| CTRI Number |
CTRI/2024/12/078598 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Whether maintenance of apical patency has an effect on post operative pain |
|
Scientific Title of Study
|
To evaluate whether maintenance of apical patency has an effect on post operative pain in symptomatic irreversible pulpitis 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 Sonal Mukhraiya |
| Designation |
MDS (Postgraduate) |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room NO 7
Department of Conservative Dentistry and Endodontics
ITS Dental College Hospital and Research Centre
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9149378269 |
| Fax |
|
| Email |
mukhraiyasonal01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room NO 7
Department of Conservative Dentistry and Endodontics
ITS Dental College Hospital and Research Centre
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room NO 7
Department of Conservative Dentistry and Endodontics
ITS Dental College Hospital and Research Centre
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College Hospital and Research Centre, Knowledge Park III, Greater Noida, Uttar
Pradesh- 201310, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
Room No 7 Department of Conservative Dentistry and Endodontics
ITS Dental College Greater Noida Uttar Pradesh-201310 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 |
| Dr Sonal Mukhraiya |
ITS Dental College, Greater Noida |
Room No 7 Department
of Conservative
Dentistry and
Endodontics I.T.S
Dental College Hospital
and Research Centre
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9149378269
mukhraiyasonal01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College Hospital and Research Centre Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non patency group |
This group will include the patients in which apical patency will not be maintained. |
| Intervention |
Patency Group |
This group will include the patients in which patency filing will be done once or twice to maintain the apical patency during the biomechanical preparation of the involved tooth. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Single rooted teeth with symptomatic irreversible pulpitis.
2.Patients older than 18 years of age.
|
|
| ExclusionCriteria |
| Details |
1.Patients having periapical lesion.
2.Patients on preoperative analgesics and antibiotics within past one month.
3.Severely damaged teeth; teeth with root resorption ; root fracture or ankylosis; bruxism.
4.Re treatment cases.
5.Immunocompromised patients, pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the effect of maintaining apical patency on post operative pain in symptomatic irreversible pulpitis cases. |
Postoperative pain scores will be recorded on Visual Analog pain rating scale by the patients preoperatively, at 24 hrs and at 48 hrs.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check whether maintaining apical patency leads to lesser incidence of post operative pain in symptomatic irreversible pulpitis cases
|
Postoperative pain scores will be recorded on Visual Analog pain rating scale by the patients preoperatively, at 24 hrs & at 48 hrs. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Tp The purpose of this study is to compare pain reduction in patients with symptomatic irreversible pulpitis by maintaining or not maintaining apical patency. This clinical study will be conducted in the Department of Conservative Dentistry and Endodontics, I.T.S. Dental College, Hospital and Research Centre, Greater Noida(U.P). A total number of 30 patients reporting to the O.P.D. of Department of Conservative Dentistry and Endodontics will be selected according to the inclusion and exclusion criteria. Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. 30 patients will be randomly allocated into 2 groups of 15 patients each i.e patency (Group A) and non-patency (Group B). Postoperative pain scores will be recorded on Visual Analog pain rating scale by the patients preoperatively, at 24 hrs and at 48 hrs. Thereafter, the patients will be recalled for oburation. |