient-reported outcomes of premolar autotransplantation used to replace anterior maxillary teeth in young patients. The study has an ambispective observational design, including a retrospective cohort (patients treated between December 2019 and December 2025) and a prospective cohort (patients enrolled until December 2028).
Participants aged 7 to 15 years who received or will receive premolar autotransplantation to replace an anterior tooth will be followed clinically and radiographically for up to 5 years. Outcomes include tooth survival, periodontal and pulpal healing, root development, complications, orthodontic interactions, restorative needs, and patient satisfaction. The study seeks to identify prognostic factors and long-term success indicators for dental autotransplantation in growing patients.
Detailed description
Premolar autotransplantation is a biologically favorable treatment option for young patients who have lost an anterior maxillary tooth due to trauma, resorption, or restorative failure. This study evaluates outcomes of autotransplantation combining a retrospective cohort (patients treated from 2019 to 2025) and a prospective cohort (patients recruited until 2028). All procedures follow a standardized clinical protocol including digital planning with CBCT and STL models, 3D-printed donor tooth replicas, guided socket preparation when needed, atraumatic donor extraction, extraoral time under 5 minutes, and semirigid splinting.
Clinical and radiographic follow-ups occur at 1 week, 15 days, 1, 2, 3, 6, 9, and 12 months, and annually up to 5 years. Evaluations include mobility, sensitivity, percussion sound, periodontal measurements, gingival recession, root development (Moorrees stages), pulpal healing, and radiographic signs of complications such as resorption or ankylosis. Digital analysis of soft and hard tissues and esthetic outcomes is performed with STL models and CBCT when indicated.
The study also assesses the influence of orthodontic variables (previous treatment, appliance type, timing of movement after transplantation) and restorative parameters (reconstruction chronology). Patient-reported outcomes include satisfaction, esthetics, function, and oral health-related quality of life using validated questionnaires.
Data from both cohorts are anonymized and analyzed descriptively and comparatively, with multivariable modeling to identify prognostic factors.
Although enrollment is defined at the participant level, outcome measures are assessed at the level of the autotransplanted tooth. Participants may contribute more than one autotransplanted tooth to the analysis.
The study will provide long-term evidence regarding success, survival, complications, and perceived outcomes of premolar autotransplantation in growing patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autotransplantation Cohort | – | Procedure: Premolar AutotransplantationYoung patients (7-15 years) who received or will receive premolar autotransplantation to replace an anterior maxillary tooth, following an identical standardized surgical, orthodontic, radiographic and follow-up protocol. Includes both retrospective and prospective participants. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young patients aged 7 to 15 years requiring replacement of a maxillary anterior tooth with a premolar autotransplantation at Dental Esthetic BCN, an accredited CEIm-UB clinical center.
Key inclusion criteria (6 listed)
- Patients aged 7 to 15 years.
- ASA I classification.
- Loss or indication for extraction of a maxillary anterior tooth (teeth 12, 11, 21, or 22) due to trauma, resorption, or restorative reasons.
- Availability of a donor first or second premolar with root development between one-half and complete root length.
- Ability to complete at least 2 years of follow-up.
Key exclusion criteria (4 listed)
- Patients older than 15 years.
- Severe systemic disease.
- Inability or unwillingness to attend scheduled follow-up visits.
- Lack of a suitable donor premolar.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Premolar AutotransplantationAlso: Tooth Autotransplantation, Dental AutotransplantationPremolar autotransplantation performed using a standardized clinical protocol including digital planning (CBCT and STL models), 3D-printed donor tooth replicas, guided or conventional socket preparation, atraumatic donor extraction, extraoral time under 5 minutes and semirigid splinting. Clinical and radiographic follow-up is performed up to 5 years. | Procedure or surgery | Autotransplantation Cohort |
Primary outcome
Number of Autotransplanted Teeth with Clinical and Radiographic Success
Time frame: Up to 5 years
Number of autotransplanted teeth that fulfill all predefined success criteria at each follow-up visit: Absence of ankylosis Absence of progressive root resorption Physiological mobility Normal percussion sound Functional stability Absence of clinical signs of infection Each autotransplanted tooth is considered an independent observational unit. In participants with more than one autotransplanted tooth, each tooth is evaluated separately.
11 secondary outcomes
Survival Rate of the Autotransplanted Tooth
Time frame: Up to 5 years
Root Development Stage of the Autotransplanted Tooth
Time frame: Up to 5 years
Pulpal Healing Status of the Autotransplanted Tooth
Time frame: Up to 5 years
Periodontal Probing Depth of the Autotransplanted Tooth
Time frame: Up to 5 years
Gingival Recession of the Autotransplanted Tooth
Time frame: Up to 5 years
Incidence of Root Resorption
Time frame: Up to 5 years
Incidence of Ankylosis
Time frame: Up to 5 years
Orthodontic Treatment After Autotransplantation
Time frame: Up to 5 years
Number of Restorative Procedures Performed on the Autotransplanted Tooth
Time frame: Up to 5 years
Oral Health-Related Quality of Life (OHIP-14 Score)
Time frame: Up to 5 years
Patient Satisfaction with Esthetic Outcome
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Dental Esthetic BCNLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared. This decision is based on European GDPR and Spanish data protection laws (LOPDGDD), as the study involves minors and identifiable clinical and radiographic information. Only aggregated, anonymized results will be published in scientific journals. No external researcher will have access to individual-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Montserrat Mercadé, PhD principal investigator
Dental Esthetic BCN / Universitat de Barcelona
Jordi Cadellans, DDS principal investigator
Dental Esthetic BCN / Universitat de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Tooth Injury, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Montserrat Mercadé, PhD (+34 934011235, montsemercade@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Autotransplanted Teeth with Clinical and Radiographic Success (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.