NCT05341999

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
OTHER	cold saline (cryotherapy)	using 20ml of 2.5°C cold saline for 5 min
DRUG	Ibuprofen 400 mg	patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
OTHER	Final irrigation with normal saline	final irrigation will be done using normal saline at room temperature.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2022-04-22
• Last updated: 2022-04-22