Evaluation of Enamel Matrix Derivative in Immediate Dental Implants in the Mandibular Molar Region

Официальное название

Evaluation of Enamel Matrix Derivative in Management of Jumping Gaps Around Immediate Dental Implants in Mandibular Molar Region. A Randomized Clinical Trial

Обзор

This randomized clinical trial will evaluate the effect of using an enamel matrix derivative during immediate dental implant placement in the mandibular molar region. Patients who require extraction of a non-restorable mandibular molar and immediate implant placement will be randomly assigned to receive an implant placed with enamel matrix derivative or without enamel matrix derivative. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be assessed over a follow-up period of six months. The results of this study aim to determine whether the use of enamel matrix derivative improves osseointegration and healing around immediate dental implants.

Подробное описание

Immediate dental implant placement following tooth extraction is a commonly used treatment approach, but achieving predictable osseointegration and preservation of peri-implant bone remains challenging, particularly in the presence of jumping gaps. Enamel matrix derivative is a biologically active material that has been shown to enhance periodontal and bone healing, but its effects around immediate dental implants are not fully established.

This randomized clinical trial will be conducted at the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Twenty-four patients requiring extraction of a single non-restorable mandibular molar will be enrolled and randomly allocated into two equal groups. In the test group, immediate dental implants will be placed with the application of enamel matrix derivative, while in the control group implants will be placed without enamel matrix derivative.

Clinical outcomes will include implant stability measured using resonance frequency analysis and peri-implant soft tissue health assessed by modified sulcus bleeding index. Radiographic outcomes will be evaluated using cone beam computed tomography to assess peri-implant bone dimensional changes, marginal bone loss, and bone density. Assessments will be performed at baseline and during follow-up visits up to six months after implant placement.

Вмешательства

• Биопрепарат Enamel Matrix Derivative (Emdogain)
  A single application of enamel matrix derivative (EMD, commercially known as Emdogain) will be applied to the extraction socket during immediate dental implant placement in the mandibular molar region. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months. The dental implant used is a conventional screw-type titanium implant.
• Процедура Immediate Dental Implant Placement
  Participants will receive immediate dental implant placement in the mandibular molar region without enamel matrix derivative. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months. The dental implant used is a conventional screw-type titanium implant.

Первичные конечные точки

• Implant Stability [Срок оценки: Baseline (implant insertion), 3 months, and 6 months post-implantation]

Вторичные конечные точки (3)

• Marginal Bone Loss (MBL) [Срок оценки: Immediately postoperatively and 6 months post-implantation]
• Modified sulcus bleeding index (mBI) [Срок оценки: 3 and 6 months post-implantation]
• Bone Density [Срок оценки: Baseline and 6 months post-implantation]

Критерии участия

Критерии включения

• Patients with non-restorable mandibular molar requiring dental extraction.
• Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
• Age range: from (18 to 45) years.
• Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration (8-12mm).
• Extraction sockets with intact bony walls and interradicular bone.
• Jumping gap more than 2mm.
• Patients with good oral hygiene.
• Patients willing to participate in the study's follow-up intervals.

Критерии исключения

• Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
• smoker patients.
• Pregnant patients.
• Patients with para-functional habits (bruxism and clenching)

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07727655 · MS.26.01.105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗