Symptomatic Irreversible Pulpitis
Conditions
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.
Interventions
PROCEDUREM-pro files in rotating motion
An endodontic file that has controlled memory properties
PROCEDUREProTaper Next files in rotating motion
An endodontic file that has an off center mass of rotation
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A & B and randomly distributed. The table is kept with the assistant supervisor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain assessed with numerical rating scale | Up to 72 hours post-operatively | 0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of placebo intake assessed by questioning | Up to 72 hours post-operatively | Amount of placebo intake up to 72 hours post-operatively |
| Amount of analgesic intake assessed by counting | Up to 72 hours post-operatively | Number of analgesic tablets up to 72 hours post-operatively |
Countries
Egypt
Outcome results
None listed