Peri-Implant Hard and Soft Tissue Changes After Immediate Implant Placement With Socket Shield and Immediate Restoration Versus Early Implant Placement in the Esthetic Zone

Официальное название

Evaluation of Peri-implant Hard And Soft Tissues Changes Between Immediate Implant Placement With Socket Shield Technique and Immediate Restoration Versus Early Type II Implant Placement in The Esthetic Zone - A Randomized Controlled Clinical Trial

Обзор

This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.

Подробное описание

Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.

This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.

Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:

Test group: Immediate implant placement with socket shield technique and immediate restoration.

Control group: Early implant placement following soft tissue healing with contour augmentation.

Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.

Вмешательства

• Процедура Socket Shield
  mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported res
• Процедура Early Implant Placement
  atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be re

Первичные конечные точки

• Pink Esthetic Score (PES) [Срок оценки: 12 months after implant restoration]

Вторичные конечные точки (4)

• Peri-implant Mid-facial Mucosal Recession [Срок оценки: 12 months after implant placement]
• Horizontal Radiographic Peri-implant Bone Changes [Срок оценки: 12 months after implant Restoration]
• Vertical Radiographic Peri-implant Bone Changes [Срок оценки: 12 months after implant Restoration]
• Patient Satisfaction [Срок оценки: 12 months after implant restoration]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
• Presence of a thin buccal bone plate (<1 mm)
• Adequate bone volume to allow implant placement in a prosthetically ideal position
• Intact socket walls following tooth extraction
• Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
• Patients willing to participate in the study and able to provide written informed consent

Критерии исключения

• History of systemic diseases that may affect bone healing
• Use of medications that may influence bone metabolism (e.g., bisphosphonates)
• Smoking within the past 5 years
• Presence of acute infection at the surgical site or adjacent teeth
• Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
• Presence of internal or external root resorption
• Severe periodontal destruction at the implant site

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

Простое слепое

Основная цель

Лечение

Центры проведения

ОАЭ · 1 центр

• Gulf Medical University — Ajman

Идентификаторы

NCT: NCT07468760 · IRB-COD-STD-87-Feb-2025 · IRB-COD-STD-87-Feb-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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