Набор скоро начнётся NCT07629752

Immediate Loading of Implants in the Aesthetic Zone Using Three-dimensionally Printed Provisional Crowns: a 1-year Prospective Case Series Study

— Наблюдательное Dental Implants, Single-tooth Crown

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Dental Implants, Single-tooth, Crown. Базовые параметры: от 18 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: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

• Background There is a growing tendency to place a provisional crown immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better aesthetic outcomes. It was shown that good esthetic results can be achieved on the long term with immediate provisionalization of single-tooth implants placed in either fresh extraction sockets or after alveolar ridge preservation/reconstruction in the maxillary esthetic zone. One recent development in three-dimensional printing is digital press stereolithography (DPS), which overcomes the challenges of printing highly-filled viscous materials. This enables the use of more durable materials than traditional three-dimensionally printed provisional crowns and allows for rapid additive production of prosthetic restorations. Until date, no studies have been described investigating immediate loading of implants in the aesthetic zone using three-dimensional DPS-printers and their impact on patient-satisfaction. * Main research question The purpose of this one-year prospective case series study is to perform an assessment of patient-reported outcomes of single-tooth implants with immediate provisionalization using three-dimensionally printed provisional crowns. * Design (including population, confounders/outcomes) The study design is a prospective, single-arm observational study for evaluation of 30 patients with a failing tooth in the maxillary aesthetic region to be treated with an implant-supported provisional and definitive restoration by means of a provisional and definitive crown. Outcomes: registration of time/complications during the diagnostic/planning/manufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome. * Expected results Satisfying results for patients and professionals (VAS-scores and PES/WES-scores)

Подробное описание

• Introduction and rationale There is a growing tendency to place a provisional crown immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better aesthetic outcomes (El Ghoul \& Chidiac, 2012). It was shown that good esthetic results can be achieved on the long term with immediate provisionalization of single-tooth implants placed in either fresh extraction sockets or after alveolar ridge preservation/reconstruction in the maxillary esthetic zone (Donker et al., 2024; Meijer et al., 2025).

The popularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba et al., 2018). Developments in the digital workflow in implant dentistry made treatment planning with the use of intra-oral scans and cone-beam computed tomography (CBCT) and fabrication of a provisional restoration using three-dimensional printers for additive manufacturing possible, further shortening the treatment duration. It was shown that patients prefer intra-oral scanning over analog impression taking (Schepke et al., 2015). Thus, it can be assumed that a digital workflow has advantages over an analog workflow for both the clinician and patients. One recent development in three-dimensional printing is digital press stereolithography (DPS), which overcomes the challenges of printing highly-filled viscous materials. This enables the use of more durable materials than traditional provisional crowns and allows for rapid additive production of prosthetic restorations.

Until date, no studies have been described investigating immediate loading of implants in the aesthetic zone using three-dimensional DPS-printers and their impact on patient-satisfaction.

The purpose of this one-year prospective case series study is to perform an assessment of patient-reported outcomes of single-tooth implants with immediate provisionalization using three-dimensionally printed provisional crowns, with respect to registration of time/complications during the diagnostic/planning/manufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome.

Первичные конечные точки

Change in peri-implant marginal bone level Description: Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs Time Frame: Through study completion, an average of 1 year [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (6)

Implant and restoration survival [Срок оценки: Through study completion, an average of 1 year]
Patient satisfaction [Срок оценки: 1 year]
Plaque score [Срок оценки: 1 year]
Gingival score [Срок оценки: 1 year]
Pocket depth [Срок оценки: 1 year]
Bleeding score [Срок оценки: 1 year]

Критерии участия

Критерии включения

The patient is 18 years or older;
The implant region is an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
Sufficient healthy and vital bone after alveolar ridge preservation to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability > 45 Ncm;
The implant site must be free from infection;
Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic crown;
The provisional crown can be designed free from occlusal contact;
The patient is capable of understanding and giving informed consent.