Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File)

NCT03059290 | Unknown

• 1 other identifier: CEBC-CE-2017-01-15
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

this prospective in vivo randomized clinical is to evaluate the post operative pain (incidence ,degree and duration) with multiple full rotation file (protaper next ®) and single full rotation file (Neolix®) in treating maxillary and mandibular anterior and premolar with chronic pulpitis .Together with our aim from this trial ; we are trying to provide an evidence for the dentists in order to provide the best quality service with the least expenses and thus gaining the patients' trust and saving time, money and effort.

Conditions

Necrotic Pulp

Keywords

post operative pain; Post operative flare ups; Post endodontic pain; Post endodontic flare ups; Necrotic teeth; Non vital teeth; Neolix file; Single rotating file; Protaper next file; Multiple rotating file; Single visit

Outcome Measures

Primary Outcomes (4)

• the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

  6 hours

• the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

  12 hours

• the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

  24 hours

• the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

  48 hours

Study Arms (1)

protaper next file

ACTIVE COMPARATOR

the PROTAPER NEXT™ X1 (017/04) file, in one or more passes until the working length is reached. Use PROTAPER NEXT X2 (025/06), exactly as described for PROTAPER NEXT X1 file, until the working length is passively reached. Gauge the foramen with a size 025 hand file and, if this file binds at length, the canal is shaped and ready for disinfection. If the size 025 hand file is loose at length, then continue shaping with the PROTAPER NEXT X3 (30/07) and, when necessary, the PROTAPER NEXT X4 (040/06) or PROTAPER NEXT X5 (050/06), gauging after each instrument with the 030, 040 or 050 hand files, respectively. During canal shaping, irrigate, recapitulate with a small-sized hand file after each sequential PROTAPER NEXT instrument, then re-irrigate. in an endodontic motor according to the manufacturer instructions (X-Smart, Dentsply Maillefer, USA.), with torque 2.0 N.cm and speed 300 rpm.

Device: neolix file

Interventions

neolix file DEVICE

first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani ,Japan ) is loose or pass easily in the canal , but in case of K-file size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with (X-Smart, Dentsply Maillefer, USA.), with speed 300-500 rpm and torque 1.5 N.cm

protaper next file

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically free patients.
• Patient's age (20-65) years old.
• Upper \&lower anterior and premolar teeth diagnosed clinically as necrotic teeth.
• Positive patient's acceptance for participation in the study.
• Sex includes both male and female.
• Patients who can understand Numerical Rating Scale.
• Patients able to sign informed consent.

You may not qualify if:

• Pregnancy or lactation.
• Medically compromised patients.
• Patient with multiple teeth that required treatment to eliminate the possibility of pain referral.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• nehal nabil, assistant professor

  faculty of oral and dental medicine - cairo university

  STUDY CHAIR

Central Study Contacts

karim ahmed nahas, master degree candidate

CONTACT

+201006300519; karimnahas34@gmail.com

siza yacoub el zakhary, professor

CONTACT

+201006621083; siza.yacoub@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master candidate at endodontic department faculty of oral and dental medicine CU

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02