Clinical and Radiological Evaluation of Dental Autotransplantation in the Anterior Region in Young Patients (YATA)

December 17, 2025 updated by: MONTSERRAT MERCADE BELLIDO, University of Barcelona

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.

Study Overview

Status

Recruiting

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Barcelons
      • Barcelona, Barcelons, Spain, 08034
        • Recruiting
        • Dental Esthetic BCN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients older than 15 years.
  • Severe systemic disease.
  • Inability or unwillingness to attend scheduled follow-up visits.
  • Lack of a suitable donor premolar.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Tooth Autotransplantation
  • Dental Autotransplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate of the Autotransplanted Tooth
Time Frame: Up to 5 years
Number of autotransplanted teeth remaining in situ without extraction during follow-up.
Up to 5 years
Root Development Stage of the Autotransplanted Tooth
Time Frame: Up to 5 years
Root development stage of the autotransplanted tooth assessed radiographically using the Moorrees classification.
Up to 5 years
Pulpal Healing Status of the Autotransplanted Tooth
Time Frame: Up to 5 years
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.
Up to 5 years
Periodontal Probing Depth of the Autotransplanted Tooth
Time Frame: Up to 5 years
Mean periodontal probing depth (in millimeters) measured at six sites around the autotransplanted tooth.
Up to 5 years
Gingival Recession of the Autotransplanted Tooth
Time Frame: Up to 5 years
Gingival recession measured in millimeters from the cemento-enamel junction to the gingival margin at the mid-buccal site of the autotransplanted tooth.
Up to 5 years
Incidence of Root Resorption
Time Frame: Up to 5 years
Number of autotransplanted teeth presenting inflammatory or replacement root resorption detected radiographically.
Up to 5 years
Incidence of Ankylosis
Time Frame: Up to 5 years
Number of autotransplanted teeth presenting clinical and/or radiographic signs of ankylosis.
Up to 5 years
Orthodontic Treatment After Autotransplantation
Time Frame: Up to 5 years
Time (in months) from autotransplantation to initiation of orthodontic tooth movement of the autotransplanted tooth.
Up to 5 years
Number of Restorative Procedures Performed on the Autotransplanted Tooth
Time Frame: Up to 5 years
Total number of restorative procedures performed on each autotransplanted tooth during follow-up.
Up to 5 years
Oral Health-Related Quality of Life (OHIP-14 Score)
Time Frame: Up to 5 years
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.
Up to 5 years
Patient Satisfaction with Esthetic Outcome
Time Frame: Up to 5 years
Patient-reported satisfaction with dental esthetics measured using a Visual Analog Scale (VAS) from 0 to 10, where higher scores indicate greater satisfaction.
Up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alveolar Bone Volume at the Autotransplantation Site
Time Frame: Up to 5 years
Change in alveolar bone volume (in cubic millimeters, mm³) at the autotransplantation site assessed by CBCT superimposition at baseline and follow-up visits, when imaging is clinically indicated.
Up to 5 years
Change in Gingival Tissue Volume at the Autotransplantation Site
Time Frame: Up to 5 years
Change in gingival tissue volume (in cubic millimeters, mm³) assessed by STL model superimposition at baseline and follow-up visits, when digital models are available.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Montserrat Mercadé, PhD, Dental Esthetic BCN / Universitat de Barcelona
  • Principal Investigator: Jordi Cadellans, DDS, Dental Esthetic BCN / Universitat de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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