| CTRI Number |
CTRI/2024/12/077911 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
comparative evaluation of different sealers on post operative pain and peri apical healing in apical periodontitis cases |
|
Scientific Title of Study
|
Effect of different sealers on post operative pain and peri apical healing in apical periodontitis cases: An in-vivo study
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirtika Muktawat |
| Designation |
MDS (Postgraduate student) |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics,
I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3,
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8439474872 |
| Fax |
|
| Email |
kirtika1209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics,
I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3,
Greater Noida - 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8439474872 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics,
I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3,
Greater Noida - 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8439474872 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE,
Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics,
I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3,
Greater Noida - 201308, Uttar Pradesh, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Kirtika Muktawat |
I.T.S DENTAL COLLEGE, GREATER NOIDA |
Room no.7, Department of Conservative dentistry and Endodontics,
I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3,
Greater Noida - 201308, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH |
8439474872
kirtika1209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutionalethicscommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient with asymptomatic/symptomatic apical periodontitis with periapical radiolucency more than 2mm
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
gold standard sealer |
ah plus considered as gold standard endodontic sealer in literature. so this study is to compare and evaluate the pain and peri apical healing of ah plus versus other endodontic sealer. |
| Intervention |
use of different endodontic sealers |
The choice of root canal sealer plays a crucial role in periapical healing and post operative pain in cases of apical periodontitis. Different types of sealers can affect healing rates, inflammation levels, and overall clinical outcomes in various ways. this study to compare the effect of Bioceramic, Resin based and MTA based sealers on post operative pain and peri apical healing.
Group 1: AH plus(Dentsply)
Group 2: Bio C(Angelus)
Group 3: MTA Plus(Prevest)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted tooth
Patient with asymptomatic/symptomatic apical periodontitis with periapical radiolucency more than 2mm
Age 18-60 years
|
|
| ExclusionCriteria |
| Details |
Multi rooted tooth
Re RCT cases
Patients on Immunosuppresive drugs/systemic diseases
Inability to reach full working length/ calcified canals
Tooth with draining sinus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of Bioceramic, Resin based and MTA based sealers on post operative pain and peri apical healing. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the best endodontic sealer to be used in case of apical periodontists for fast healing of periapical lesion & minimum post operative pain |
at the end of the study duration which is 3 months & 3months follow up period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Apical periodontitis is characterized by localized
inflammation of periapical tissues resulting from pulp disease, with potential
causes including the progression of dental caries, trauma, or operative dental procedures.
Postoperative pain is a significant clinical outcome
influenced by various treatment-related factors. These include maintaining the
working length to the apical constriction, the duration and technique of
endodontic treatment (whether completed in a single or multiple visits), and
the type of endodontic sealer used for obturation.
Periapical healing involves the intricate interplay between
osteoclasts and osteoblasts, resulting in the structural and functional
replacement of bone. This process is influenced by both intrinsic and extrinsic
mechanisms of the host. A local factor affecting the healing of periapical
tissues is the root canal sealer, which can interfere with the process by
leaching through the apical foramen and lateral canals.
The study will be done to evaluate and compare the effect of Bioceramic, Resin based and MTA based sealers on
post operative pain and peri apical healing. The forthcoming clinical study
will be carried out within the Department of Conservative Dentistry and
Endodontics at I.T.S. Dental College, Hospital, and Research Centre in Greater
Noida,Uttar Pradesh. A total
number of 30 patients will be selected from the O.P.D of Department of
Conservative Dentistry and Endodontics according to inclusion and exclusion
criteria. Inclusion criteria: single rooted tooth, Patient with asymptomatic/symptomatic apical
periodontitis with periapical radiolucency more than 2mm, Age 18-60 years. Exclusion criteria: Multi
rooted tooth, Re RCT cases,Patients
on Immunosuppresive drugs/systemic diseases, Inability to reach full working
length/ calcified canals, Tooth with draining sinus, Multi rooted tooth,Re RCT cases,Patients on Immunosuppresive
drugs/systemic diseases, Inability to reach full working length/ calcified
canals, Tooth with draining sinus. The selected patients will be further
divided into 3 groups: Group 1: AH
plus(Dentsply), Group 2: Bio
C(Angelus), Group 3: MTA
Plus(Prevest). After biomechanical preparation, the canals will be dried using
sterile paper points according to corresponding taper and freshly mixed calcium
hydroxide paste will be placed into the prepared canals using a lentulospiral. The patients will be
recalled after a week and patients who will be asymptomatic exhibiting a VAS
Score of 0, will be obturated. Assessment postoperative pain will be done at an
interval of 24 hrs, 48 hrs, 72 hrs,7 days, at rest and while biting, using the
VAS scale. The number of analgesic pills that had been taken by the patient at
each follow-up period, and will be recorded on patient’s chart. Assessment of
peri apical healing will be done at an interval of 1 month, 3 months and 6
months, with help of intra oral radiograph.
|