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
|
|
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
|
|
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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