| CTRI Number |
CTRI/2019/07/020045 [Registered on: 05/07/2019] Trial Registered Prospectively |
| Last Modified On: |
04/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of cold saline irrigation during root canal treatment on postoperative pain in symptomatic teeth |
|
Scientific Title of Study
|
Effect of intracanal cryotherapy on postoperative pain in teeth with symptomatic apical periodontitis: 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 |
Dr Samrita Shrestha |
| Designation |
MDS postgraduate |
| Affiliation |
B.P. Koirala Institute of Health Sciences |
| Address |
Department of conservative dentistry and endodontics, Room No. 8, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
7053
Other |
| Phone |
9779841491991 |
| Fax |
|
| Email |
drsamrita.shrestha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navin Agrawal |
| Designation |
Additional Professor, Head of department |
| Affiliation |
B.P. Koirala Institute of Health Sciences |
| Address |
Department of conservative dentistry and endodontics, Room No. 8, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
7053
Other |
| Phone |
9779841491991 |
| Fax |
|
| Email |
mailingnavin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samrita Shrestha |
| Designation |
MDS postgraduate |
| Affiliation |
B.P. Koirala Institute of Health Sciences |
| Address |
Department of conservative dentistry and endodontics, Room No. 8, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
7053
Other |
| Phone |
9779841491991 |
| Fax |
|
| Email |
drsamrita.shrestha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Samrita Shrestha
MDS postgraduate
Department of conservative dentistry and endodontics, Room No. 8, B.P. Koirala Institute of Health Sciences, Dharan, Nepal |
|
|
Primary Sponsor
|
| Name |
Dr Samrita Shrestha |
| Address |
B.P. Koirala Institute of Health Sciences, Dharan, Nepal |
| Type of Sponsor |
Other [self - Investigator] |
|
|
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 |
| Dr Samrita Shrestha |
B.P. Koirala Institute of Health Sciences |
Department of conservative dentistry and endodontics, Room No. 8, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
|
9779841491991
drsamrita.shrestha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Committee, B.P. Koirala Institute of Health Sciences |
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 |
cold normal saline (2-4 degree centigrade) |
assessment of pain after using cold normal saline as a final irrigant in root canal treatment in symptomatic apical periodontitis |
| Comparator Agent |
room temperature normal saline |
assessment of pain after using room temperature normal saline as a final irrigant in root canal treatment in symptomatic apical periodontitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Nepalese patients older than 18 years of age
2. Only patients presenting with uniradicular teeth with a single canal and a diagnosis of necrotic pulp and symptomatic apical periodontitis
3. Only those patients registering from 4 to 10 on the preoperative NRS will be included
4. Patient who can understand and provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in the study
2. Patients whose forms will be incompletely or inadequately filled out
3. Pregnancy
4. A history of medication for chronic pain
5. Immunocompromised patient
6. Patients with special needs and medical conditions altering the protocol
7. Root canal re-treatment
8. Presence of difficult root canal anatomy
9. Root canals with an extreme curvature [>30]
10. Internal or external resorption
11. Teeth with open apices
12. A radiographically untraceable canal path
13. Any accident or complication occurring during treatment
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of intracanal cryotherapy on postoperative pain in teeth with symptomatic apical periodontitis will be measured as the changes from baseline.
|
6, 12, 24, 48 and 72 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of intracanal cryotherapy and room temperature sterile saline solution as an intracanal irrigant on postoperative pain in different time interval will be measured. |
6, 12, 24, 48 and 72 hours post-operatively |
|
|
Target Sample Size
|
Total Sample Size="68"
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) |
20/07/2019 |
| 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 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)?
|
|
Brief Summary
|
One of the aims of the endodontic therapy is to reduce
postoperative pain and reduce the inflammation. Postoperative pain
following root canal treatment can be embarrassing for the dentist and annoying
for the patient. Despite
acceptable standards of endodontic therapy, occurrence of mild intensity
postoperative pain is a common event. Postoperative
pain is multifactorial yet it can be predicted especially in teeth with pulp
necrosis, preoperative pain and symptomatic apical periodontitis.
One novel way to reverse the inflammatory process and
control pain is cryotherapy. Cryotherapy has reduced the incidence of
postoperative pain and the need for medication in patients as well. In this study, patients who will meet all inclusion criteria and none
of the exclusion criteria will be randomly assigned into two groups by means of
computer generated random number.
Group
I
will be the experimental group that will receive a final irrigation with cold
(2.5°C) sterile
saline solution. Group
II
will be the control group that will receive a final irrigation with sterile
saline solution at room temperature. Root canal treatment will be performed as per the standard protocol. Follow up of subject
will be done at 6, 12, 24, 48 and 72 hours post-operatively. Preoperative and postoperative pain score will recorded following the numeric pain rating score.
|