| CTRI Number |
CTRI/2023/05/053313 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of postoperative pain after using two root canal sealers along with irrigating needles in symptomatic irreversible pulpitis mandibular molars - A clinical trial |
|
Scientific Title of Study
|
Evaluation and comparison of bio-ceramic and resin based sealer along with two types of irrigating needles on post operative pain and quality of life in mandibular molar teeth with symptomatic irreversible pulpitis – A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yasmeen Mohammed Azeem |
| Designation |
PG Student |
| Affiliation |
Narayana Dental College And Hospital, Nellore |
| Address |
Room no 4, Department of Conservative Dentistry and Endodontics, Narayana Dental College And Hospital, Chintareddypalem, Nellore, AP.
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
8121117616 |
| Fax |
|
| Email |
yasmeenazeem1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kiranmayi Govula |
| Designation |
Associate Professor |
| Affiliation |
Narayana Dental College And Hospital, Nellore |
| Address |
Room no 4, Department of Conservative Dentistry and Endodontics, Narayana Dental College And Hospital, Chintareddypalem, Nellore, AP.
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9440932608 |
| Fax |
|
| Email |
govulakiranmayi24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yasmeen Mohammed Azeem |
| Designation |
PG Student |
| Affiliation |
Narayana Dental College And Hospital, Nellore |
| Address |
Room no 4, Department of Conservative Dentistry and Endodontics, Narayana Dental College And Hospital, Chintareddypalem, Nellore, AP.
ANDHRA PRADESH
524002
India |
| Phone |
8121117616 |
| Fax |
|
| Email |
yasmeenazeem1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 4, Department of Conservative Dentistry and Endodontics, Narayana Dental College And Hospital, Chintareddypalem, Nellore, AP.
|
|
|
Primary Sponsor
|
| Name |
YASMEEN MOHAMMED AZEEM |
| Address |
Room no 4, Department of Conservative Dentistry and Endodontics, Narayana Dental College And Hospital, Chintareddypalem, Nellore, AP.
Nellore
ANDHRA PRADESH
524002
India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Yasmeen Mohammed Azeem |
Narayana dental college and hospital |
Room no 4, Department of Conservative Dentistry and Endodontics, Narayana Dental College And Hospital, Chintareddypalem, Nellore, AP.
Nellore
ANDHRA PRADESH
524002
India
Nellore
ANDHRA PRADESH |
8121117616
yasmeenazeem1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| narayana institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic irreversible pulpitis teeth |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio-ceramic root canal sealer |
Bio-ceramic materials can be classified as bioinert,bioactive or biodegradable according to the interaction with surrounding tissues and this material will be used as an endodontic sealer in root canal treated tooth |
| Comparator Agent |
Resin based root canal sealer |
Resin sealers allow resin tag penetration into dentinal tubules and facilitate a fluid-proof seal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients with symptomatic irreversible pulpitis (mandibular molar).
b.Healthy patients of age group between 18-55 yrs.
c.Patients with preoperative pain scores which will vary from moderate to severe pain on a visual analog scale (VAS).
d.Patients who will have the ability to understand and to use the pain scale.
|
|
| ExclusionCriteria |
| Details |
•Patients with any uncontrolled systemic diseases.
•Retreatments of root canals.
•Teeth with immatureopen apex.
•Patients who initiated root canal treatment in other clinics.
•Patients who has taken analgesic or anti-inflammatory drugs within the last 12 hours.
•Patients with known allergy to local anaesthesia, sodium hypochlorite and chlorhexidine.
•Pregnant and lactating mothers.
•Patients who are unable or unwilling to complete the pain questionnaires.
•Patients who are unwilling to sign consent for endodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain evaluation using visual analogue scale. |
6, 24, 48, 72 hours and on 7th day after the endodontic treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life assessment |
7th day after root canal treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
31/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bio-ceramic
materials have shown to improve the treatment outcome by promoting the
differentiation of odontoblasts and by releasing biologically active
substances. Postoperative pain is multifactorial, so it is very difficult to
consider every factor potentially involved in its aggravation or diminution.
So, this trial is being conducted to evaluate and compare the postoperative
pain by using different irrigation needles (conventional and side vented) for
irrigation and bio-ceramic and resin based sealers for obturation. |