Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns

Официальное название

Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial

Обзор

This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants. The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes. Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.

Подробное описание

Study design:

This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.

The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.

Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.

Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.

Вмешательства

• Устройство Immediate loading of early placed implants
  Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.
• Устройство Conventional loading of early placed implants
  Definitive loading of early placed implants upon successful osteointegration (after 8 weks)

Первичные конечные точки

• Marginal bone level changes [Срок оценки: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), and at 1-year follow-up post-loading.]

Вторичные конечные точки (6)

• Implant failure rate [Срок оценки: 1 year]
• Implant stability [Срок оценки: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group)]
• Midfacial mucosal level [Срок оценки: at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up]
• Pink and white esthetic scores [Срок оценки: at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up]
• Patient Satisfaction [Срок оценки: after 6 months and 1 year of placements]
• Biological, estehtic and technical complications [Срок оценки: 1 year]

Критерии участия

Критерии включения

• aged 18 years or older
• requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)
• having adequate bone volume
• controlled oral hygiene
• having agreed to take part in the study and willing to comply with the study protocol and follow-up visits

Критерии исключения

• Any systemic condition that might jeopardize implant surgery
• history of radiation therapy to the head and neck region
• history of bisphosphonate therapy or other medications that may affect bone metabolism
• smoking more than 10 cigarettes/day
• history of bruxism or parafunctional habits
• localized/generalized periodontitis
• patients in need of bone grafting
• any known allergy or hypersensitivity to implant materials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Иордания · 1 центр

• Jordan University Hospital — Amman

Идентификаторы

NCT: NCT06693297 · 10/2024/22294

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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