Comparison Between M-Pro and ProTaper Next

Symptomatic Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692039
• Other study ID #: CEBD-CU-2018-09-33
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Procedure:
• M-pro files in rotating motion
An endodontic file that has controlled memory properties
• ProTaper Next files in rotating motion
An endodontic file that has an off center mass of rotation

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Koçak MM, Çiçek E, Koçak 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. — View Citation

Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain assessed with numerical rating scale	0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively	Up to 72 hours post-operatively
Secondary	Incidence of placebo intake assessed by questioning	Amount of placebo intake up to 72 hours post-operatively	Up to 72 hours post-operatively
Secondary	Amount of analgesic intake assessed by counting	Number of analgesic tablets up to 72 hours post-operatively	Up to 72 hours post-operatively