- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716635
Effect of Cryotherapy on Postoperative Pain
Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: magy E elaskary
- Phone Number: 01001467262
- Email: magiessam@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: cryotherapy
2.5c cold saline as a final flush after chemicomechanical debridement
|
2.5c cold saline is used as a final flush after chemomechanical preparation
|
OTHER: normal saline
room temperature saline is used as a final flush after chemicomechanical preparation
|
a room temperature saline is used as a final flush after mechanical preparation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain assessed by NRS
Time Frame: up to 48 hrs postoperative pain
|
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" |
up to 48 hrs postoperative pain
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of analgesics assessed by counting
Time Frame: up to 48 hrs postoperatively
|
number of analgesics tablets up to 48 hrs postoperatively
|
up to 48 hrs postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2018-10-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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