Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach

Официальное название

Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach: A 1-year Randomized Clinical Trial

Обзор

Rehabilitation of the maxillary posterior region is a challenge in every-day clinical practice. Following extraction of maxillary molars, alveolar ridge atrophy along with maxillary sinus pneumatization decrease the bone volume and increase implant placement complexity (Lyu et al., 2023). Several surgical procedures have been proposed to overcome these complications, including; short implants (Bechara et al., 2017), tilted implants (Meng and Zhang, 2022) as well as different sinus floor elevation techniques (Irinakis, 2011, Bishbish et al., 2023, Dragonas et al., 2023). Crestal maxillary sinus floor elevation has been considered a predictable and less invasive approach, providing sufficient vertical ridge height with high rates of implant survival (Guruprasad et al., 2024). However, there's limited body of evidence comparing the efficacy of different trans-crestal approaches as PISE and crestal implant approach with no bone graft. Thus, further clinical trials are recommended to determine whether the adjunctive use of piezoelectric instrumentation in internal sinus elevation offers significant clinical advantages over the crestal implant approach.

Подробное описание

Aim of the study: The aim of this study is to evaluate clinical long term implant stability and radiographic vertical bone height gain after implant placement in posterior maxilla using crestal implant approach in comparison to PISE.

Hypothesis:

Research Null hypothesis: There will be no difference between implants placed with crestal implant approach and PISE, regarding long term implant stability and radiographic bone height gain.

The primary objective:

• To compare the implant stability quotient (ISQ) between the two treatment modalities, will be assessed by resonance frequency analysis using "Osstell" (Integration Diagnostics, Save Dalen, Sweden)

The secondary objectives:

* To assess intra-sinus vertical bone gain around dental implants, in mm, will be assessed by CBCT. * To assess marginal bone level, in mm * To assess peri-implant soft tissue parameters by modified plaque and bleeding indices. * To evaluate post-operative pain. * To assess any surgical or post-surgical complications.

Вмешательства

• Процедура PISE
  Osteotomy site preparation will be initiated using a piezoelectric ultrasonic osteotome under sterile irrigation. Sequential osteotomy preparation will be carried out while maintaining the planned implant angulation 1 mm short of the sinus floor based on preoperative radiographic measurements done using the CBCT. Thinning the sinus floor will be achieved after using subsequent widening drills and the integrity of the Schneiderian membrane and the residual bone thickness will be verified using pe
• Процедура Crestal implant approach
  Osteotomy site preparation and implant drilling sequence were performed according to the manufacturer's instructions. Drilling will be done gently till reaching 0.5-1mm from the sinus floor, checked by periapical radiographs with the drills placed in the osteotomy. During implant placement, the sinus membrane will be gently elevated with the blunt rounded circular apex of the implant

Первичные конечные точки

• Intra Sinus bone formation [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patients who have at least one missing posterior maxillary tooth with sound adjacent and opposing dentition.
• Adults above the age of 21.
• Bone height from 4mm to 6mm under the maxillary sinus assessed in CBCT.
• Good oral hygiene.
• Patient accepts to provide an informed consent.

Критерии исключения

• Smokers.
• Pregnant and lactating females.
• Medically compromised patients.
• Patients with untreated active periodontal diseases.
• Patients with active infection related to the implant site.
• Patients with parafunctional habits.
• Patients with Acute or chronic sinusitis.
• Presence of sinus septa
• History of radiotherapy or chemotherapy within the past 2 years

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• ALBREKTSSON, T. 1993. On long-term maintenance of the osseointegrated response. Aust Prosthodont J, 7 Suppl, 15-24. ALBREKTSSON, T., ZARB, G., WORTHINGTON, P. & ERIKSSON, A. R. 1986. The long-term efficacy of currently used dental implants: A review and proposed criteria of success. The International journal of oral & maxillofacial implants, 1, 11-25. BALDI, D., MENINI, M., PERA, F., RAVERA, G. &

Идентификаторы

NCT: NCT07433868 · IDCE-41722026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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