Immediate Implant Placement Using Socket Shield With CGF

Официальное название

Clinical and Radiographic Evaluation of Concentrated Growth Factors With Simultaneous Immediate Implant Placement in Socket Shield Technique

Обзор

This prospective case series study aims to clinically and radiographically evaluate the effectiveness of the socket shield technique combined with concentrated growth factors (CGF) in immediate implant placement in the esthetic zone. Outcomes will include crestal bone level changes assessed by CBCT and implant stability measured using Osstell.

Подробное описание

This prospective case series study will be conducted to evaluate clinically and radiographically the effectiveness of the socket shield technique combined with concentrated growth factors (CGF) during immediate implant placement in the esthetic zone.

Eligible patients requiring extraction and immediate implant placement in the maxillary anterior or premolar region will be included. Following atraumatic extraction, partial extraction therapy using the socket shield technique will be performed, leaving the buccal root fragment in place. Implant osteotomy and placement will then be carried out according to manufacturer instructions.

Autologous concentrated growth factors will be prepared from the patient's blood using a CGF centrifugation protocol. The CGF gel will be packed into the jumping gap between the implant and socket wall to promote bone regeneration and healing.

Clinical and radiographic evaluation will be performed using CBCT at baseline, 2 weeks, and 6 months postoperatively. The primary outcome will be crestal bone level changes measured radiographically, while the secondary outcome will include implant stability assessed using Osstell measurements (ISQ values).

Seven participants will be recruited in this case series. Follow-up will be conducted to evaluate healing, bone remodeling, and implant stability.

Вмешательства

• Процедура Immediate implant placement with Socket Shield Technique and CGF
  Partial extraction therapy using the socket shield technique followed by immediate implant placement. Concentrated growth factors prepared from autologous blood will be packed in the jumping gap to enhance bone regeneration and healing.

Первичные конечные точки

• Crestal bone level [Срок оценки: 2 weeks and 6 months post-operatively]

Вторичные конечные точки (1)

• Implant stability [Срок оценки: Immediately after implant placement and at 6 months]

Критерии участия

Критерии включения

• Age ≥18 years old. (Younis, W., \& El-Rashidy, A. 2020).
• Both male and female patients.
• Maxillary, anterior and premolar segment.

Критерии исключения

• A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
• Presence of active or untreated periodontal disease.
• Vertical root fractures involving the buccal aspect.
• Tooth /teeth with horizontal fractures below bone level.
• Tooth /teeth with external or internal resorption.
• Patients with destructive oral habits such as smoking, chewing tobacco, bruxism, etcetera.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT07520526 · omfs_ 3-3-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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