Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
cold saline (cryotherapy)
Ibuprofen 400 mg
Final irrigation with normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria: - Patients above 18 years old and to 60.
- 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.
Exclusion Criteria:
- 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.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Final irrigation with cold saline (cryotherapy).
Ibuprofen post-operative medication.
Final irrigation with normal saline, and no post-operative medication
Arm Description
20ml of 2.5°C cold saline for 5 min
a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment
final irrigation will be done using normal saline at room temperature.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341999
Brief Title
Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
PICO/
Population: Molar teeth with symptomatic irreversible pulpitis. Intervention I: Final irrigation with cold saline (cryotherapy). Intervention II: Ibuprofen post-operative medication.
Control: Final irrigation with normal saline, and no post-operative medication. Outcome: Post- operative pain.
Sequence of Procedural steps:
Full medical and dental history will be obtained from all the patients .
Thorough clinical and radiographic examination for the tooth to be treated will be done.
The tooth will be anaesthetized and Access cavity will be performed.
The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument.
Canals will be dried using sterile paper points.
In the intervention group 1, cryotherapy irrigation will be done using 20ml of 2.5°C cold saline for 5 min, the cold saline will be stored in an icebox with a thermometer calibrated at 2.5°C.
In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
In the control group, final irrigation will be done using normal saline at room temperature.
Canals will be dried using sterile paper points, and then filled with gutta percha cones corresponding to the same size of the final shaping file and sealed with sealer.
The access cavity will then be closed with temporary filling.
Post-operative instructions will be given to all patients. • The patient will be asked to rate their pain level according to the given instructions and telecommunication will be scheduled after 3 days to collect the VAS scores and assess the outcome of the treatment. The patients who will be suffered from severe pain, analgesic will be prescribed.
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
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Final irrigation with cold saline (cryotherapy).
Arm Type
Experimental
Arm Description
20ml of 2.5°C cold saline for 5 min
Arm Title
Ibuprofen post-operative medication.
Arm Type
Experimental
Arm Description
a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment
Arm Title
Final irrigation with normal saline, and no post-operative medication
Arm Type
Active Comparator
Arm Description
final irrigation will be done using normal saline at room temperature.
Intervention Type
Other
Intervention Name(s)
cold saline (cryotherapy)
Intervention Description
using 20ml of 2.5°C cold saline for 5 min
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
Intervention Type
Other
Intervention Name(s)
Final irrigation with normal saline
Intervention Description
final irrigation will be done using normal saline at room temperature.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
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.
Time Frame
6 hours post-operatively
Title
Post-operative pain
Description
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.
Time Frame
24 hours post-operatively
Title
Post-operative pain
Description
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.
Time Frame
48 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patients above 18 years old and to 60.
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.
Exclusion Criteria:
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.
TMJ problems, bruxism, clenching or traumatic occlusion.
Inability to perceive the given instructions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousef H Abuhelal, Master
Phone
+201033054851
Email
yousefhassan@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa S Emara, PHD
Phone
+201272141312
Email
radwa.emara@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
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