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CTRI Number  CTRI/2022/07/044319 [Registered on: 26/07/2022] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Influence of a fungus extract on success of root canal treatment 
Scientific Title of Study   Analysis of Periapical Healing following Root Canal Treatment of Single Rooted Permanent Teeth with Periapical Lesion using Pachymic Acid Modified Epoxy Resin Root Canal Sealer: An Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shiza Yezdani 
Designation  I Year Post graduate Student  
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistrty and Endodontics, Out patient department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
Department of Conservative Dentistrty and Endodontics, Out patient department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9791705678  
Fax  044-22492429  
Email  shiza_yezdani@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSMahalaxmi  
Designation  Professor and Head 
Affiliation  SRM Institute of Science and Technology  
Address  Department of Consevative Dentistry and Endodontics, Out patient Department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
Department of Conservative Dentistrty and Endodontics, Out patient department 2nd floor, SRM Dental College Bharathi Salai, Ramapuram. Chennai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax  044-22492429   
Email  reasearchmaha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Vidhya 
Designation  Professor  
Affiliation  SRM Institute of Science and Technology  
Address  Department of conservative and endodontics, Out patient department, 2nd floor, SRM Dental College Bharathi Salai, Ramapuram Chennai TAMIL NADU 600089 India
Department of conservative and endodontics, Out patient department, 2nd floor, SRM Dental College Bharathi Salai, Ramapuram Chennai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9445563355  
Fax  044-22492429   
Email  vidhyas@srmist.edu.in  
 
Source of Monetary or Material Support  
Department of conservative and endodontics out patient department 2nd floor SRM Dental college Bharathi salai Ramapuram Chennai  
 
Primary Sponsor  
Name  SRM Dental College  
Address  Department of Conservative Dentistry and Endodontics (II nd floor) SRM Dental College Bharathi Salai, Ramapuram Chennai- 600 089, Tamil Nadu, India 
Type of Sponsor  Research institution and hospital 
 
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 
Shiza Yezdani  SRM Dental College and Hospital   Department of Conservative Dentistry and Endodontics out patient department 2nd floor Bharathi Salai Ramapuram Chennai TAMIL NADU
Chennai
TAMIL NADU 
9791705678
044-22492429
shiza_yezdani@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Pachymic acid modofied epoxy resin root canal sealer  AH Plus root canal sealer mixed with pachymic acid 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients aged 18-45 years with single-rooted anterior teeth diagnosed with pulp necrosis and apical periodontitis, with PAI score 3 and above and indicated for root canal treatment.
-Patients belonging to ASA (American Society of Anaesthesiologists) Category I and II.
-Patient should not be under medication for the past 24 hours.
 
 
ExclusionCriteria 
Details  Patients who are medically compromised or allergic to drugs
-Pregnant and lactating women
-Periodontally compromised teeth with mobility greater than grade 1
-Teeth with root caries and/or pulp calcifications
-Retreatment cases
-Presence of external or internal root resorption
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pachymic acid incorporated AH Plus as a root canal sealer can help in healing of the periapical lesion within a shorter period of time.  3,6 and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
n/a  n/a 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/07/2022 
Date of Study Completion (India) 16/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Microbial factors and host inflammatory response deleteriously affect the periapical tissues, resulting in the formation of periapical (PA) lesions. Though majority of the periapical lesions heal subsequent to meticulous non-surgical endodontic treatment, iatrogenic errors like inadvertent sealer extrusion could jeopardize healing. Previous studies have highlighted the inflammation-inducing potential of epoxy resin root canal sealer (AH Plus, Dentsply, DeTrey GmbH, Konstanz, Germany) following its extrusion into the periapical tissues. Sealer-induced cytotoxicity results in the induction of an inflammatory response, which in turn causes periapical destruction, alveolar bone resorption, and even loss of tooth. There is a constant search for a biocompatible sealer that is less toxic or nontoxic and less irritating to the periapical tissues. The addition of antioxidants such as N-acetyl L-cysteine and peroxisome proliferator-activated receptor gamma agonists to epoxy resin-based sealers has been shown to reduce oxidative stress and inflammatory reaction induced by these sealers.

Another bio-pharmacologic agent that was found to be effective is pachymic acid (PA), a triterpenoid, extracted from the fruiting body of Fomitopsis nigra mushroom, known to possess anti-inflammatory property. Kim et al, 2013 demonstrated that the antioxidant effect of PA restored cell viability and alkaline phosphatase activity in mouse osteoblast (MC-3T3 E1) cells exposed to AH Plus. Arun et al, 2017 reported that incorporation of PA to AH Plus significantly reduced the cytotoxicity associated with the latter, when tested on L929 mouse fibroblast cells. Preethi et al, 2020 reported that AHP/PA exhibited physicochemical properties that were within the requirements of ISO and with time, showed apical sealing ability that was comparable to AH Plus. But the effect of the addition of PA to AH Plus on periapical healing in teeth with periapical lesions under in vivo conditions has not yet been explored.  

Root canal sealers can play a crucial role when in contact with the periapical tissues causing a localized inflammation with a direct influence on the degree of inflammation based on the composition of the sealer in turn influencing postoperative pain levels. Imaging forms an essential part of endodontics, from diagnosis to long-term assessment of healing outcomes. Studies have referred to the periapical index (PAI) as a scoring system for radiographic assessment of periapical lesions. The PAI represents an ordinal scale of 5 scores ranging from no disease to severe periodontitis with exacerbating features. Hence the benefit of using radiograph with a PAI index in endodontics corresponds to a high accuracy in detecting periapical lesions even in its earliest stages and aiding in differential diagnosis as a non-invasive technique. Postoperative pain usually ranges from 3% to 58% based on the individual’s pain perseverance and stimulus and is considered to be a significant clinical outcome exhibiting a multifactorial response to treatment related factors including the type of endodontic sealer used for obturation. Hence, the aim of this observational study is to evaluate the periapical healing following root canal treatment of single rooted permanent teeth with periapical lesion using pachymic acid modified epoxy resin root canal sealer.

 
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