An observational study in Tooth Loss and Tooth Injury, sponsored by University of Barcelona. Recruiting at 1 site in Spain. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by University of Barcelona · Observational
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.
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 40 observational studies indexed under Tooth Loss.
Browse Tooth Loss studies →University of Barcelona is the lead sponsor of 98 studies on the registry; 29 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Premolar 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.
Also known as: Tooth Autotransplantation, Dental Autotransplantation
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.
Time frame: Up to 5 years
Survival Rate of the Autotransplanted Tooth
Number of autotransplanted teeth remaining in situ without extraction during follow-up.
Time frame: Up to 5 years
Root Development Stage of the Autotransplanted Tooth
Root development stage of the autotransplanted tooth assessed radiographically using the Moorrees classification.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Incidence of Root Resorption
Number of autotransplanted teeth presenting inflammatory or replacement root resorption detected radiographically.
Time frame: Up to 5 years
Incidence of Ankylosis
Number of autotransplanted teeth presenting clinical and/or radiographic signs of ankylosis.
Time frame: Up to 5 years
Orthodontic Treatment After Autotransplantation
Time (in months) from autotransplantation to initiation of orthodontic tooth movement of the autotransplanted tooth.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Change in Alveolar Bone Volume at the Autotransplantation Site
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.
Time frame: Up to 5 years
Change in Gingival Tissue Volume at the Autotransplantation Site
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.
Time frame: Up to 5 years
Plan to share: 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.
Started Dec 2019 (actual). Primary completion is estimated for Dec 2029, 120 months after the start.
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University of Barcelona