Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next

Post-Obturation Pain Following One-visit Versus Two-visit Root Canal Treatment of Necrotic Anterior and Premolar Teeth Using Protaper Next

To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument.

Study Overview

• Status: Unknown
• Conditions: Tooth, Nonvital
• Intervention / Treatment: Procedure: single visits; Procedure: two visits

Detailed Description

The key to endodontic success was described as the debridement and neutralization of any tissue, bacteria, or inflammatory products within the root canal system.

Endodontic treatment used to take multiple visits to complete, with one of the main reasons for this being that it required a considerable amount of time to complete the treatment.

The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of diathermy for pulpal disinfection and hydrogen peroxide for irrigation.

The use of contemporary endodontic techniques and equipment, such as use of rubber dam, magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and so forth, not only increases the success rate of endodontic treatment but also, shortens the time needed for the treatment. Endodontic treatment may therefore be completed in a single visit.

It is generally agreed upon that the prepared canals can never be sterile before obturation, no matter how potent the antibacterial irrigants or intracanal medications are. There are currently two measures to reduce bacterial persistence and reinfection in the canals. We can either dress the canals with antibacterial agents in multiple visits or immediately obturate the canals, to reduce the space for bacterial colonization, in a single-visit approach. Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy towards Enterococcus faecalis is questionable.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Medically free patients.
• Patient's age above 18 years old.
• Teeth diagnosed clinically with necrosis.
• Positive patient's acceptance for participation in the study.
• Sex includes both male and female.
• Patients who can understand visual analogue scale.
• Patients able to sign informed consent.

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single visit endodontic treatment.; •single visit endodontic Treatment of necrotic teeth using Protaper next.	Procedure: single visits; Endodontic treatment is done and completed in a single visit using protaper next rotary system.
Active Comparator: Two visits endodontic treatment; •Two visits endodontic Treatment of necrotic teeth using Protaper next.	Procedure: two visits; Endodontic treatment is done and completed in two visits using protaper next rotary system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of post operative pain.	After 6-12-24-48 hours from the obturation step of the endodontic treatment.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Saeed M Abd El aziz, professor, Department of endodontics - Faculty of Oral and Dental medicine - CU; Principal Investigator: hebatallah M nada, student, Department of endodontics - Faculty of Oral and Dental medicine - CU

Publications and helpful links

General Publications

• DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.
• Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: single visit; necrotic teeth; multiple visits; protaper next
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Tooth, Nonvital
• Other Study ID Numbers: single_two visits

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO