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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02952326
• Collaborator: (none)
• Enrollment: 34
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Pulp Necroses	Procedure: XP Endo Finsher as final step of the irrigation protocol; Procedure: Conventional needle irrigation only	N/A

Detailed 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.

1. Obturation is done and postoperative instructions are given to the patient

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Nov 1, 2017
• Anticipated Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XP Endo Finisher	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
Active Comparator: Conventional needle irrigation	Procedure: Conventional needle irrigation only; The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.

Outcome Measures

Primary Outcome Measures

1. Post-operative pain recorded by the patient using a four step pain scale (0-3) [up to 5 days after the treatment]

Secondary Outcome Measures

1. Post-operative swelling [up to 5 days after the treatment]

2. Need\ number of Analgesic tablets [up to 5 days after the treatment]

3. Need for systemic antibiotics [up to 5 days after the treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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:

1. 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.

2. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. 2017 Apr;105(2):178-183. doi: 10.1007/s10266-016-0251-8. Epub 2016 May 20.
• Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. Review.

• Responsible Party: Ghada Ihab Mohamed, Resident at Endodontic department, faculty of oral and dental medicine, Cairo University
• ClinicalTrials.gov Identifier: NCT02952326
• Other Study ID Numbers: XP and Protaper next
• First Posted: Nov 2, 2016
• Last Update Posted: Nov 15, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dental Pulp Necrosis; Necrosis

Study Results

No Results Posted as of Nov 15, 2016