Clinical trial NCT05341999: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Full medical and dental history will be obtained from all the patients .
2. Thorough clinical and radiographic examination for the tooth to be treated will be done.
3. The tooth will be anaesthetized and Access cavity will be performed.
4. The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument.
5. Canals will be dried using sterile paper points.
6. 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.
7. In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
8. In the control group, final irrigation will be done using normal saline at room temperature.
9. 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.
10. The access cavity will then be closed with temporary filling.
11. 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.

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.

Primary outcomes:
measure: Post-operative pain
timeFrame: 6 hours post-operatively
measure: Post-operative pain
timeFrame: 24 hours post-operatively
measure: Post-operative pain
timeFrame: 48 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: