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临床试验/CTRI/2025/08/093792
CTRI/2025/08/093792招募中3 期

Effectiveness of EGCG in Minimizing Interappointment flareups-A Randomized clinical trial

Dr Shilpa Gollaprolu1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月8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
36
试验地点
1
主要终点
evaluation of interappointment flareups after using epigallaocatechin as intracanal medicament using VAS

研究概览

简要总结

Flare-ups are defined as the occurrence of severe pain and swelling following root canal treatment (RCT), resulting in unscheduled patient appointments. Patients may experience flare-ups in between or after RCT.

The factors responsible for flare-ups are microbial, chemical, and mechanical injuries to the pulp. Additionally, a correlation exists between flare-ups and factors such as gender, age, preoperative pain, tooth type, number of visits, irrigation techniques, and the use of intracanal medicaments.

It has been demonstrated that antibacterial irrigation combined with mechanical instrumentation results in only 50%–70 % of the infected canals being microorganism-free.[3] Therefore, to maximize root canal system disinfection, additional techniques, such as the use of intracanal medications, are necessary. A combination of antibiotic pastes and calcium hydroxide (CH), among other intracanal medicaments (ICMs), is essential to the success of root canal therapy

Calcium hydroxide has long been considered the gold standard intracanal medicament due to its high alkalinity and broad antimicrobial spectrum. However, several studies have highlighted its limitations, particularly against resistant endodontic pathogens such as Enterococcus faecalis and Candida albicans, which can survive in high pH environments. Moreover, calcium hydroxide exhibits limited anti-inflammatory activity and may compromise dentin mechanical properties with prolonged use.2

In contrast, herbal intracanal medicaments offer several advantages. Phytochemicals such as flavonoids, tannins, and polyphenols found in herbal extracts possess potent antimicrobial, anti-inflammatory, antioxidant, and tissue-regenerative properties. These compounds act through multiple mechanisms, including the disruption of bacterial cell walls, inhibition of enzyme activity, and modulation of host immune responses, making them effective against even resistant microorganisms.1

Additionally, herbal medicaments such as Azadirachta indica (neem), Triphala, Curcuma longa (turmeric), Allium sativum (Garlic), and Camellia sinensis (green tea, rich in EGCG) have shown superior biocompatibility and minimal cytotoxicity, making them safe for periapical tissues. Their natural origin also reduces the risk of antibiotic resistance and allergic reactions.3

Given these benefits, herbal alternatives hold significant potential to enhance the antimicrobial efficacy of intracanal treatment, while supporting periapical healing and reducing adverse effects, positioning them as a promising substitute or adjunct to conventional agents, such as calcium hydroxide, in endodontic practice.

 Epigallocatechin-3-gallate (EGCG) is a primary flavonoid compound extracted from green tea leaves, which represents approximately 59% of the total catechins. EGCG is efficacious against Enterococcus faecalis, both in planktonic cells and biofilm, and it is also efficacious at inhibiting the adhesion of Streptococcus mutansin a dose-dependent manner. Furthermore, EGCG also demonstrated potent inhibition of metalloproteinases (MMP), mainly MMP-2 and MMP-9, 17, which are host-derived enzymes associated with the self-degradation of dentin collagen and the progression of dental caries, periodontitis, and apical periodontitis4

 In vitro studies have demonstrated that Epigallocatechin-3-gallate (EGCG), a principal catechin in green tea, possesses potent antibacterial activity against common endodontic pathogens, including Enterococcus faecalis and Candida albicans. It disrupts bacterial cell membranes, inhibits biofilm formation, and reduces microbial adhesion within the root canal system. Importantly, EGCG has shown minimal cytotoxicity to periapical tissues and human periodontal ligament fibroblasts, supporting its biocompatibility as an intracanal medicament. Additionally, its anti-inflammatory and antioxidant properties contribute to the modulation of host immune responses, which may aid in the healing of periapical lesions. These findings support EGCG’s potential as a safe and effective alternative to traditional medications in endodontic therapy.5

This study aims to evaluate the role of EGCG as an herbal intracanal medicament in eliminating or reducing interappointment flare-ups during root canal treatment, thereby contributing to the development of safer, more effective biologically based endodontic protocols.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Symptomatic Irreversible pulpitis with lesion less than 2mm Teeth with complete root formation.

排除标准

  • Tooth with root fractures/resorptions, presence of intraoral and extraoral swelling, and sinus opening.
  • Teeth requiring retreatment and previously accessed teeth.
  • Tooth with primary periodontal and secondary endodontic lesions.
  • Patients who had taken antibiotics within the previous 30 days or who had taken analgesics within the last 24 hours were not accepted.

结局指标

主要结局

evaluation of interappointment flareups after using epigallaocatechin as intracanal medicament using VAS

时间窗: 24 hrs 72hrs and 7 days

次要结局

  • quality of life after rootcanal treatment(24 hrs 72hrs and 7 days)

研究者

发起方
Dr Shilpa Gollaprolu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shilpa Gollaprolu

Narayana Dental College and Hospital

研究点 (1)

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