- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314580
Clinical and Radiological Evaluation of Dental Autotransplantation in the Anterior Region in Young Patients (YATA)
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Montserrat Mercadé, PhD
- Phone Number: +34 934011235
- Email: montsemercade@ub.edu
Study Contact Backup
- Name: Jordi Cadellans, DDS
- Phone Number: +34 934011235
- Email: jordicadellans@ub.edu
Study Locations
-
-
Barcelons
-
Barcelona, Barcelons, Spain, 08034
- Recruiting
- Dental Esthetic BCN
-
Contact:
- Xavier Rodriguez Ciurana, PhD
- Phone Number: +34 936404390
- Email: info@dentalestheticbcn.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
|
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
Sponsor
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
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- CBCT
- guided surgery
- orthodontics
- autotransplantation
- anterior maxilla
- young patients
- digital planning
- tooth autotransplant
- premolar donor tooth
- root development
- periodontal healing
- pulpal healing
- traumatic tooth loss
- avulsion injuries
- trauma-related anterior tooth loss
- Dental autotransplantation
- Anterior maxillary tooth loss
- tooth root development
Additional Relevant MeSH Terms
Other Study ID Numbers
- 63/2025-V3
- 63/2025 (Other Identifier: CEIm Universitat de Barcelona)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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