| CTRI Number |
CTRI/2021/02/030964 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
03/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effect of pretreatment submucosal dexamethasone injection on postoperative pain after endodontic therapy |
|
Scientific Title of Study
|
Effect of pretreatment submucosal dexamethasone injection on post operative endodontic pain: A double blind 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 |
Purna Prasad Sharma |
| Designation |
MDS PG Resident |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Dept. of Conservative Dentistry and
Endodontics, Room no. 8, CODS, BPKIHS,
Dharan-18, Nepal
B.P. Koirala Institute of Health Sciences
Dharan, Nepal
56700
Other |
| Phone |
9847421219 |
| Fax |
|
| Email |
purnaprasadsharma1@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mannu Vikram |
| Designation |
Additional Professor |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Dept. of Conservative Dentistry and
Endodontics, Room no. 8, CODS,BPKIHS,
Dharan-18, Nepal
B.P. Koirala Institute of Health Sciences
Dharan, Nepal
56700
Other |
| Phone |
9852049808 |
| Fax |
|
| Email |
drmannuvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mannu Vikram |
| Designation |
Additional Professor |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Dept. of Conservative Dentistry and
Endodontics, Room no. 8, CODS,BPKIHS,
Dharan-18, Nepal
B.P. Koirala Institute of Health Sciences
Dharan, Nepal
56700
Other |
| Phone |
9852049808 |
| Fax |
|
| Email |
drmannuvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
| BP Koirala Institute of Health Sciences, Dharan-18, Nepal |
|
|
Primary Sponsor
|
| Name |
Purna Prasad Sharma |
| Address |
Dept. of Conservative Dentistry and
Endodontics, Room no. 8, CODS, BPKIHS,
Dharan-18, Nepal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Purna Prasad Sharma |
BP Koirala Institute of Health Sciences |
Dept. of Conservative Dentistry and
Endodontics, Room no. 8, CODS, BPKIHS,
Dharan-18, Nepal
|
9847421219
purnaprasadsharma1@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review committe, BPKIHS Dharan |
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 |
Dexamethasone |
Pretreatment submucosal injection 8mg/2ml |
| Comparator Agent |
Normal Saline |
pretreatment submucosal injection, 2ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Nepalese patients 18 years old or above.
Healthy persons (ASA I or II)
Only patients presenting with decayed tooth with a diagnosis of symptomatic apical periodontitis with clinical history of lingering pain.
Patient who can understand and provide informed consent
Patient who can rate pain according to numeric rating scale
|
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in the study
Patients whose forms will be incompletely or inadequately filled out
Individuals who received any analgesic or anti-inflammatory drugs within the last 12 hours
Pregnant and lactating women
A history of medication for chronic pain
Immunocompromised patient
Patients under corticosteroids
Patients with special needs and medical conditions altering the protocol
Patients with history of sensitivity or adverse reactions to medicines to be used
Root canal re-treatment
Teeth with open apices, Root canals with an extreme curvature [>30°], Internal or external root resorption.
A radiographically untraceable canal path
Any accident or complication occurring during treatment
Anyone having the following diseases: tuberculosis, systemic fungal infections, simple ocular herpes, glaucoma, acute psychosis or psychotic tendencies
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of submucosal injection of dexamethasone on postoperative pain in teeth with symptomatic apical periodontitis will be measured as the changes from baseline at 6h, 12h, 24h, 48h and 72 hours. |
6 hours, 12 hours, 24 hours, 48 hours, 72 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any unscheduled appointment for emergency treatment or any complications such as postoperative swelling will be measured. |
Before 2nd appointment at 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="0"
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 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is the randomized, double blind, placebo controlled, single centered clinical trial evaluating the effect of pretreatment submucosal dexamethasone injection (8mg/2ml) on postoperative endodontic pain in patients (>18yrs) with symptomatic apical periodontitis secondary to irreversible pulpitis.Primary
Objective:
To determine the effect of dexamethasone submucosal injection on post-operative
endodontic pain at different time intervals of 6h, 12h, 24h, 48h and 72hours.
Secondary
Objective:
The
secondary objective will be to assess any unscheduled appointment for emergency
treatment or any complications such as postoperative swelling. Null hypothesis: There is no significant difference in the
reduction of postoperative pain with pretreatment submucosal dexamethasone
injection and saline injection. Primary Outcome Measures:
The effect of submucosal
injection of dexamethasone on postoperative pain in teeth with symptomatic
apical periodontitis will be
measured as the changes from baseline at 6h, 12h, 24h, 48h and 72 hours. Secondary Outcome
Measures: Any unscheduled
appointment for emergency treatment or any complications such as postoperative
swelling will be measured. Total estimated sample size would be 60. |