Predictors For Transosseous Maxillary Sinus Lift Complications

Официальное название

Predictors For Transosseous Maxillary Sinus Lift Complications: A Prospective Cohort Study

Обзор

This prospective cohort study aims to identify clinical and anatomical predictors for complications following transosseous maxillary sinus lift procedures using the Versah (Densah burs) technique. The study focuses on patients undergoing transcrestal sinus floor elevation without a lateral window, with or without simultaneous dental implant placement. Variables such as residual bone height, sinus membrane thickness, bone density, and patient-related factors are being evaluated. The objective is to enhance risk stratification and optimize treatment planning for transosseous sinus augmentation.

Подробное описание

This prospective cohort study investigates potential predictors of complications associated with transosseous sinus lift procedures utilizing the Versah Densah burs technique. Unlike the traditional lateral approach, this method enables internal sinus floor elevation through a crestal access, minimizing invasiveness while allowing for controlled vertical augmentation.

The study population includes partially edentulous patients in need of vertical ridge augmentation in the posterior maxilla. The following parameters are evaluated as possible predictors of intraoperative and postoperative complications:

1. Residual Bone Height (RBH): Measured from the alveolar crest to the sinus floor. 2. Maxillary Sinus Ostium (MSO) Patency: Assessed radiographically to determine if ostial obstruction contributes to sinus-related events. 3. Schneiderian Membrane Thickness: Measured preoperatively via CBCT, as thicker or thinner membranes may influence perforation risk. 4. Surgical Site Location: Categorized based on the involved maxillary posterior region (e.g., premolar vs. molar). 5. Amount of Vertical Lifting: The total height gained through osteotome-mediated or Densah bur-mediated elevation is recorded.

Primary outcome measures include intraoperative membrane perforation, postoperative sinusitis, implant failure, and the need for revision surgery. The study aims to establish reliable preoperative indicators to stratify complication risk, facilitate clinical decision-making, and improve patient outcomes in transosseous sinus elevation procedures.

Вмешательства

• Процедура Transosseous Maxillary Sinus Lift using Osseodensification
  A surgical procedure utilizing the Versah® osseodensification technique for transcrestal sinus floor elevation. The approach involves the use of specialized Densah® burs to prepare the osteotomy and elevate the sinus membrane through a transosseous (crestal) access, avoiding the lateral window technique. No grafting materials will be used in this procedure.

Первичные конечные точки

• Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors [Срок оценки: Intraoperative phase to 1 month post-surgery]

Вторичные конечные точки (1)

• Postoperative Infection Rate [Срок оценки: Within 3 months postoperatively]

Критерии участия

Критерии включения

• 1- Patients requiring dental implants in the posterior maxilla with a residual bone height of < 6 mm.

2- Good general health and absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).

3- No history of chronic sinusitis or other significant sinus pathologies

Критерии исключения

• 1- Severe periodontal disease. 2- Residual bone height > 6 mm. 3- History of previous sinus lift procedures or other maxillofacial surgeries. 4- Smokers.

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

Организация здравоохранения

Центры проведения

Ирак · 2 центра

• College of Dentistry , University of Baghdad — Baghdad
• Planto clinic — Baghdad

Публикации

• Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14. PMID 27741329

Идентификаторы

NCT: NCT07017413 · 1045125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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