Back to resultsEffect of Cryotherapy on Postoperative Pain
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryotherapy
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria:
- Age between 20-40 years old.
- Systemically healthy patient (ASA I or II).
- mandibular first molar teeth with:
- Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
- Ability for isolation with rubberdam.
- Restorable teeth
- Ability to fill the root canals in single visit treatment.
Exclusion Criteria:
- Teeth without good apical constriction, such as wide or open apex
- Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Teeth that have :
Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
cryotherapy
normal saline
Arm Description
2.5c cold saline as a final flush after chemicomechanical debridement
room temperature saline is used as a final flush after chemicomechanical preparation
Outcomes
Primary Outcome Measures
postoperative pain assessed by NRS
Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain"
1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"
Secondary Outcome Measures
amount of analgesics assessed by counting
number of analgesics tablets up to 48 hrs postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03716635
Brief Title
Effect of Cryotherapy on Postoperative Pain
Official Title
Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis
Detailed Description
the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A random sequence will be generated by computer software, (http://www.random.org/).
The table will be kept with the assistant supervisor.
Masking
Participant
Masking Description
After determining the eligibility of the patient, the assistant supervisor will be contacted to assign the participant to either the intervention (cryotherapy) or the control (normal saline) groups according to the random sequence generated.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryotherapy
Arm Type
Experimental
Arm Description
2.5c cold saline as a final flush after chemicomechanical debridement
Arm Title
normal saline
Arm Type
Other
Arm Description
room temperature saline is used as a final flush after chemicomechanical preparation
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
2.5c cold saline is used as a final flush after chemomechanical preparation
Intervention Type
Procedure
Intervention Name(s)
normal saline
Intervention Description
a room temperature saline is used as a final flush after mechanical preparation
Primary Outcome Measure Information:
Title
postoperative pain assessed by NRS
Description
Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain"
1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"
Time Frame
up to 48 hrs postoperative pain
Secondary Outcome Measure Information:
Title
amount of analgesics assessed by counting
Description
number of analgesics tablets up to 48 hrs postoperatively
Time Frame
up to 48 hrs postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 20-40 years old.
Systemically healthy patient (ASA I or II).
mandibular first molar teeth with:
Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
Ability for isolation with rubberdam.
Restorable teeth
Ability to fill the root canals in single visit treatment.
Exclusion Criteria:
Teeth without good apical constriction, such as wide or open apex
Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.
Patients having significant systemic disorder (ASA III or IV).
Teeth that have :
Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
magy E elaskary
Phone
01001467262
Email
magiessam@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29398090
Citation
Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
Results Reference
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Effect of Cryotherapy on Postoperative Pain
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