Идёт набор NCT07314580

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

— Наблюдательное Tooth Loss Tooth Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Premolar Autotransplantation.
Кому может быть актуально: Состояния в реестре: Tooth Loss, Tooth Injury. Базовые параметры: 7 лет — 15 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Clinical, Radiographic, Functional and Psychosocial Evaluation of Premolar Autotransplantation to the Anterior Maxillary Region in Young Patients: An Ambispective Observational Study

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура 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.

Первичные конечные точки

Number of Autotransplanted Teeth with Clinical and Radiographic Success [Срок оценки: Up to 5 years]

Вторичные конечные точки (11)

Survival Rate of the Autotransplanted Tooth [Срок оценки: Up to 5 years]
Root Development Stage of the Autotransplanted Tooth [Срок оценки: Up to 5 years]
Pulpal Healing Status of the Autotransplanted Tooth [Срок оценки: Up to 5 years]
Periodontal Probing Depth of the Autotransplanted Tooth [Срок оценки: Up to 5 years]
Gingival Recession of the Autotransplanted Tooth [Срок оценки: Up to 5 years]
Incidence of Root Resorption [Срок оценки: Up to 5 years]
Incidence of Ankylosis [Срок оценки: Up to 5 years]
Orthodontic Treatment After Autotransplantation [Срок оценки: Up to 5 years]
Number of Restorative Procedures Performed on the Autotransplanted Tooth [Срок оценки: Up to 5 years]
Oral Health-Related Quality of Life (OHIP-14 Score) [Срок оценки: Up to 5 years]
Patient Satisfaction with Esthetic Outcome [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

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.