| CTRI Number |
CTRI/2021/11/038013 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
09/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post-Operative Quality Of Life In Patients Undergoing Root Canal Therapy Using Various Final Irrigation Solutions |
|
Scientific Title of Study
|
Evaluation Of Post-Operative Quality Of Life In Patients Undergoing Two Visit Root Canal Therapy Following Final Irrigation With Cold Saline Or Diclofenac Sodium Solution -A Prospective Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAVITHRA S |
| Designation |
PG STUDENT |
| Affiliation |
Sri ramakrishna dental college |
| Address |
Sri ramakrishna dental college
department of conservaative dentistry and endodontics
Room no 202
SNR road, Nava India , Peelamedu
SNR road, Nava India , Peelamedu
Coimbatore
TAMIL NADU
641006
India |
| Phone |
09025430567 |
| Fax |
|
| Email |
pavithrasivaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subha Anirudhan |
| Designation |
Professor |
| Affiliation |
Sri ramakrishna dental college |
| Address |
Sri ramakrishna dental college
department of conservative dentistry and endodontics
room no 202
SNR road, Nava India , Peelamedu
SNR road, Nava India , Peelamedu
Coimbatore
TAMIL NADU
641006
India |
| Phone |
9786078340 |
| Fax |
|
| Email |
subhaanirudhan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SIDHARTH SIVAKUMAR |
| Designation |
PG STUDENT |
| Affiliation |
Sri ramakrishna dental college |
| Address |
Sri ramakrishna dental college
department of conservative dentistry and endodontics
room no 202
SNR road, Nava India , Peelamedu
SNR road, Nava India , Peelamedu
Coimbatore
TAMIL NADU
641006
India |
| Phone |
9585523510 |
| Fax |
|
| Email |
sidharth.336699@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramakrishna dental college
department of conservative dentistry and endodontics
room no 202
SNR road, Nava India , Peelamedu |
|
|
Primary Sponsor
|
| Name |
Pavithra S Sidharth Sivakumar |
| Address |
Sri Ramakrishna Dental College |
| 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 |
| Pavithra S |
Sri Ramakrishna Dental College And Hospital |
202 room number
Department of conservative dentistry and endodontics
Sri ramakrishna dental college ,
SNR road, Nava India , Peelamedu
Coimbatore
TAMIL NADU |
09025430567
pavithrasivaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hospital 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 |
Cold Saline |
Final Irrigation With Cold Saline Irrigation
dose: cold saline(0.9% W/V)
route of administration:root canal of teeth-intracanal irrigation
frequency:once(final irrigation)
duration inside canal :7 days |
| Intervention |
Diclofenac Sodium |
Final irrigation with Diclofenac sodium
Diclofenac Sodium
Dose-25mg/ml
route of administration:root canal of teeth-intracanal irrigation
frequency:once(final irrigation)
duration inside canal :7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis with or without apical periodontitis (acute or chronic)
Primary root canal treatment in fully matured mandibular molars
Teeth with enough crown structure for adequate isolation
|
|
| ExclusionCriteria |
| Details |
Presence of periapical and periodontal lesions
Teeth with complex root anatomy, resorption, re-treatment and calcifications
Patients with chronic systemic disease and pregnant patients
Patients who received analgesics or antibiotics within the preceding 6 hours before the procedure.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post-Operative Quality of Life(Difficulty in chewing, speaking, sleeping, carrying out daily functions, social relations and overall QoL) and post-operative pain will be evaluated after 24,48,72 hours and 7 days
|
24,48,72, hours and 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain (mean and maximum pain) will be assessed through a visual analogue scale (VAS) |
24,48,72, hours and 7 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
22/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To be published in dental journals after trial is over |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to evaluate the Post-operative Quality of Life in patients undergoing root canal therapy in two-visits following final irrigation with cold saline(2.5°C) or Diclofenac Sodium solution
Outcomes •To evaluate Post-Operative Quality of life using questionnaires •To evaluate post-operative pain using visual analogue scale scoring at 24,48,72 hours and 7days •60 patients reporting with pain divided into two groups by randomization. •Group I (n=30) - final irrigation with cold saline (2.5°C) and group II(n=30) – final irrigation with diclofenac sodium solution, respectively.
STUDY POPULATION: Individuals reporting with pain in teeth and attending the Department of Conservative dentistry and Endodontics of Sri Ramakrishna Dental College and Hospital, Coimbatore will be included in this study. STUDY DESIGN:PROSPECTIVE interventional study
|