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

NCT ID: NCT05341999

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-05-31

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.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Final irrigation with cold saline (cryotherapy).

20ml of 2.5°C cold saline for 5 min

Group Type: EXPERIMENTAL

cold saline (cryotherapy)

Intervention Type: OTHER

using 20ml of 2.5°C cold saline for 5 min

Ibuprofen post-operative medication.

a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment

Group Type: EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type: DRUG

patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.

Final irrigation with normal saline, and no post-operative medication

final irrigation will be done using normal saline at room temperature.

Group Type: ACTIVE_COMPARATOR

Final irrigation with normal saline

Intervention Type: OTHER

final irrigation will be done using normal saline at room temperature.

Interventions

cold saline (cryotherapy)

using 20ml of 2.5°C cold saline for 5 min

Intervention Type: OTHER

Ibuprofen 400 mg

patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.

Intervention Type: DRUG

Final irrigation with normal saline

final irrigation will be done using normal saline at room temperature.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yousef Hassan Mohammed Abuhelal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yousef H Abuhelal, Master

Role: CONTACT

yousefhassan@dentistry.cu.edu.eg

+201033054851

Radwa S Emara, PHD

Role: CONTACT

radwa.emara@dentistry.cu.edu.eg

+201272141312

Other Identifiers

ENDO3/3/5

Identifier Type: -

Identifier Source: org_study_id