| CTRI Number |
CTRI/2024/01/061804 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Evaluating the effect of occlusal reduction and cold saline irrigation on pain following single sitting RCT |
|
Scientific Title of Study
|
Effect of Occlusal Reduction and Intracanal Cryotherapy on postoperative pain in Single visit Endodontics- 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 |
Dr. Nishtha Patel |
| Designation |
Professor and Head of the Department |
| Affiliation |
College of Dental Science and Research centre |
| Address |
College of dental science and research centre, nr. navneet printing press, opposite pleasure club, Bopal, Manipur, Gujarat
Ahmadabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nishtha Patel |
| Designation |
Professor and Head of the Department |
| Affiliation |
College of Dental Science and Research centre |
| Address |
College of dental science and research centre, nr. navneet printing press, opposite pleasure club, Bopal, Manipur, Gujarat
Ahmadabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaily Dalal |
| Designation |
Post graduate Student |
| Affiliation |
College of Dental Science and Research centre |
| Address |
College of dental science and research centre, nr. navneet printing press, opposite pleasure club, Bopal, Manipur, Gujarat
Ahmadabad
GUJARAT
380058
India |
| Phone |
9429667840 |
| Fax |
|
| Email |
shailydalal50@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of dental sciences and research centre, bopal, ahmedabad |
|
|
Primary Sponsor
|
| Name |
Shaily Dalal |
| Address |
College of dental science and research centre, nr. navneet printing press, opposite pleasure club, Bopal, Manipur, Gujarat |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| shaily dalal |
College of Dental Sciences & Research Centre, Manipur |
7, first floor, department of conservative dentistry and endodontics, college of dental science and research centre nr. navneet printing press bopal manipur ahmedabad
Ahmadabad
GUJARAT |
9429667840
shailydalal50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE COLLEGEOFDENTALSCIENCESANDRESEARCHCENTRE |
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 |
occlusal reduction and intracanal cryotherapy |
occlusal reduction and intracanal cryotherapy in single visit endodontics |
| Comparator Agent |
without occlusal reduction and intracanal cryotherapy |
post operative pain with and without occlusal reduction and intracanal cryotherapy in single visit endodontics |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
permanent maxillary and mandibular posterior teeth with presence of opposing teeth along with occlusal contact. |
|
| ExclusionCriteria |
| Details |
deciduous teeth. Teeth without occlusal contact. Non restorable teeth. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative pain reduced after occlusal reduction and intracanal cryotherapy in single visit endodontics |
postoperative pain reduced after occlusal reduction and intracanal cryotherapy in single visit endodontics in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative pain reduced after occlusal reduction and intracanl cryotherapy in single visit endodontics |
postoperative pain reduced after 48 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
main reasons dental patients seek endodontic therapy is pain. Some of the
measures to manage postoperative pain and discomfort following root canal
procedures are: preoperative analgesics, long lasting local anaesthetics,
occlusal reduction and more recently intracanal cryotherapy.
Occlusal
reduction may be used as an emergency relief strategy if painful symptoms
develop following root canal procedure, as it can restrict more pressure from
being applied to the teeth, thereby preventing further mechanical periapical
tissue irritation.
Cryotherapy
is the process of applying cold material to reduce the temperature of the
surrounding tissues. The effectiveness of intracanal cryotherapy, i.e using of
cold saline as a final irrigant to relieve post-endodontic pain has been
examined by a number of endodontic researchers.
The
aim of this study is to determine whether occlusal surface and intracanal
cryotherapy would affect postendodontic pain following single-visit root canal
treatment. |