Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth (RCT2019)
Primary Purpose
Endodontic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
ProTaper Next
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease
Eligibility Criteria
Inclusion Criteria:
The inclusion limitations were:
- nonappearance of radiographic proof of apical inflammation.
- irreversible pulpitis recognized by the positive reaction to thermal tests, and
- persistent pre-operative pain due to the pulpal condition.
- Patients must be in physical and emotional wellbeing.
- Any drug used seven days' previous study.
Exclusion Criteria:
- impossibility to obtain patient's consent,
- patients younger than 18 years. Necrotic teeth and teeth with periapical injury, root resorption,
- Patients rejecting to join the research, those with issues with single-visit RCT, those consuming a specific kind of medicine such as painkillers or NSAIDs, and participants with some unrestrained systemic ailment were excluded too.
Sites / Locations
- Jorge Paredes Vieyra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ProTaper Next group
WaveOne Gold group
Arm Description
Clean and shape the necrotic canals with ProTaper instruments. In case of pain or inflammation 800mg Ibuprofen 3 times a day
Clean and shape the necrotic canals with Wave One Gold instruments. In case of pain or inflammation 800mg Ibuprofen 3 times a day
Outcomes
Primary Outcome Measures
Endotoxin test for both groups
measure endotoxin concentrations in the root canals before and after chemomechanical procedures. 24 hrs after root canal treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04200638
First Posted
December 8, 2019
Last Updated
December 12, 2019
Sponsor
Universidad Autonoma de Baja California
1. Study Identification
Unique Protocol Identification Number
NCT04200638
Brief Title
Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth
Acronym
RCT2019
Official Title
Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth With Apical Periodontitis After Two-visit RCT
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
September 13, 2019 (Actual)
Study Completion Date
December 6, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Baja California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext
Endodontics procedure steps:
Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.
2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.
2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator.
3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.
Lab procedures to identify microorganisms
Detailed Description
The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext
Endodontics procedure steps:
Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.
2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.
2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator.
3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.
4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone).
5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique.
Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant, investigator and assessor.The trial design of this study will be a prospective, parallel.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProTaper Next group
Arm Type
Experimental
Arm Description
Clean and shape the necrotic canals with ProTaper instruments. In case of pain or inflammation 800mg Ibuprofen 3 times a day
Arm Title
WaveOne Gold group
Arm Type
Experimental
Arm Description
Clean and shape the necrotic canals with Wave One Gold instruments. In case of pain or inflammation 800mg Ibuprofen 3 times a day
Intervention Type
Diagnostic Test
Intervention Name(s)
ProTaper Next
Intervention Description
The canal fluid sample before and after will evaluate after root canal instrumentation
Primary Outcome Measure Information:
Title
Endotoxin test for both groups
Description
measure endotoxin concentrations in the root canals before and after chemomechanical procedures. 24 hrs after root canal treatment
Time Frame
Endotoxin from fluid in ProTaper Next group
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18 to 65 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion limitations were:
nonappearance of radiographic proof of apical inflammation.
irreversible pulpitis recognized by the positive reaction to thermal tests, and
persistent pre-operative pain due to the pulpal condition.
Patients must be in physical and emotional wellbeing.
Any drug used seven days' previous study.
Exclusion Criteria:
impossibility to obtain patient's consent,
patients younger than 18 years. Necrotic teeth and teeth with periapical injury, root resorption,
Patients rejecting to join the research, those with issues with single-visit RCT, those consuming a specific kind of medicine such as painkillers or NSAIDs, and participants with some unrestrained systemic ailment were excluded too.
Facility Information:
Facility Name
Jorge Paredes Vieyra
City
Tijuana
State/Province
BC
ZIP/Postal Code
22000
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Clean and shape with two kinds of Ni-Ti instruments
Citations:
PubMed Identifier
22892729
Citation
Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
Results Reference
background
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Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth
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