跳至主要内容
临床试验/CTRI/2024/10/075706
CTRI/2024/10/075706尚未招募3 期

EVALUATION OF 3.8 PERCENTAGE SDF, MTAD AND 1 PERCENTAGE NaOCl AS ROOT CANAL IRRIGANTS AGAINST E. faecalis IN PULPECTOMIZED PRIMARY TEETH: A CLINICAL TRIAL

Dr Murshid Babu P1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
To analyze and compare anti-microbial effectiveness of 3.8% SDF, MTAD, and 1% NaOCl in pulpectomised primary root canals.

研究概览

简要总结

Primary teeth are vital for a child’s dental and facial development, serving important functions like chewing, speech, and maintaining occlusion until permanent teeth emerge. However, conditions such as dental caries can progress to irreversible pulpitis or pulp necrosis, often accompanied by abscess formation, which are common in pediatric dentistry. In some cases, primary teeth may exhibit signs of both simultaneously. The presence of accessory canals further complicates matters by allowing infective agents to spread into bone marrow spaces and around the developing tooth, undermining the success of endodontic therapy. Inadequate cleaning can result in the persistence of microorganisms and their byproducts, significantly increasing the risk of treatment failure. Thorough removal of pulpal tissues, dentinal debris, and viable microorganisms is vital in endodontic treatment. Complete elimination of microbes is necessary for successful therapy. Inadequate removal can lead to persistent inflammation, hindering healing and compromising treatment effectiveness. Meticulous cleaning and disinfection are essential for optimal outcomes.2 While sufficient instrumentation and irrigation with NaOCl can reduce bacterial counts, but they may not fully eliminate E. faecalis from the root canal.3In cases of post-endodontic therapy pain and infection, E. faecalis is frequently identified,With the prevalence rates reaching up to 90%.This microorganism, characterized as non-fastidious and therapy-resistant, poses challenges in treating infected root canals.Intracanal irrigants play a crucial role in enhancing mechanical debridement by facilitating debris removal, tissue dissolution, and disinfection if canals. The intricate internal anatomy of primary teeth emphasizes the importance of efficient irrigation for thorough cleaning and disinfection.Past efforts to eliminate E. faecalis biofilm with traditional irrigants have been limited. Despite the use of conventional disinfectants and medicaments, achieving and maintaining sterilization of root canals has remained challenging. Intracanal irrigation using a 3.8% w/v solution of SDF, a diluted variant of the SDF used for root canal treatment, has shown promise. Research indicates that 3.8% SDF exhibits antibacterial properties against E. faecalis biofilm and can effectively reduce bacteria as a root canal irrigant. SDF has a high capacity for fluoride release and anti-cariogenic properties, which make it effective for pediatric dentistry. MTAD (a mixture of tetracycline isomer, an acid, and a detergent) has been introduced by Torabinejad and Johnson, is a disinfectant for the root canal system. It consists of a 3% doxycycline aqueous solution, acting as a broad-spectrum antibiotic; 4.25% citric acid, serving as a demineralizing agent; and 0.5% polysorbate 80 detergent (Tween 80). Studies have shown MTAD’s clinical effectiveness and biocompatibility as an endodontic irrigant, equivalent to NaOCl.Sodium hypochlorite (NaOCl), commonly used in root canal treatment, effectively dissolves organic substances but has drawbacks. Its advantages include affordability and organic dissolution capability. However, drawbacks of NaOCl include cytotoxicity, foul odor, clothing bleaching, metal corrosion, incomplete bacterial eradication, smear layer retention, dentin property alteration, and reduced antimicrobial effectiveness over time due to exposure to oxygen, room temperature, and light. So, this study will be aimed to assess and compare the efficacy of 3.8% SDF, MTAD, and 1 % NaOCl as irrigants against Enterococcus faecalis in root canals of pulpectomized primary teeth through an in vivo investigation.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged 3 to 8 years requiring pulpectomy for primary molars diagnosed with irreversible pulpitis.
  • No notable medical conditions present.
  • No exposure to antibiotics within the preceding three months.
  • Primary teeth with sufficient coronal and at least two-thirds root structure.
  • Absence of sinus tracts and pathological root resorption.

排除标准

  • Patients who have taken antibiotics within three months.
  • Patients diagnosed with any systemic diseases.
  • Patients with non-restorable teeth, perforated pulpal floors, excessive mobility, or pathological root resorption.

结局指标

主要结局

To analyze and compare anti-microbial effectiveness of 3.8% SDF, MTAD, and 1% NaOCl in pulpectomised primary root canals.

时间窗: Baseline

次要结局

  • Quantitative assessment of E. faecalis in the root canals of pulpectomized primary molars after extirpation of pulp as baseline.(Quantitative assessment of E. faecalis post irrigation using 3.8% SDF, MTAD and 1% NaOCl as irrigants in the distal root of pulpectomized primary teeth.)

研究者

发起方
Dr Murshid Babu P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Murshid Babu P

KVG Dental college and hospital

研究点 (1)

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