| CTRI Number |
CTRI/2025/03/083165 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Factors effecting post operating pain following
Single Visit Endodontics |
|
Scientific Title of Study
|
Physiological and Pathological Predictive factors for the incidence of post-operative pain following
Single Visit Endodontics: A Clinical 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 Sumit singh |
| Designation |
Post graduate |
| Affiliation |
Army college of dental sciences |
| Address |
Room no 9 PG clinic, ARMY COLLEGE OF DENTAL SCIENCES, Secunderabad Telangana 500087
JJ NAGAR PO, CHENNAPUR-CRPF ROAD
Secunderabad Telangana 500087
Medchal
TELANGANA
500087
India |
| Phone |
08074438861 |
| Fax |
|
| Email |
shekhawat.sumit95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha mehra |
| Designation |
Reader |
| Affiliation |
ARMY COLLEGE OF DENTAL SCIENCES |
| Address |
Room no 9 PG clinic, ARMY COLLEGE OF DENTAL SCIENCES, Secunderabad Telangana 500087
JJ NAGAR PO, CHENNAPUR-CRPF ROAD
Secunderabad Telangana 500087
Medchal
TELANGANA
500087
India |
| Phone |
9398825403 |
| Fax |
|
| Email |
dr.nehamehra86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit singh |
| Designation |
Post graduate |
| Affiliation |
Army college of dental sciences |
| Address |
Room no 9 PG clinic, ARMY COLLEGE OF DENTAL SCIENCES, Secunderabad Telangana 500087
JJ NAGAR PO, CHENNAPUR-CRPF ROAD
Secunderabad Telangana 500087
Medchal
TELANGANA
500087
India |
| Phone |
08074438861 |
| Fax |
|
| Email |
shekhawat.sumit95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 9 PG clinic, ARMY COLLEGE OF DENTAL SCIENCES, Secunderabad Telangana 500087 |
|
|
Primary Sponsor
|
| Name |
Dr Sumit singh |
| Address |
Room no 9, pg clinic,Departement of conservative dentistry and endodontics, ARMY COLLEGE OF DENTAL SCIENCES
JJ NAGAR PO, CHENNAPUR-CRPF ROAD, SECUNDERABAD Telangana 500087 |
| Type of Sponsor |
Private medical college |
|
|
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 Sumit singh |
Army college of dental sciences |
Room no 9, pg clinic,Departement of conservative dentistry and endodontics,
Medchal
TELANGANA |
08074438861
shekhawat.sumit95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMY COLLEGE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic irreversible pulpities and symptomatic apical periodontities |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, (2) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-60 years
Patients who have signed the consent
Symptomatic/asymptomatic irreversible pulpitis
Symptomatic/asymptomatic apical periodontitis
Periapical pathology
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Failure to obtain authorization from patients or the presence of accidents or complications during
treatment
Obliterated canals
Periodontally compromised teeth
Inability to achieve apical patency in any canal
Swelling
Endodontic emergency
Patient with Temporomandibular joint pain
Patient having premedication (analgesia and antibiotic)
Non-surgical retreatment cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| identification of parameters causing pain following single visit root canal |
6hr, 12hr,24hr,48hr,72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| identification of parameters causing pain following single visit root canal |
6hr, 12hr,24hr,48hr,72hrs |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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)
|
25/04/2025 |
| 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="1"
Months="0"
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
|
Patient reporting to opd Eligibility criteria will be checked based on exclusion and inclusion list and an informed consent will be taken from patients included in the study and patients will be informed about the treatment procedure. Assessment of preoperative pain predictors will be done.Case history will be taken. Any medical conditions to patient will be evaluated Pre-operative RVG will be taken. Local anaesthetics (lidocaine hydrochloride and epinephrine 1:100 000) will be injected Access will be prepared with an endo access bur NO 3 (Dentsply), using an air turbine handpiece and under water coolant. The affected tooth will be isolated with a rubber dam. Working length will be determined and cleaning and shaping will be done using protaper gold rotary file system Cleaning and shaping of the root canal till size F3 will be done (protaper gold rotary file system). Radiograph will be taken to check whether file and gutta ourcha cone is beyond or at apex. Cleaning Will be performed with 5% NAOCL AND SALINE solution will be used as final irrigant. Apical patency will be maintained throughout shaping and cleaning procedures with a size 10 k-file, passed 1 mm beyond the working length AH plus sealer will be placed into the canal using the master cone (having the same size as the apical file) as a carrier and obturation will be done. Post endo restoration will be done. Post operative pain will be recorded on visual analogue scale After treatment, 6 hours after treatment, 12 hours after treatment, 24 hours after treatment, 48 hours after treatment, 72 hrs |