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临床试验/CTRI/2025/04/084202
CTRI/2025/04/084202招募中3 期

Comparative CBCT Based Outcome of Single and Multi Visit Non Surgical Endodontic Therapy Performed in Teeth with Chronic Apical Abscess A Randomized Clinical Trial

Debalina Dasgupta1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
52
试验地点
1
主要终点
To evaluate the Clinical and Radiographic Outcome in Teeth with Chronic Apical Abscess Treated in:

研究概览

简要总结

Chronic apical abscess is an inflammatory response to pulpal infection and necrosis, typically charaterized by a gradual onset, minimal or absent discomfort and an intermittent dischargevof pus through an associated sinus tract, Radiographically, this abscess often present with signs of osseous destruction, such as a radiolucency.

According to Sathorn et al. in 2005, approximately 70% of endodontist treat these cases with single visit non surgical endodontic therapy. Single visit non surgical endodontic therapy gained popularity due to several advantaged including reduced flare up, convenience, improved patient acceptance and better practice management (Walton & Fouad, 1992; Imura & Zuolo 1995). However, teeth with chronic apical abscess and sinus tract exhibit a complex infectious pattern in the apical root canal sysytem and periapical lesion, often involving biofilms (Ricucci D, 2018). Mechanical debridement combined with antibacterial regimen using 0.5% sodium hypochlorite has been shown to render 40-60% of treated teeth bacteria negative (Bystrom & Sjogren et al. 1997).

A recent retrospective study by Artaza et al in 2021 reported a success rate of 79.3% for single visit treatment of cases with sinus tract, indicating that 2 out of 10 cases has failed. The present of sinus tract in a tooth with long standing infection can negatively influence the resolution of apical periodontitis, thereby increasing the likelihood of treatment failure. Moreover, in chronic cases, due to the deeper penetration of microbiota into the root canal, effective disinfection cannot be achieved in a single visit. Additionally, dressing the canal with calcium hydroxide for one week can increase the percentage of bacteria free teeth to approximately 70% (Law & Messer, 2004). Given that this regimen further reduces bacterial load, it can be hypothesized that multiple visit treatment, incorporating calcium hydroxide dressing between appointments, may yield higher healing rates compared to single visit treatment without calcium hydroxide dressing in teeth with chronic apical abscess.

Therefore, to solve the dilemma for management strategy for chronic apical abscess there is a compelling need for well designed clinical trials to evaluate whether it should be treated with single or multi (two) visit. The impact of single or multi (two) visit non surgical endodontic therapy using Cone Beam Computed Tomography (CBCT)  in cases of chronic apical abscess has not been studied previously in the literature. Hence, this study aims to conduct a Randomized Clinical Trial (RCT) following CONSORT guidelines, evaluating the CBCT based outcome of single and multi (two) non surgical endodontic therapy performed in teeth with chronic apical abscess.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Posterior maxillary & mandibular teeth with chronic apical abscess that is with a presence of intra oral sinus tract Radiographic evidence of established radiolucent lesion Teeth should be restorable Either gender belonging to 18 to 65 years of age group Teeth with necrotic pulp confirmed by pulp test Patients without significant systemic disease.

排除标准

  • Intra oral sinus in attached gingiva that is Suggestive of vertical root fracture Teeth without associated intra oral sinus tract Teeth with fracture, subgingival caries and poor periodontal health Patients with systemic conditions which could compromise the healing Patients not willing to participate in the study.

结局指标

主要结局

To evaluate the Clinical and Radiographic Outcome in Teeth with Chronic Apical Abscess Treated in:

时间窗: 6 months and 1 year

a. Single visit non surgical endodontic therapy

时间窗: 6 months and 1 year

b. Multi (two) visit non surgical endodontic therapy

时间窗: 6 months and 1 year

次要结局

  • a. To establish the prevelance of teeth with chronic apical abscess(b. To establish the position of intraoral draining sinus in teeth with chronic apical abscess (buccal or lingual or palatal), Site of sinus, number of sinus, status of sinus (active drainage versus no drainage))

研究者

发起方
Debalina Dasgupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Debalina Dasgupta

Student

研究点 (1)

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