| CTRI Number |
CTRI/2021/04/033256 [Registered on: 29/04/2021] Trial Registered Prospectively |
| Last Modified On: |
16/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF THE EFFECTIVENESS OF VARIOUS COOLING THERAPY ON PAIN AFTER ROOT CANAL TREATMENT IN PATIENTS PRESENTING WITH TOOTHACHE DUE TO ROOT CANAL INFECTION. |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of intracanal and intraoral cryotherapy on postendodontic pain in patients 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 Ajeesh K |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College , Kozhikode |
| Address |
Government Medical College Road
Kozhikode
KERALA
673008
India |
| Phone |
09745212182 |
| Fax |
|
| Email |
ajsh93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasree S |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College , Kozhikode |
| Address |
Government Medical College Road
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayasree S |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College , Kozhikode |
| Address |
Government Medical College Road
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT DENTAL COLLEGE KOZHIKODE |
|
|
Primary Sponsor
|
| Name |
DR AJEESH K |
| Address |
JUNIOR RESIDENT
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
GOVERNMENT DENTAL COLLEGE
KOZHIKODE
KERALA 673008 |
| 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 |
| DR AJEESH K |
ROOM NO. 63 DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS |
GOVERNMENT DENTAL COLLEGE
Kozhikode
KERALA |
09745212182
ajsh93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT DENTAL COLLEGE KOZHIKODE |
Approved |
|
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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 |
| Comparator Agent |
Control group |
After completion of the sodium hypochlorite and EDTA irrigation, the
root canals will be given a final irrigation with 20 mL room temperature saline solution for 5
minutes using side vented needle. The root canal filling and restoration procedures will be then
performed. Time will be recorded. |
| Intervention |
Intracanal Cryotherapy Group |
After completion of the sodium hypochlorite and EDTA irrigation, the
root canals will be given a final irrigation with 20 mL cold (2 to 4°C) saline solution for 5
minutes using side vented needle. |
| Intervention |
Intraoral cryotherapy group |
The root canals in this group will be given a final irrigation with 20
mL room temperature saline solution for 5 minutes using side vented needle. The root canal
filling and restoration procedures will be then performed. Next, small ice packs (wrapped in
sterile gauze) will be placed intraorally in the mouth on the vestibular surface of the treated
tooth. Participants will be instructed to keep the ice pack in the mouth for 10 minutes and to
remove the intraoral ice pack intermittently if they felt extreme cold or a burning sensation and
time will be recorded.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Uniradicular teeth that are diagnosed with symptomatic apical periodontitis.
2.Healthy patients without systemic disease.
3.Patients with pre-operative pain score ranging from moderate to severe (3–10) on a visual analog scale (VAS) (0–10)
|
|
| ExclusionCriteria |
| Details |
1.Pregnant patients
2.Patients with severe periodontal diseases
3.Teeth with incomplete apex formation, excessively curved roots and calcified canals
4.Periapical abscess and sinus opening
5.Patients on analgesics for the last 8 hours or on antibiotic therapy.
6.Previous root canal treatment.
7.Cases with broken files, over-instrumentation.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain measurement using Visual Analog Scale after Root Canal Treatment |
6 and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for analgesic usage |
6 and 24 hours postoperatively |
| Pain changes among gender and age groups |
6 and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2021 |
| Date of Study Completion (India) |
20/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 a randomized, double-blinded, parallel group clinical trial to assess and compare the effectiveness of intracanal and intraoral cryotherapy on postoperative pain in teeth with symptomatic apical periodontitis. The primary outcome measure will be the measurement of postoperative pain in intracanal, intraoral and control group, 6 and 24 hours postoperatively using Visual Analog Scale. The secondary objectives are the measurement of the need for analgesics and postoperative pain changes among gender and age groups. |