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临床试验/NCT07724964
NCT07724964已完成不适用

Clinical and Radiographic Characteristics and Treatment Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts in Premolar Teeth at Ho Chi Minh City Odonto-Stomatology Hospital

Can Tho University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Treatment Success Rate

研究概览

简要总结

Patients with periapical cysts associated with premolar teeth often require apical surgery when conventional endodontic treatment cannot resolve the lesion. Guided apicoectomy using a three-dimensional surgical guide may improve surgical accuracy while minimizing bone removal and reducing the risk of damage to adjacent anatomical structures.

This prospective single-arm interventional study aims to evaluate the clinical and radiographic characteristics of premolar teeth with periapical cysts and assess the treatment outcomes of guided apicoectomy with retrograde Mineral Trioxide Aggregate (MTA) filling. Forty-two participants will be treated and followed for six months. Clinical healing and radiographic bone healing will be evaluated one week, three months, and six months after surgery.

详细描述

Periapical cysts are common inflammatory lesions caused by pulpal infection and necrosis. Although conventional root canal treatment is effective in most cases, surgical intervention becomes necessary when persistent periapical lesions remain or true cysts develop.

Apicoectomy combined with retrograde filling using Mineral Trioxide Aggregate (MTA) has demonstrated high clinical success because of excellent sealing ability, biocompatibility, and stimulation of periapical tissue regeneration. Recently, computer-guided surgery integrating cone-beam computed tomography (CBCT), intraoral scanning, digital planning, and three-dimensional printing has improved surgical precision while minimizing unnecessary bone removal.

This prospective, single-center, single-arm interventional study will enroll 42 patients diagnosed with periapical cysts involving premolar teeth. Eligible participants will undergo guided apicoectomy, cyst enucleation, root-end cavity preparation, and retrograde filling with Mineral Trioxide Aggregate (MTA).

Clinical outcomes will be assessed one week, three months, and six months after surgery. Radiographic healing will be evaluated using cone-beam computed tomography (CBCT) at six months. The study aims to determine the effectiveness and safety of guided apicoectomy with MTA in treating premolar periapical cysts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults diagnosed with a periapical cyst involving a premolar tooth.
  • Diagnosis confirmed by clinical examination and CBCT.
  • Histopathological confirmation of periapical cyst after surgery.
  • Root canal treatment completed with acceptable obturation quality.
  • Tooth considered restorable.
  • No previous apicoectomy on the study tooth.
  • Able to provide written informed consent.

排除标准

  • Uncontrolled systemic diseases.
  • Coagulation disorders.
  • Uncontrolled diabetes mellitus.
  • Active malignancy receiving radiotherapy.
  • Severe cardiovascular disease contraindicating surgery.
  • Vertical root fracture.
  • Grade IV tooth mobility.
  • Allergy to local anesthetics or study materials.
  • Previous surgery for recurrent periapical cyst at the study site.
  • Inability to comply with follow-up schedule.

结局指标

主要结局

Treatment Success Rate

时间窗: 6 months after surgery

The treatment success rate will be assessed 6 months after surgery based on predefined clinical and radiographic success criteria. Success is defined as the absence of clinical signs and symptoms together with evidence of bone healing on cone-beam computed tomography (CBCT).

次要结局

  • Number of Participants With Good Clinical Healing at 1 Week(1 week after surgery)
  • Number of Participants With Good Clinical Healing at 3 Months(3 months after surgery)
  • CBCT Bone Healing Score at 6 Months(6 months after surgery)
  • Number of Participants With Postoperative Complications(1 week, 3 months, and 6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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