| CTRI Number |
CTRI/2025/12/098797 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Other (Specify) [IRRIGANT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation Of Post Endodontic Pain Using Two Different Volumes Of Plain Saline |
|
Scientific Title of Study
|
Comparative Evaluation Of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment – An InVivo study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranita Ingle |
| Designation |
student |
| Affiliation |
VSPM DENTAL COLLEGE NAGPUR |
| Address |
VSPM Dental College and Research Center, Digdoh Hingna Nagpur. VSPM Dental College and Research Center, Digdoh Hingna Nagpur. Nagpur MAHARASHTRA 440019 India |
| Phone |
7499760391 |
| Fax |
|
| Email |
pranitaingle305@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Rajesh Kubde |
| Designation |
Professor |
| Affiliation |
VSPM DENTAL COLLEGE NAGPUR |
| Address |
VSPM Dental College and Research Center,Digdoh Hills Hingna Nagpur.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9881199669 |
| Fax |
|
| Email |
drkubderajesh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Pranita Ingle |
| Designation |
student |
| Affiliation |
VSPM DENTAL COLLEGE NAGPUR |
| Address |
VSPM Dental College and Research Center,Digdoh Hills Hingna Nagpur.
Nagpur MAHARASHTRA 440019 India |
| Phone |
7499760391 |
| Fax |
|
| Email |
pranitaingle305@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM DENTAL COLLEGE DIGDOH HILLS HINGNA NAGPUR,
COUNTRY- INDIA
Pin Code- 440019 |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Pranita Ingle |
VSPM DENTAL COLLEGE DIGGDOH HILLS HINGNA NAGPUR |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS Nagpur MAHARASHTRA |
7499760391
pranitaingle305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2.5 degree celsius saline |
10 mili litre |
| Intervention |
SALINE VOLUME |
5MILLILITER
Frequency OF INTERVENTION is once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 18 to 60 will be included in the study.
2. Both male and female.
3. Systemically healthy patients (Category: American Society of Anesthesiologists class 1).
4. Single rooted tooth indicated for single visit root canal treatment.
5. Ability to read and comprehend the visual analogue scale (VAS) sheets and informed consent.
6. Having no history of painkillers administrated with 12 hours before procedure.
|
|
| ExclusionCriteria |
| Details |
1. Teeth with crown/root fractures
2. Medically compromised patients
3. Compromised periodontium and open apices
4. Patient taken analgesic
5. Pregnant or lactating women
6. Previously treated/initiated root canal treatment
7. Retreatment cases.
|
|
|
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 |
| 1) To Evaluate the Effect of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment |
48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2) To Compare the Effect of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment
3) To analyse the Effect of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment
|
48 hrs |
|
|
Target Sample Size
|
Total Sample Size="39" Sample Size from India="39"
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)
|
25/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2025 |
| 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 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
|
One
of the most essential parts of endodontic practice is the management of
postoperative pain and discomfort, which patients regularly complain after
receiving endodontic treatment(1). Postoperative pain is unpleasant and is
described as discomfort experienced by patients; it has a high incidence rate
ranging between 3% - 58%, and tends to worsen between the initial 6 - 12 hours
after treatment, peaking at around 40% in 24 hours and then declining to 11% in
one week (2,3). The likely causes of postoperative discomfort may be mechanical,
chemical, and/or microbiological damage to the periradicular tissues (2). This sometimes
causes periapical irritation, also known as flareup.
Cryotherapy,
often known as cold therapy , where the surrounding temperature of tissues is
being lowered to relive pain. It has been widely used in sports injuries and
surgical operations to reduce pain and provide postoperative care (12, 13).
(2)Cryotherapy has been shown to reduce inflammation, oedema, pain, and reduces
the recovery time in short-term orthopedic, abdominal, gynecological, and
hernia procedures. (1) Low temperatures cause vasoconstriction, also it reduces
pain by blocking nerve terminals [11]. (2) Vasoconstriction , decreases the release
of inflammatory enzymes, it slow down the cell metabolism, lowering oxygen
demand and limiting free radical generation in tissues (22).
In
dentistry, cryotherapy has already been adopted by professionals, especially
for postoperative pain control after surgical procedures. . (4)The temperature
of the outer surface of the root can be reduced more than 10 C by using cold
saline (2.5 C) for 5 min and has an anti-inflammatory effect on the
periradicular tissue. (3)The first clinical investigation on the use of
intracanal cryotherapy in pain control was undertaken by Al-Nahlawi et al.,
(10) using cold saline (2- 40 C), and observed considerable pain reduction.
Although
the effectiveness of cryotherapy has been well established in the literature,
there is no standardization of the type or volume of the cryoagent used, mode
of application, or duration to identify an ideal protocol for this treatment.
Therefore, the purpose of this study was to evaluate the effect of dual volume
irrigation as a final irrigant following biomechanical preparation of root
canals on postoperative pain in patients with irreversible pulpitis. |