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

Symptomatic Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05341999
• Other study ID #: ENDO3/3/5
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2022
• Est. completion date: May 2023

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: Yousef H Abuhelal, Master
• Phone: +201033054851
• Email: yousefhassan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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