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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Other: cold saline (cryotherapy); Drug: Ibuprofen 400 mg; Other: Final irrigation with normal saline

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yousef H Abuhelal, Master; Phone Number: +201033054851; Email: yousefhassan@dentistry.cu.edu.eg
• Study Contact Backup: Name: Radwa S Emara, PHD; Phone Number: +201272141312; Email: radwa.emara@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Final irrigation with cold saline (cryotherapy).; 20ml of 2.5°C cold saline for 5 min	Other: cold saline (cryotherapy); using 20ml of 2.5°C cold saline for 5 min
EXPERIMENTAL: Ibuprofen post-operative medication.; a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment	Drug: Ibuprofen 400 mg; patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
ACTIVE_COMPARATOR: Final irrigation with normal saline, and no post-operative medication; final irrigation will be done using normal saline at room temperature.	Other: Final irrigation with normal saline; final irrigation will be done using normal saline at room temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: ENDO3/3/5

Drug and device information, study documents

• 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