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

NCT ID: NCT07314580

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Tooth Loss Tooth Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Tooth Autotransplantation Dental Autotransplantation

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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MONTSERRAT MERCADE BELLIDO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Montserrat Mercadé, PhD

Role: PRINCIPAL_INVESTIGATOR

Dental Esthetic BCN / Universitat de Barcelona

Jordi Cadellans, DDS

Role: PRINCIPAL_INVESTIGATOR

Dental Esthetic BCN / Universitat de Barcelona

Locations

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Dental Esthetic BCN

Barcelona, Barcelons, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Montserrat Mercadé, PhD

Role: CONTACT

+34 934011235

Jordi Cadellans, DDS

Role: CONTACT

+34 934011235

Facility Contacts

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Xavier Rodriguez Ciurana, PhD

Role: primary

+34 936404390

Related Links

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http://dentalestheticbcn.com

Dental Esthetic BCN

Other Identifiers

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63/2025

Identifier Type: OTHER

Identifier Source: secondary_id

63/2025-V3

Identifier Type: -

Identifier Source: org_study_id

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