Evaluation of Doxycycline Nanoparticle With Gelatin Sponge on Immediate Implant in Esthetic Region

Официальное название

Clinical and Radiographic Evaluation of Doxycycline and Doxycycline Loaded Nanoparticles With Gelatin Sponge on Immediate Implant Placement in Esthetic Zone: A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to Evaluate the effect of Doxycycline nanoparticles along with gelatin sponge in immediate implant cases in esthetic zone. The main question it aims to answer is: Does the application of doxycycline nanoparticles with gelatin sponge improve the clinical and radiographic outcomes of immediate implant cases in esthetic zone? Researchers will compare eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) with eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B). to see if the doxycycline loaded nanoparticles will improve the clinical and radiographic outcomes of the immediate implant . Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Вмешательства

• Процедура Immediate Implant Placement
  Eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) Eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B)

Первичные конечные точки

• Marginal (crestal) bone loss (MBL). [Срок оценки: after surgery and 6 months after surgery]

Вторичные конечные точки (4)

• Pink Esthetic Score [Срок оценки: before the surgery, 3 months and 6 months after the surgery]
• Peri-Implant Periodontal Probing depth (PPD): [Срок оценки: 3 months and 6 months after the surgery]
• Peri-implant vertical bone level. [Срок оценки: after surgery and 6 months after surgery]
• Implant stability [Срок оценки: at the time of surgery, 3 months and 6 months post surgery]

Критерии участия

Критерии включения

• The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
• Sufficient bone volume.
• Good oral hygiene.
• The remaining space between the socket and the fixture equals or more than 2mm at the coronal third of the socket.
• Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).

Критерии исключения

• Insufficient bone volume.
• Active infection.
• Patients on chemotherapy or radiotherapy.
• Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, …etc},
• Pregnant patients,
• Patients with bone diseases
• Presence of periapical pathology affecting the neighbouring teeth.
• Smokers.

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 kafrelsheikh university — Kafrelsheikh

Идентификаторы

NCT: NCT06809829 · KFSIRB200-482

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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