Clinical, Radiographic, Functional and Psychosocial Evaluation of Premolar Autotransplantation to the Anterior Maxillary Region in Young Patients: An Ambispective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Autotransplanted Teeth with Clinical and Radiographic Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients older than 15 years.
- •Severe systemic disease.
- •Inability or unwillingness to attend scheduled follow-up visits.
- •Lack of a suitable donor premolar.
结局指标
主要结局
Number of Autotransplanted Teeth with Clinical and Radiographic Success
时间窗: 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.
次要结局
- Survival Rate of the Autotransplanted Tooth(Up to 5 years)
- Root Development Stage of the Autotransplanted Tooth(Up to 5 years)
- Pulpal Healing Status of the Autotransplanted Tooth(Up to 5 years)
- Periodontal Probing Depth of the Autotransplanted Tooth(Up to 5 years)
- Gingival Recession of the Autotransplanted Tooth(Up to 5 years)
- Incidence of Root Resorption(Up to 5 years)
- Orthodontic Treatment After Autotransplantation(Up to 5 years)
- Incidence of Ankylosis(Up to 5 years)
- Number of Restorative Procedures Performed on the Autotransplanted Tooth(Up to 5 years)
- Oral Health-Related Quality of Life (OHIP-14 Score)(Up to 5 years)
- Patient Satisfaction with Esthetic Outcome(Up to 5 years)
研究者
MONTSERRAT MERCADE BELLIDO
Principal Investigator
University of Barcelona