Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next
Primary Purpose
Tooth, Nonvital
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single visits
two visits
Sponsored by
About this trial
This is an interventional treatment trial for Tooth, Nonvital focused on measuring necrotic teeth, single visit, multiple visits, protaper next
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single visit endodontic treatment.
Two visits endodontic treatment
Arm Description
•single visit endodontic Treatment of necrotic teeth using Protaper next.
•Two visits endodontic Treatment of necrotic teeth using Protaper next.
Outcomes
Primary Outcome Measures
Change of post operative pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02984488
Brief Title
Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next
Official Title
Post-Obturation Pain Following One-visit Versus Two-visit Root Canal Treatment of Necrotic Anterior and Premolar Teeth Using Protaper Next
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Nonvital
Keywords
necrotic teeth, single visit, multiple visits, protaper next
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single visit endodontic treatment.
Arm Type
Experimental
Arm Description
•single visit endodontic Treatment of necrotic teeth using Protaper next.
Arm Title
Two visits endodontic treatment
Arm Type
Active Comparator
Arm Description
•Two visits endodontic Treatment of necrotic teeth using Protaper next.
Intervention Type
Procedure
Intervention Name(s)
single visits
Intervention Description
Endodontic treatment is done and completed in a single visit using protaper next rotary system.
Intervention Type
Procedure
Intervention Name(s)
two visits
Intervention Description
Endodontic treatment is done and completed in two visits using protaper next rotary system.
Primary Outcome Measure Information:
Title
Change of post operative pain.
Time Frame
After 6-12-24-48 hours from the obturation step of the endodontic treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hebatallah M nada, student
Phone
o1112393619
Email
dr_heba_nada@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer sabi, lecturer
Phone
01001192266
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed M Abd El aziz, professor
Organizational Affiliation
Department of endodontics - Faculty of Oral and Dental medicine - CU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
hebatallah M nada, student
Organizational Affiliation
Department of endodontics - Faculty of Oral and Dental medicine - CU
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24876699
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. Epub 2014 Apr 26.
Results Reference
background
PubMed Identifier
12075212
Citation
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.
Results Reference
background
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Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next
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