Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Post operative pain assessed with numerical rating scale
Study Overview
Brief Summary
Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars.
Detailed Description
Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
After the operator find an eligible participant, a phone call is made to the assistant supervisor to confirm the patient eligibility then to assign the participant to either group according to the generated random sequence.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1- Males or Females.
- •2- Mandibular molar teeth with:
- •Pre-operative sharp pain.
- •Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
- •Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures.
Exclusion Criteria
- •Patients having significant systemic disorders.
- •Patients who are allergic to non-steroidal anti-inflammatory drugs.
- •Patients with two or more adjacent teeth requiring root canal therapy.
- •Teeth that have:
- •Necrotic pulp tissues.
- •Association with swelling or fistulous tract.
- •Acute or chronic peri-apical abscess.
- •Greater than grade I mobility.
- •Pocket depth greater than 5mm.
- •No possible restorability.
- •Previous endodontic treatment.
Outcomes
Primary Outcomes
Post operative pain assessed with numerical rating scale
Time Frame: Up to 72 hours post-operatively
0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively
Secondary Outcomes
- Amount of analgesic intake assessed by counting(Up to 72 hours post-operatively)
- Incidence of placebo intake assessed by questioning(Up to 72 hours post-operatively)
Investigators
Mohammed Essam Othman Ibrahim
Resident at Endodontic department Faculty of Dentistry, Cairo University
Cairo University