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Status unknownNCT02984488Updated Dec 7, 2016

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

An interventional study of single visits and two visits in Tooth, Nonvital, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth, Nonvital

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Keywords

  • necrotic teeth
  • single visit
  • multiple visits
  • protaper next
03

In context

Tooth, Nonvital

118 studies on the registry are indexed under Tooth, Nonvital; 18 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 108 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    single visit endodontic treatment.

    •single visit endodontic Treatment of necrotic teeth using Protaper next.

    Procedure: single visits

  • Active comparator
    Two visits endodontic treatment

    •Two visits endodontic Treatment of necrotic teeth using Protaper next.

    Procedure: two visits

Interventions

  • Proceduresingle visits

    Endodontic treatment is done and completed in a single visit using protaper next rotary system.

  • Proceduretwo visits

    Endodontic treatment is done and completed in two visits using protaper next rotary system.

06

What researchers measure

Primary outcomes

  1. Change of post operative pain.

    Time frame: After 6-12-24-48 hours from the obturation step of the endodontic treatment.

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24876699 ↗
  • 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. PubMed 12075212 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02984488
Lead sponsor
Cairo University
Responsible party
Hebatallah Mostafa Mahmoud Ahmed Nada (principal investigator, Cairo University) — Principal investigator
First posted
Dec 7, 2016
Start date
Dec 2016
Primary completion
Dec 2017 (estimated)
Completion
Feb 2018 (estimated)
Last update
Dec 7, 2016

Study contacts

hebatallah M nada, student
Contact
dr_heba_nada@hotmail.com
o1112393619
Abeer sabi, lecturer
Contact
01001192266
Saeed M Abd El aziz, professor
study chair · Department of endodontics - Faculty of Oral and Dental medicine - CU
hebatallah M nada, student
principal investigator · Department of endodontics - Faculty of Oral and Dental medicine - CU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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