Evaluating the Effectiveness of Guided Endodontic Microsurgery in Critical Anatomical Structures (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Radiographic Success at 12 months
研究概览
简要总结
In recent years, there was a great interest in employing the surgical guide in dentistry due to the development occurred in the 3D printing which became available widely.
Cone beam computed tomography (CBCT) is necessary and crucial in planning for endodontic surgery, but the procedure still depends on how the surgeon reflect the 3D images on the anatomical structures accurately, which may leave room for error.
This study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
详细描述
Endodontic microsurgery in critical anatomical structures is considered as a serious challenge for the endodontist.
Major advances have been made to the techniques used in endodontic surgery to make the procedure easier to perform, safer and more predictable.
Several case reports that used surgical guide in endodontic microsurgery found that the procedure was more accurate in control of depth, diameter and angle of osteotomy.
The aim of this study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
Patients will be selected that they are indicated for endodontic surgery. Upper and lower teeth will be selected close to critical anatomy such as; maxillary sinus, nasal fossa, mental foramen and mandibular canal. medical and dental history will be obtained from all selected patients. Patients will be randomly distributed to either guided micro-surgery group or conventional micro-surgery group. All steps of the surgical procedure will be performed under microscopic magnification. Bioceramic putty will be used as a root-end filling material. Post-surgical instructions will be given to patients. The time of the surgery will be recorded from the first incision to the last suturing. Success and failure will be assessed using radiographic and clinical evaluation at 6 and 12 months.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in good general health.
- •Patients with age ranging between 18-50 years.
- •Posterior/anterior teeth close to critical anatomical structures that indicated for endodontic surgery.
- •Patients' acceptance to participate in the trail.
排除标准
- •Patients with allergy to materials or medications used in the trial.
- •Patients with Serious systemic disease incompatible with surgery.
- •Pregnant female patients.
- •Teeth with periapical pathosis associated with vertical root fracture.
- •Non-restorable teeth.
- •Teeth with periodontal probe more than 5 mm.
研究组 & 干预措施
Guided Endodontic Micro-Surgery
Use of the 3-D printed guide in endodontic micro-surgery
干预措施: 3-D printed Guide (Device)
Conventional Endodontic Micro-Surgery
Free-hand endodontic micro-surgery
干预措施: Conventional Endodontic Micro-Surgery (Other)
结局指标
主要结局
Radiographic Success at 12 months
时间窗: Periapical tissues healing will be evaluated radiographically at 12 months after surgery
Radiographic Success will be defined as either complete or incomplete healing (formation of scar tissue). Radiographic Failure will involve either uncertain healing (small or constant lesion size) or unsatisfactory healing (increased lesion size). The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images
Clinical Success at two weeks
时间窗: Periodontal tissue healing will be evaluated clinically "2 weeks"
The position of the oral mucosa at the flap site will be assessed after surgery to evaluate wound healing using the wound healing index (WHI) by Huang et al 2005 as the following criteria: Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Clinical Success at one year
时间窗: Clinical signs or symptoms will be evaluated "1 year"
The patient's symptoms will be evaluated and the examination will be done on percussion, palpation and probing. Clinical Success will be defined as absence of pain, swelling or sensitivity on percussion. Clinical failure is the persistence of any of the above-mentioned symptoms.
Radiographic Success at 6 months
时间窗: Periapical tissues healing will be evaluated radiographically at 6 months after surgery
Early follow-up will be done and the initial radiographic Success or failure will be assessed. The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images
次要结局
- Time of surgery(During surgery)
- Change in Pain Perception(Pain will be evaluated at 24, 48, and 72 hours after surgery)