Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis

Phase 1

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: Ibuprofen 400 mg; Other: cold saline (cryotherapy); Other: Final irrigation with normal saline

• Registration Number: NCT05341999
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22
• Primary Completion: 2023-04
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen post-operative medication.	Ibuprofen 400 mg	a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment
Final irrigation with cold saline (cryotherapy).	cold saline (cryotherapy)	20ml of 2.5°C cold saline for 5 min
Final irrigation with normal saline, and no post-operative medication	Final irrigation with normal saline	final irrigation will be done using normal saline at room temperature.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	48 hours post-operatively	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.