| CTRI Number |
CTRI/2022/01/039105 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
15/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [root canal treatment] |
| Study Design |
Other |
|
Public Title of Study
|
pain assesment after treatment |
|
Scientific Title of Study
|
EFFECT OF NOVEL ENDODONTIC IRRIGANTS ON POSTOPERATIVE PAIN AFTER SINGLE VISIT ENDODONTIC THERAPHY: 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 |
Mosali sai karthik |
| Designation |
postgraduate student |
| Affiliation |
Drs. Sudha and nageswara rao siddhartha institute of dental sciences |
| Address |
Drs.Sudha and nageswara rao siddhartha institute of dental sciences. Department of conservative dentistry and endodontics. room no: 7 .chinaoutpalli, gannavaram mandal.
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
8333999495 |
| Fax |
|
| Email |
saikarthik869@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
drjravikumar |
| Designation |
proffesor |
| Affiliation |
Drs. Sudha and nageswara rao siddhartha institute of dental sciences |
| Address |
Drs.Sudha and nageswara rao siddhartha institute of dental sciences, department of conservative dentistry and endodontics. room no 7,chinaoutpalli, gannavaram mandal, krishna district.
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
drjravikumar |
| Designation |
proffesor |
| Affiliation |
Drs. Sudha and nageswara rao siddhartha institute of dental sciences |
| Address |
Drs.Sudha and nageswara rao siddhartha institute of dental sciences, department of conservative dentistry and endodontics. room no 7,chinaoutpalli, gannavaram mandal, krishna district.
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs. sudha and nageswara rao siddhartha institute of dental sciences. chinnaoutpally, gannavaram, krishna district, andhra pradesh. |
|
|
Primary Sponsor
|
| Name |
kushala ganga bhavani gunnam and M sai karthik |
| Address |
Drs. sudha and nageswara rao siddhartha institute of dental sciences. chinnaoutpally, gannavaram, krishna district, andhra pradesh. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Myself |
Drs. sudha and nageswara rao siddhartha institute of dental sciences. chinnaoutpally, gannavaram, krishna district, andhra pradesh. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Msai karthik |
Drs Sudha and nageswara rao institute of dental sciences |
conservative dentistry and endodontics. room no: 7.
Krishna
ANDHRA PRADESH |
8333999495
saikarthik869@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 |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qmix 2 in 1 and octenidine dihydrochloride |
irrigant for root canal treatment
|
| Comparator Agent |
sodium hypochlorite |
irrigant used in root canal treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patient requiring endodontic therapy.
Teeth that were diagnosed with symptomatic irreversible pulpitis/apical periodontitis.
Patients with pain score ranging from moderate to severe (3–10) on a visual analog scale (VAS) (0–10). |
|
| ExclusionCriteria |
| Details |
Patient who are medically compromised.
Pregnant patients.
Teeth with incomplete apex formation.
Teeth with calcified canals.
Sinus opening.
Periapical abscess.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of postoperative pain after |
12, 24, 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| analgesic consumption |
2 days |
|
|
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 4 |
|
Date of First Enrollment (India)
|
04/01/2022 |
| Date of Study Completion (India) |
05/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
patient with irreversible pulpitis will be included and root canal treatment will be done with irrigants qmix, octenidine dihydrochloride and qmix 2 in 1 and postoperative pain will be assed after 12,24,48 hrs. |