Post Operative Pain of Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis

NCT02952300 | Unknown

• 1 other identifier: CEBC-CU-2016-10-146
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

the aim in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with symptomatic irreversible pulpits. According to the inclusion criteria the patients enrolled in the study and allocated randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is done at single visit. firstly the patient's medical and dental history is taken .the patient assign on informed consent. and then,anaesthetized and access cavity performed and root canal preparation is done by either two systems and then irrigation and obturation is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator will recall the patient to check the records and follow up the patient.

Conditions

Pulpitis - Irreversible

Keywords

irreversible pulpitis; reciprocation; rotation; single file; wave one; neolix

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  intensity of postoperative pain after treatment by Numerical Rating Scale (0-10)

  up to 48 hours after completion of treatment

Study Arms (2)

neolix

EXPERIMENTAL

single full rotation file (Neolix ® Neolix ,France) the 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 Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal

Procedure: neolix

wave one

ACTIVE COMPARATOR

single reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal

Procedure: wave one

Interventions

neolix PROCEDURE

single rotation file

neolix

wave one PROCEDURE

single reciprocation file

wave one

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in good health(American Society of Anesthesiologists Class II or higher).
• Patients having symptomatic irreversible pulpitis in one of their mandibular premolars.
• Age range is between 20 and 35 years.
• Patients who can understand numerical rating scale (NRS).
• Patients able to sign informed consent.

You may not qualify if:

• Patients with positive percussion test .
• Patients having history of necrosis with or without apical pathosis .
• Patients have sinus tract or fistula extraoral or intraoral.
• Patients having active pain in more than one pre molar.
• Patients who had taken analgesics in the 12 hours preceding the preparation.
• Pregnant or mentally retarded patients.
• Teeth with grade 2 or 3 mobility.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.

  PMID: 17956561 BACKGROUND

• Tanalp J, Kaptan F, Sert S, Kayahan B, Bayirl G. Quantitative evaluation of the amount of apically extruded debris using 3 different rotary instrumentation systems. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):250-7. doi: 10.1016/j.tripleo.2005.03.002. Epub 2005 Oct 14.

  PMID: 16448929 BACKGROUND

• Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.

  PMID: 14606784 BACKGROUND

• Pochapski MT, Santos FA, de Andrade ED, Sydney GB. Effect of pretreatment dexamethasone on postendodontic pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):790-5. doi: 10.1016/j.tripleo.2009.05.014. Epub 2009 Sep 12.

  PMID: 19748294 BACKGROUND

• Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9.

  PMID: 19826598 BACKGROUND

• Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.

  PMID: 21419285 BACKGROUND

Study Officials

• abeer marouzk, professor

  faculty of oral and dental medicine -cairo university

  STUDY CHAIR

• alaa el baz, ass. professor

  faculty of oral and dental medicine -cairo university

  STUDY DIRECTOR

• yasmin hassan yousief, resident

  faculty of oral and dental medicine -cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yasmin hassan yousief, resident

CONTACT

01146326683; dr.yasmien90@yahoo.com

alaa elbaz, ass. professor

CONTACT

01000826286

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at endodontic department faculty of oral and dental medicine CU

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share