Comparison Between Modified Periosteal Inhibition (MPI) and Flapless Immediate Implant Placement

Официальное название

Impact of Modified Periosteal Inhibition Technique on Alveolar Bone Stability in Immediate Implant Placement Procedures (Randomized Controlled Clinical Trial)

Обзор

To clinically and radiographically assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement, on alveolar bone dimensional changes, in comparison to the conventional flapless immediate implant approach.

Подробное описание

To assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement in comparison to the conventional flapless immediate implant approach on radiographically by assessing marginal bone level measurements and bucco-lingual alveolar width. Clinically, pain levels, wound healing index, primary, secondary implant stability measured by resonance frequency analysis (RFA), peri-implant probing depth, and pink esthetic score (PES) will be assessed.

Вмешательства

• Процедура Immediate implant placement via flapless approach
  Implant site preparation will be performed flapless using 3D computer assisted planned surgical stent. Implant site preparation will be performed using commercially available standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. Cortico-cancellous bone allograft will be inserted inside the extraction socket in the gap distance between the implant and surrounding alveolar bone of the fresh extraction socket.
• Процедура Immediate implant placement in conjunction with modified periosteal inhibition technique using collagen sponge in the gap distance
  After papillae incisions, an intra-sulcular incision will be made on the vestibular side of the extraction socket, extending to the mesial and distal mid-tooth with a #15c surgical scalpel. Implant site preparation will be performed using 3D computer assisted planned surgical stent. Implant site preparation will be performed using a standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. A full-thickness flap will be elevated creating a room that wo
• Процедура Immediate implant placement in conjunction with modified periosteal inhibition technique using cortico-cancellous bone allograft in the gap distance
  After papillae incisions, an intra-sulcular incision will be made on the vestibular side of the extraction socket, extending to the mesial and distal mid-tooth with a #15c surgical scalpel. Implant site preparation will be performed using 3D computer assisted planned surgical stent. Implant site preparation will be performed using a standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. A full-thickness flap will be elevated creating a room that wo

Первичные конечные точки

• Radiographic evaluation of horizontal and vertical dimensional changes of the alveolar bone placement by using cone beam computed tomography (CBCT). [Срок оценки: Baseline, 6 months, 12 months after the implant placement]

Вторичные конечные точки (5)

• Pain Index [Срок оценки: first post-operative day, third day and after one week.]
• Wound Healing Index (WHI) [Срок оценки: 1 and 2 weeks after surgery]
• Implant Stability Measurements [Срок оценки: The RFA measurements will be made immediately after implant installation, and 3 months after implant placement before the prosthetic phase.]
• Peri-implant Probing Depth (PPD) [Срок оценки: Baseline, 6 months and 12 months post-operatively.]
• Esthetic Evaluation [Срок оценки: At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively]

Критерии участия

Критерии включения

• Patient's age ranges between 20 and 50 years including both genders.
• General good health (American Society of Anesthesiologists I-II).
• Presence of one hopeless non-restorable tooth requiring extraction at the posterior region.
• Adequate amount of palatal bone and basal bone (≥ 3 mm) to engage the immediately placed implants.
• Adequate keratinized soft tissue.
• Thick gingival phenotype (˃ 1.5 mm).
• Thin buccal bone plate or presence of fenestration.
• Favorable pattern of occlusion.
• Patient who is able to understand and sign a written consent.

Критерии исключения

• Pregnancy or lactating females.
• Untreated periodontitis.
• Acute dentoalveolar infection.
• Complete absence of buccal bone plate.
• Osteometabolic disease.
• Chemotherapy or radiation therapy history of the neck-head area within the past 12 months.
• Heavy smokers (>20 cigarettes/per day) according to WHO.

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

Египет · 1 центр

• Faculty of Dentistry, Mansoura university — Al Mansurah

Идентификаторы

NCT: NCT07238738 · MPI with immediate implant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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