Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

Dental Pulp Necroses Clinical Trial

Official title:

Comparison Of The Effect of Adding XP Endo Finisher To The Irrigation Protocol Versus Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02952326
• Other study ID #: XP and Protaper next
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2016
• Last updated: November 14, 2016
• Start date: December 2016
• Est. completion date: January 2018

Study information

• Verified date: November 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.

Description:

patients are randomized into 2 groups after meeting the eligibility criteria,

1. Each patient will be given pain scale chart in order to record his /her pain level before any intervention.

2. The tooth is anesthetized, accessed and mechanical instrumentation to be made 3 A) For the experimental group: The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation

B) For the control group :

The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.

4) Obturation is done and postoperative instructions are given to the patient

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

i. Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars

• Asymptomatic.

• Non-vital response of pulp tissue (negative response).

• With or without periapical radiolucency.

Exclusion Criteria:

i. Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively.

v. Patients having bruxism or clenching. vi. Teeth that have :

• Vital pulp tissues.

• Association with swelling

• Acute peri-apical abscess

• Periodontally affected teeth

• No possible restorability

• Previous endodontic treatment.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Necroses
• Dental Pulp Necrosis
• Necrosis

Intervention

Procedure:
• XP Endo Finsher as final step of the irrigation protocol
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation
• Conventional needle irrigation only
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Elnaghy AM, Mandorah A, Elsaka SE. Effectiveness of XP-endo Finisher, EndoActivator, and File agitation on debris and smear layer removal in curved root canals: a comparative study. Odontology. 2016 May 20. [Epub ahead of print] — View Citation

Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain recorded by the patient using a four step pain scale (0-3)		up to 5 days after the treatment	No
Secondary	Post-operative swelling		up to 5 days after the treatment	No
Secondary	Need\ number of Analgesic tablets		up to 5 days after the treatment	No
Secondary	Need for systemic antibiotics		up to 5 days after the treatment	No