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

Tooth, Nonvital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02984488
• Other study ID #: single_two visits
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2016
• Last updated: December 6, 2016
• Start date: December 2016
• Est. completion date: February 2018

Study information

• Verified date: November 2016
• Source: Cairo University
• Contact: hebatallah M nada, student
• Phone: o1112393619
• Email: dr_heba_nada[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Necrosis
• Tooth, Nonvital

Intervention

Procedure:
• single visits
Endodontic treatment is done and completed in a single visit using protaper next rotary system.
• two visits
Endodontic treatment is done and completed in two visits using protaper next rotary system.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of post operative pain.		After 6-12-24-48 hours from the obturation step of the endodontic treatment.	No