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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05341999
Collaborator
(none)
36
3
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cold saline (cryotherapy)
  • Drug: Ibuprofen 400 mg
  • Other: Final irrigation with normal saline
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Post-operative pain [6 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.

  2. Post-operative pain [24 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yousef Hassan Mohammed Abuhelal, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05341999
Other Study ID Numbers:
  • ENDO3/3/5
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022