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Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems

Primary Purpose

Asymptomatic Molar Teeth With Periapical Lesions

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Protaper Universal instruments
Reciproc Blue instruments
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Molar Teeth With Periapical Lesions focused on measuring one-visit root canal treatment,, engine-driven instruments,, asymptomatic molar teeth wtih periapical lesions

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients without systemic diseases
  • Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
  • Patients who had no spontaneous pre-treatment pain
  • Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
  • Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.

Exclusion Criteria:

  • Patients who had severe periodontal disease
  • The teeth with previous endodontic treatment
  • The teeth with root canal calcification, root resorption
  • The teeth that could not be isolated with rubber dam or were not suitable for further restoration

Sites / Locations

  • Gözde Kandemir Demirci

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rotary Engine-driven Instruments

Reciprocal Engine-driven Instruments

Arm Description

The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots.

The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots.

Outcomes

Primary Outcome Measures

The incidence of postoperative pain
Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2020
Last Updated
June 30, 2020
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04454814
Brief Title
Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems
Official Title
Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.
Detailed Description
The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value < .05 or less was considered significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Molar Teeth With Periapical Lesions
Keywords
one-visit root canal treatment,, engine-driven instruments,, asymptomatic molar teeth wtih periapical lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotary Engine-driven Instruments
Arm Type
Active Comparator
Arm Description
The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots.
Arm Title
Reciprocal Engine-driven Instruments
Arm Type
Active Comparator
Arm Description
The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots.
Intervention Type
Other
Intervention Name(s)
Protaper Universal instruments
Intervention Description
Root canal treatment using Protaper Universal instruments
Intervention Type
Other
Intervention Name(s)
Reciproc Blue instruments
Intervention Description
Root canal treatment using Reciproc Blue instruments
Primary Outcome Measure Information:
Title
The incidence of postoperative pain
Description
Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.
Time Frame
6-hour to 7-day

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: Patients without systemic diseases Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion Patients who had no spontaneous pre-treatment pain Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit, Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs. Exclusion Criteria: Patients who had severe periodontal disease The teeth with previous endodontic treatment The teeth with root canal calcification, root resorption The teeth that could not be isolated with rubber dam or were not suitable for further restoration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gözde Kandemir Demirci
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seniha Miçooğulları Kurt
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Burcu Serefoglu
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet E Kaval
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet K Çalışkan
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Study Chair
Facility Information:
Facility Name
Gözde Kandemir Demirci
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28179917
Citation
Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.
Results Reference
background
PubMed Identifier
27041109
Citation
Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
Results Reference
background
PubMed Identifier
26614017
Citation
Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
Results Reference
result
Citation
Gambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.
Results Reference
result

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Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems

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