Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
Evaluation of the Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis . a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedApril 22, 2022
April 1, 2022
1 year
April 14, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Post-operative pain
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
6 hours post-operatively
Post-operative pain
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
24 hours post-operatively
Post-operative pain
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
48 hours post-operatively
Study Arms (3)
Final irrigation with cold saline (cryotherapy).
EXPERIMENTAL20ml of 2.5°C cold saline for 5 min
Ibuprofen post-operative medication.
EXPERIMENTALa single dose of Ibuprofen 400 mg immediately after completion of root canal treatment
Final irrigation with normal saline, and no post-operative medication
ACTIVE COMPARATORfinal irrigation will be done using normal saline at room temperature.
Interventions
using 20ml of 2.5°C cold saline for 5 min
patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
final irrigation will be done using normal saline at room temperature.
Eligibility Criteria
You may qualify if:
- Male or female.
- Patients seeking root canal treatment.
- Molar teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
- Systematically healthy patient (ASA I).
- Patient who can understand VAS and sign informed consent.
You may not qualify if:
- Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption.
- Internal root resorption.
- Vertical root fracture.
- Periapical lesion.
- Pregnancy.
- Use of ibuprofen in the last 12 hour.
- Bleeding disorder.
- Long term corticosteroid use. 10
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 22, 2022
Study Start
April 1, 2022
Primary Completion
April 1, 2023
Study Completion
May 1, 2023
Last Updated
April 22, 2022
Record last verified: 2022-04