Evaluation of Enamel Matrix Derivative in Management of Jumping Gaps Around Immediate Dental Implants in Mandibular Molar Region. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Implant Stability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Immediate Implant with Enamel Matrix Derivative
Participants will receive an immediate dental implant in the mandibular molar region with the application of enamel matrix derivative (EMD) to the extraction socket. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months.
干预措施: Enamel Matrix Derivative (Emdogain) (Biological)
Immediate Implant with Enamel Matrix Derivative
Participants will receive an immediate dental implant in the mandibular molar region with the application of enamel matrix derivative (EMD) to the extraction socket. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months.
干预措施: Immediate Dental Implant Placement (Procedure)
Immediate Implant without Enamel Matrix Derivative
Participants will receive an immediate dental implant in the mandibular molar region without enamel matrix derivative (EMD). Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months.
干预措施: Immediate Dental Implant Placement (Procedure)
结局指标
主要结局
Implant Stability
时间窗: Baseline (implant insertion), 3 months, and 6 months post-implantation
Implant stability will be assessed using Resonance Frequency Analysis (RFA) with the Osstell ISQ device. Implant stability will be expressed as the Implant Stability Quotient (ISQ), which ranges from 1 to 100. Higher ISQ values indicate greater implant stability.
次要结局
- Marginal Bone Loss (MBL)(Immediately postoperatively and 6 months post-implantation)
- Modified sulcus bleeding index (mBI)(3 and 6 months post-implantation)
- Bone Density(Baseline and 6 months post-implantation)
