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CTRI Number  CTRI/2025/08/093792 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Effect of Green Tea Extract (EGCG) in Reducing Pain Between Root Canal Visits 
Scientific Title of Study   Effectiveness of EGCG in Minimizing Interappointment flareups-A Randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpa Gollaprolu 
Designation  Second Year Post Graduate 
Affiliation  Narayana Dental College and Hospital 
Address  Ist Floor, Department of Conservative and Endodontics
Narayana Dental College and Hospital, Chinthareddypalem
Nellore
ANDHRA PRADESH
524003
India 
Phone  08612313841  
Fax    
Email  shilpamdsendo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Govula Kiranmayi 
Designation  Associate Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Conservative and Endodontics
Narayana Dental College and Hospital, Chinthareddypalem
Nellore
ANDHRA PRADESH
524003
India 
Phone  08612313841  
Fax    
Email  kiranmayi.govula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vandana Raghunath 
Designation  Member Secretary 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Oral Pathology and Microbiology
Narayana Dental College and Hospital, Chinthareddypalem
Nellore
ANDHRA PRADESH
524003
India 
Phone  08612313841  
Fax    
Email  vandanaraghunath@hotmail.com  
 
Source of Monetary or Material Support  
Otto Chemie Pvt. Ltd. Corporate Office: No. 603, 6th Floor, Tardeo AC Market Building 87, Tardeo Road, Mumbai- 400 034. India. 
 
Primary Sponsor  
Name  Dr Shilpa Gollaprolu 
Address  Department of Conservative and Endodontics Narayana dental college Nellore 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpa Gollaprolu  Narayana Dental College  Department of Conservative and ENDODONTICS Narayana Dental College NELLORE Nellore
Nellore
ANDHRA PRADESH 
09494003007

shilpamdsendo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee NDCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calcium hydroxide   Calcium hydroxide as intracanal medicament and to assess interappointment flare ups for a duration of 3 months till the sample size of inclusion criteria is fulfilled. 
Intervention  Epigallocatechin (green tea extract)  Epigallocatechin used as intracanal medicament for assessing interappointment flare ups for a duration of 3 months till the sample size of inclusion criteria is fulfilled. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Symptomatic Irreversible pulpitis with lesion less than 2mm
Teeth with complete root formation
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluation of interappointment flareups after using epigallaocatechin as intracanal medicament using VAS   24 hrs 72hrs and 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
quality of life after rootcanal treatment  24 hrs 72hrs and 7 days 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 mutans in 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.

 

 

 
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