| CTRI Number |
CTRI/2024/01/061692 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of various Irrigation protocols and Irrigating needles on Postoperative Pain and Oral Health related Quality life – A Randomized Clinical Trial |
|
Scientific Title of Study
|
Effect and Comparison of two Different Irrigation Protocols and two Irrigating Needles on Post Operative Pain and Oral Health Related Qualityof Life (OHQOL) after Endodontic Treatment – A Randomised Clinical Trial. |
| 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.Gone Amarnath |
| Designation |
post graduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Narayana Dental College And Hospital
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
7702448893 |
| Fax |
|
| Email |
amar4229@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gone Amarnath |
| Designation |
post graduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Narayana Dental College And Hospital
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
7702448893 |
| Fax |
|
| Email |
amar4229@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiranmayi G |
| Designation |
associate professor |
| Affiliation |
narayana dental college and hospital |
| Address |
department of conservative dentistry and endodontics
narayana dental college and hospital
nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
7702448893 |
| Fax |
|
| Email |
govulakiranmayi24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gone amarnath
Narayana dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Gone Amarnath |
| Address |
Narayana Dental College And Hospital
Nellore |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| DrGone Amarnath |
Narayana Dental College and Hospital Nellore |
Department of conservative dentistry and endodontics
OPD Room no : 4
Nellore
ANDHRA PRADESH |
7702448893
govulakiranmayi24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Dental College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic irreversible pulpitis with symptomatic apical periodontitis |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Root canal irrigation using Sodium hypochlorite and Ethylene diamine tetra acetic acid using conventional needles |
Root canal irrigation using Sodium hypochlorite and Ethylene diamine tetra acetic acid using conventional needles for two minutes |
| Intervention |
Root canal irrigation using Sodium hypochlorite and Hydroxyethylidene Bisphosphonate alternatively using double-side vented irrigation needles |
Root canal irrigation using Sodium hypochlorite and Hydroxyethylidene Bisphosphonate alternatively for two minutes using double-side vented irrigation needles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Systemically healthy patient (ASA I or II),
2 Mandibular molar teeth with clinical manifestations of symptomatic irreversible pulpitis
3 Mandibular molars with symptomatic apical periodontitis with widening of lamina dura
|
|
| ExclusionCriteria |
| Details |
•Systemic complications of grades ASA III, IV, and V
•Pregnancy and nursing
•Asymptomatic irreversible pulpitis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
assessing post operative pain by using a visual analog scale and Quality of life by using ohip 14 questionnaire
|
assessing post-operative pain by using a visual analog scale at baseline, 6 hours 24 hours 48 hours 72 hours and 7th day
Quality of life by using OHIP 14 questionnaire on 7th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life by using OHIP 14 QUESTIONAIRE
|
After 1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| 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="8"
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
|
During endodontic treatment,
Conventional irrigation with NaOCl& EDTA, forms precipitate and decreases
surface hardness of root dentin hindering NaOCl action. To overcome the above disadvantage
, combination of NaOCl& HEBP(1-Hydroxyethylidene-1, 1-Bisphosphonate) used
which does not alters the NaOCl action and surface hardness of root dentin.
In conventional needle irrigation, the chances of
apical extrusion of debris and irrigants are more which is the most important
factor in causing post operative pain.
Hence to overcome the Post operative pain, newer advances like double side
vented needles were introduced. Hence, a combination of new irrigation protocol
using NaOCl + HEBP(1-Hydroxyethylidene-1, 1-Bisphosphonate) and double side
vented irrigation needle tips might be helpful in reducing the post operative
pain and improves the oral health quality of life. |