跳至主要内容
临床试验/CTRI/2025/01/078981
CTRI/2025/01/078981招募中Phase 3 4

Healing outcome in nonsurgical root canal treatment versus periapical surgery versus Intentional replantation for management of large periapical lesion of Endodontic origin.

Department of Conservative Dentistry and Endodontics1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
45
试验地点
1
主要终点
To evaluate the clinical and CBCT outcome of

研究概览

简要总结

Large periapical lesion (LPL) of endodontic origin are primarily caused by bacteria and their by-products emanating from the root canal system. These lesions are expected to heal if the source of infection (intracanal bacteria and bacterial-by products) is eradicated. Non-surgical root canal treatment (NSRCT) has a good success rate for management of LCPL. However, NSRCT may require multiple visits. Hence, in many cases surgical intervention may be required. Despite the advances in periapical surgeries, some cases of LPL cannot be managed surgically due to surrounding anatomical or neurovascular structures (e.g.; proximity to the mental nerve or maxillary sinus), or lack of accessibility (e.g.; thick buccal bone, endodontic-periodontal lesion, repair of a palatal radicular groove or extensive root perforation). Moreover, periapical surgery is an invasive procedure which takes long intraoperative time period with possibility of post-operative swelling and pain. Intentional replantation (IR) is defined as a deliberate extraction of tooth, following which the tooth undergoes inspection, endodontic manipulation and repair and is then replanted back into the same socket . Intentional replantation (IR) results in elimination of diseased tissue, removes apical

ramifications and provides a better quality of apical seal due to the improved access and ease of manipulation. IR addresses both intraradicular and extra-radicular infection. In this regard, it offers benefits of both non-surgical endodontic treatment and peri-apical surgery. It offers several advantages with reduced morbidity; less invasive; less technique-sensitive procedure that can potentially be done by general dental practitioners and is more cost-effective. Moreover, IR is done within 15-20 minutes, with very less postoperative complications. The aim of the study is to evaluate and compare the CBCT outcome of non-surgical root canal treatment with intentional replantation and periapical surgery performed for management of maxillary anterior large periapical lesion of endodontic origin.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Radiographically diagnosed with large periapical lesion more than 10mm associated with maxillary anterior teeth.
  • Minimal marginal bone height of 2-3 mm.
  • Acceptable periodontal status (probing depth less than 4mm).

排除标准

  • Patients with systemic conditions which could compromise the healing.
  • Cysts of non-odontogenic origin.
  • Apico-marginal defect.
  • Developmental anomaly of a tooth (palate gingival groove, dilaceration, PCO etc Cervical & External root resorption.
  • Non restorable and teeth with vertical root fractures.
  • Patients not willing to participate in the study.

结局指标

主要结局

To evaluate the clinical and CBCT outcome of

时间窗: Patients evaluated at baseline; after treatment | for 1 week; 1 month and followed up for 6 | months and 1 year

maxillary anterior large periapical lesion of endodontic origin.

时间窗: Patients evaluated at baseline; after treatment | for 1 week; 1 month and followed up for 6 | months and 1 year

a) Treated with intentional replantation with periapical curettage.

时间窗: Patients evaluated at baseline; after treatment | for 1 week; 1 month and followed up for 6 | months and 1 year

b) Treated with periapical surgery.

时间窗: Patients evaluated at baseline; after treatment | for 1 week; 1 month and followed up for 6 | months and 1 year

c) Treated with nonsurgical root canal treatment.

时间窗: Patients evaluated at baseline; after treatment | for 1 week; 1 month and followed up for 6 | months and 1 year

次要结局

  • To identify the prognostic factors affecting the(outcome of large periapical lesion treated with intentional replantation.)

研究者

发起方
Department of Conservative Dentistry and Endodontics
申办方类型
Other [Private Dental College]
责任方
Principal Investigator
主要研究者

Vineeta Nikhil

Subharti Dental College and Hospital/Swami Vivekanand Subharti University

研究点 (1)

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