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Набор скоро начнётся NCT07675772

Delayed Short Dental Implants With Immediate Loading

Без фазы С лечением DENT IMPLANTS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dental Implant Surgery.
Кому может быть актуально
Состояния в реестре: DENT IMPLANTS. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Clinical and Radiographic Evaluation of the Role of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) in Enhancing the Wound Healing and Stability of Delayed Short Dental Implants With Immediate Loading: Randomized Controlled Clinical Trial

Обзор

\> Evaluation of the wound healing in immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF. \> Detection of the primary and secondary implant stability of immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF. \> Evaluation of the hard and soft tissue thickness after immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF.

Подробное описание

The term 'short implant' is subjective. In most publications this is defined as an implant length between 5 mm and 10 mm. The first implants of this type and length of 7 mm were introduced in 1979 by the Bränemark system. Today, most implantology companies offer implants shorter than 8 mm, which has led to their common use in clinically substantiated cases. The use of shorter implants is indicated in the lateral parts of the maxilla and the mandible. These regions are the most predisposed to atrophy because first molars are the first teeth lost in most cases. After their extraction, the atrophy of bone surface develops in 30-90% of cases. The extraction of first molars can also be the cause of further negative processes such as the mesial inclination of second molars towards the hole, which generates improper occlusal loading, leading to local bone atrophy.

The placement of short implants in treating edentulous patients eliminates the need for complicated surgeries to place conventional implants. Patient satisfaction will be increased as it avoids augmentation procedures, which result in short, inexpensive treatment options. Applying short implants in extremely resorbed mandibles (less than 10 mm bone height) might reduce the risk of mandibular fracture during penetration in the symphysis region, preserving the integrity of the lower mandibular cortex. Several studies concluded that many factors directly influence the success rates of short implants: implant diameter, length, number, stress distribution around the implant, marginal bone loss, implant thread design, and loading strategy for the prosthesis.

It was suggested that a short implant provides low-cost, acceptable, time-saving treatment instead of a long implant placed in the augmented bone while rehabilitating a completely edentulous atrophic maxilla. Significant failures occur with long implants in different augmented sites. Also, conventional dental implants had a triple increase in the chance of complications during insertion compared to short implants. A 5mm × 5mm implant gives the same results as a standard long implant placed in augmented bone after three years of loading. The short implant may be the first choice compared to bone augmentation.

Immediate occlusal loading refers to full functional occlusal loading of an implant within 2 weeks of placement. The authors gave guidelines for successful immediate implant loading with implants have good primary stabilization (placement torque of more than 40 Ncm) can be immediately loaded.

Immediate loading protocols are best in situations where the patient cannot tolerate two-stage surgeries or multiple visits; also, improve esthetics, enhance function, and comfort are expected. Concerning marginal bone loss and implant survival rate, the loading protocol is thought to be not relevant in the clinical success. A review suggested no significant difference between conventional and immediate loading protocols for conventional (normal-sized) implants, and this study also confirmed it about short implants. However, another review suggested that clinicians should be cautious about using immediate loading protocols for dental implants in the single-tooth restorations in the anterior maxilla because of probable marginal bone remodeling and gingival changes.

The survival rate of the immediate-loaded short implants was not statistically different from the conventional. Overall, the survival rate of immediate-loaded short implants in the mandible is higher than the maxilla. Other study found, the mean peri-implant marginal bone loss around the immediately loaded short implants was less than 1 mm. Immediately-loaded short implants have lost 0.4/0.5 mm less marginal bone than the long implants (up to 1 year follow-up), In another study, the 3-years marginal bone remodeling for short implants was 1.25 ± 0.99 mm.

Concentrated Growth Factor (CGF) was developed by Sacco in the year 2006. It is produced by centrifuging venous blood, as a result of which the platelets are concentrated in a gel layer, comprising of a fibrin matrix rich in growth factors and leukocytes. CGF acts by degranulation of the alpha granules in platelets which play a vital role in early wound healing. It has been found that CGF contains more GFs than the other platelet-based preparations such as platelet rich fibrin (PRF) and platelet-rich plasma (PRP), and unlike PRP, CGF does not dissolve rapidly following application.

In vitro studies have established the beneficial effects of CGF in promoting bone regeneration around implants. Animal studies have also reported its potential merits. CGF is now emerging as a viable treatment option due to various reasons. First, it has the capability for extended release of GFs, presenting a stronger effect on enhancement of wound healing around implants. Second, it can be used alone or in combination with synthetic graft materials and facilitate osseointegration. Third, it is easy to prepare and manipulate, and it is inexpensive.

Advanced platelet rich fibrin (APRF) first described in 2014 as a new concept for cell-based tissue engineering with decreasing the rotations per minute (rpm) while increasing the time of standard platelet rich fibrin (PRF). More platelets were found in distal part of APRF compare to standard PRF. It is simple, safe and inexpensive process which required patient's own blood. It accelerates the wound healing and minimizes the discomfort. The autogenous nature of A-PRF makes it simple to use and manipulate. According to the studies in the literature stated above, A-PRF is utilized successfully and without any complications in the periodontal regeneration and healing process.

There is also no anticoagulant, which gives A-PRF better biological properties compared to classical PRF. The lower centrifugation parameters of A-PRF compared to PRF or Leukocyte-PRF (L-PRF) do not allow the platelets to be pushed down the tube. The advantage of lower centrifuge speed in A-PRF preparation is the improvement of properties. Neutrophils can migrate to the fibrin matrix. A-PRF is primarily used in surgical procedures. However, it can also be used in implantology (bone regeneration, socket preservation, alveolar ridge preservation, maxillary sinus augmentation), periodontics (in treatment recessions) and to enhance general wound healing (reduced pain, swelling or trismus).

Cone-beam computed tomography (CBCT) is the most widely recommended imaging modality for implant planning since it allows precise 3-dimensional measurements of the implant bone site and accurate identification of anatomical structures and their variations. In dentistry, CBCT has been positioned as the modality of choice for cross-sectional imaging as an application that certainly has tangible implications for implant therapy. Generally speaking, CBCT technology is perceived as a radiographic tool with increased accuracy, higher resolution, lower radiation dose, and reduced cost for patients compared with other volumetric imaging modalities for the assessment of mineralized tissues. This notion has driven a robust interest to adopt this technology for routine dental implantology.

Вмешательства

  • Процедура Dental Implant Surgery
    Delayed Short Dental Implants with Immediate loading with or without growth factors.

Первичные конечные точки

  • Bleeding On Probing Index (BOP): [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Peri- implant mucosal tissue index (MTI): [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Jemt papilla index: [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Probing Pocket Depth (PPD) [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Modified plaque index (mPI): [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Mucosal recession (MR) [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Keratinized mucosa (KM) [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Gingival thickness Measurement [Срок оценки: at baseline, after 6 months, and after 12 months.]
Вторичные конечные точки (3)
  • Implant stability [Срок оценки: at baseline, after 6 months, and after 12 months.]
  • Marginal bone loss [Срок оценки: at baseline, after 6 months, and after 12 months]
  • Bone density Recording [Срок оценки: at baseline, after 6 months, and after 12 months]

Критерии участия

Критерии включения

\-

  • Patient aged 18 - 45 years old.
  • Patients maintaining excellent oral hygiene standards.
  • Systemically healthy patient.
  • Single or multiple missing teeth in premolar and molar region.
  • Patients should have adequate bone width volume (>4 mm) and bone density with sufficient mesiodistal and interocclusal space. Bone height (≤10mm).
  • The patient should physically and psychologically be able to tolerate short implant surgical procedure.
  • Patient with a sufficient platelet count (>200,000/mm3) for CGF and A-PRF preparation.
  • Patients who provided informed consent.

Критерии исключения

  • > Presence of active periodontal disease.

Patients with a significant medical history which contradicts placement of dental implants such as:

  • Diabetes.
  • Diseases affecting bone metabolism.
  • Patients currently on antibiotics, steroids, hormonal therapy, or medications known to affect bone metabolism.
  • Patients with a history of radiotherapy or chemotherapy, coagulation defects, or currently on anticoagulant treatment.
  • Pregnant or lactating women.
  • Patients with poor oral hygiene.
  • Habits such as khat chewing, smoking and alcohol intake.
  • Insufficient vertical interarch space.
  • Temporomandibular joint disorder.
  • Parafunctional habits.

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07675772 · Short Dental Implant

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗