Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.

Официальное название

Evaluation of Peri-implant Bone Changes Around One-piece Implant and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full Arch Prosthesis: a Randomized Controlled Clinical Trial

Обзор

Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.

Подробное описание

Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.

Вмешательства

• Устройство One-piece dental implants with MUA
  one-piece dental implants with multi-units abutment mounted on the implants as a single piece provided with different abutment angulation utilizing these implants for All-On-Four prothesis
• Устройство Two-piece dental implants
  Surgical and immediate loading procedures: On the day of implant placement, patients will receive two-piece implant. After crestal incision and full-thickness flap elevation, the implant sites will be prepared aided by a surgical template. 4 implants will be placed, two aligned in an axial orientation and two will be distally aligned (17 degrees). The standard placement procedure as recommended by the manufacturer will be used. The surgical drills with increasing diameters will be used to prepa

Первичные конечные точки

• Peri-implant marginal bone loss [Срок оценки: From implant placement (baseline) and After 3 months (after the osseointegration phase)]

Критерии участия

Критерии включения

• Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.
• Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.
• Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.

Критерии исключения

• \- Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).
• Inadequate mouth opening
• Heavy smokers, more than 10 cigarettes/day
• Patients with poor oral hygiene and motivation.
• Pregnancy or nursing.
• Drug abusers.
• Psychiatric problems or unrealistic expectations.
• Patients with infection and or inflammation in the area intended for implant placement.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of dentistry, Cairo University — Cairo

Идентификаторы

NCT: NCT06790524 · one-piece implants

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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