Effect of Two Intracanal Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis in Mandibular Molars: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 45
- Primary Endpoint
- Incidence and severity of postoperative pain
Study Overview
Brief Summary
The aim of this study is to evaluate the effect of intracanal cryotreated (2-3°C) 2.5% sodium hypochlorite and Saline used throughout the procedure, compared with a room-temperature irrigation protocol with a final cryotreated saline flush or an entirely room temperature irrigation protocol, on postoperative pain in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis in mandibular molars.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 20-40 years old.
- •Systemically healthy patients (ASA I or II).
- •Mature Mandibular molar teeth with :
- •Preoperative sharp pain and symptomatic apical periodontitis marked on NRS scale by reading not less than
- •Absence or slight widening in the periodontal ligament (PDL).
- •Vital response of pulp tissue to cold pulp tester and (ethyl chloride spray).
- •Positive response to percussion test.
- •Restorable teeth.
- •Ability to complete the endodontic treatment in a single visit.
- •Positive patient acceptance for participation in the trial. -----------------------------------------------------------------
Exclusion Criteria
- •Medically compromised patients (ASA III or IV)
- •Patients who used NSAIDs in the 24 hours before treatment.
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •Pregnant women.
- •Patients reporting bruxism or clenching.
- •Teeth associated with :
- •Acute periapical abscess and/or swelling.
- •Greater than grade I mobility or pocket depth greater than 5mm.
- •Non-restorable teeth.
- •Immature Apex.
- •Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
Outcomes
Primary Outcomes
Incidence and severity of postoperative pain
Time Frame: From enrollment to the end of treatment at 3 days
Using an 11-point Numeric Rating Scale (NRS) where the endpoints are the extremes of no pain and worst pain. Pain intensity was assigned into one of four pain categories: none (0); Mild (1-3); Moderate (4-6) and severe (7-10). Postoperative pain levels will be documented by the patients at 6, 12, 24, 48 and 72 hours postoperatively
Secondary Outcomes
- Incidence and Number of analgesic intake(From enrollment to the end of treatment at 3 days)
Investigators
Ahmed Mahmoud Mohamed
Dentist
Cairo University