Clinical trial NCT03692039: Comparison Between M-Pro and ProTaper Next
Official title: Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post operative pain assessed with numerical rating scale
timeFrame: Up to 72 hours post-operatively
Secondary outcomes:
measure: Incidence of placebo intake assessed by questioning
timeFrame: Up to 72 hours post-operatively
measure: Amount of analgesic intake assessed by counting
timeFrame: Up to 72 hours post-operatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
Study officials:
References:
citation: Kocak MM, Cicek E, Kocak S, Saglam BC, Furuncuoglu F. Comparison of ProTaper Next and HyFlex instruments on apical debris extrusion in curved canals. Int Endod J. 2016 Oct;49(10):996-1000. doi: 10.1111/iej.12552. Epub 2015 Oct 12.
citation: Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.