| CTRI Number |
CTRI/2021/12/038351 [Registered on: 01/12/2021] Trial Registered Prospectively |
| Last Modified On: |
24/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of cryotherapy and laser treatment in management of pain after root canal treatment |
|
Scientific Title of Study
|
Effect of intracanal cryotherapy and intracanal laser irradiation in management of post-endodontic pain- Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyankaa Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of Dental Sciences, SOA Deemed to be University |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number-7, Institute of Dental Sciences, SOA Deemed to be University,Near SUM Hospital, K-8 Kalinga Nagar, Ghatikia, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
08763987053 |
| Fax |
|
| Email |
priyankaa.das053@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debkant Jena |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences, SOA Deemed to be University |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number-7,Institute of Dental Sciences, SOA Deemed to be University, Near SUM Hospital, K-8 Kalinga Nagar,Ghatikia, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8895547956 |
| Fax |
|
| Email |
debkantjena@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyankaa Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of Dental Sciences, SOA Deemed to be University |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number-7,Institute of Dental Sciences, SOA Deemed to be University, Near SUM Hospital, K-8 Kalinga Nagar, Ghatikia, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
08763987053 |
| Fax |
|
| Email |
priyankaa.das053@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Room Number-7,Institute of Dental Sciences, Near SUM Hospital, K-8 Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha, PIN-751003 |
|
|
Primary Sponsor
|
| Name |
Siksha O Anusandhan Deemed to be University |
| Address |
Department of Conservative Dentistry & Endodontics,Room Number-7, Institute of Dental Sciences,Near SUM Hospital, K-8 Kalinga Nagar, Ghatikia,Bhubaneswar,Odisha, Pin-751003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Priyankaa Das |
Institute of Dental Sciences |
Department of Conservative Dentistry and Endodontcs, Room Number-7, Institute of Dental Sciences, SOA Deemed to be University, Near SUM Hospital, K-8 Kalinga Nagar,Ghatikia, Bhubaneswar
Khordha
ORISSA |
08763987053
priyankaa.das053@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS and SUM Hospitals, Bhubaneswar |
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 |
| Comparator Agent |
Control group |
Normal saline will be the final irrigant |
| Intervention |
Intracanal cryotherapy |
4 degrees cold saline solution as final irrigant administered for 5 minutes in intracanal cryotherapy group |
| Intervention |
Intracanal laser irradiation |
Intracanal laser irradiation in canals with diode laser |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having a maxillary or mandibular molar tooth with vital pulp and required to display symptomatic apical periodontitis. |
|
| ExclusionCriteria |
| Details |
1.Absence of bleeding in the pulp chamber on access cavity preparation.
2.Presence of any systemic disease or allergic conditions.
3.Previous root canal treatment
4.Sinus tracts/local gum swelling around the affected tooth
5.Severe periodontal disease
6.Presence of periodontal pockets >3mm in the affected tooth
7.Presence of a periapical radiolucency
8.Excessively curved roots
9.Excessively long or short root length
10.Problems in determining working length
11.Broken files
12.Overinstrumentation, and overfilling/ incomplete filling
|
|
|
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 |
| Reduction of post operative pain after single sitting root canal treatment |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of the intervention groups |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/12/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [priyankaa.das053@gmail.com].
- For how long will this data be available start date provided 12-01-2022 and end date provided 25-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Randomized clinical trial will be performed in patients diagnosed with symptomatic apical periodontitis. Preoperative pain scores will be recorded using Visual Analog Scale(VAS) before initiating root canal treatment by an evaluator who is blinded to randomization. Standard Inferior Alveolar Nerve Block and Buccal infiltration using 2% lidocaine with 1:2,00,000 epinephrine will be administered in mandibular and maxillary molars, respectively. The participants will be randomly divided into groups(n=20 in each group). Group A- normal saline, Group B- intracanal cryotherapy and Group C- intracanal laser irradiation. Single sitting root canal treatment will be carried out. Access opening will be done with an Endo-access bur and de-roofing of the pulp chamber with Endo-Z bur, cleaning and shaping will be done in all the groups. In Group A, the final irrigant will be normal saline, in Group B, 4 degrees cold saline will be the final irrigant and in Group C, low level laser irradiation will be done with diode laser. In all the groups, combination of single cone and warm vertical obturation will be carried out followed by composite access restoration. VAS scores will be recorded for during and after the root canal treatment and verbal analog scale scores will be recorded uptill 7 days. |