Reduction of Post-endodontic Pain After RCT When Intracanal Cryotherapy is Used. (PEP)
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Balanced Force technique
WaveOne technique
Reciproc technique
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring pain, post endodontic pain, root canal treatment
Eligibility Criteria
Inclusion Criteria:
The principal inclusion parameters were:
- absence of radiographic sign of apical periodontitis and a diagnosis of irreversible pulpitis (IP) established by affirmative response to hot and cold examinations.
- Thermal pulp examination was achieved by the corresponding author, and radiographic analysis was established by 3 certified endodontists.
- Clinical requirements were established on the next conditions: 1) The purposes and necessities of the research were spontaneously accepted. 2) Clinical Management was pointed to patients in physical and mental well-being. 3) All teeth had vital pulps and absence of apical periodontitis. 4) Positive thermal stimulation with EndoIce (Hygenic Corp, Akron, OH). 5) Teeth with enough coronal structure for rubber dam isolation. 6) No RCT done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started
Exclusion Criteria:
Exclusion parameters were:
- the necessity for retreatment
- gravidity
- impossibility to obtain patient's approval
- patients who didn't complete inclusion necessities
- a history of medication for chronic pain or those compromising the immune response
- patients younger than 18 years and the existence of mishaps or difficulties during RCT (calcified canals, impracticality of achieving AP in any canal).
Sites / Locations
- Jose Clemente Orozco
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group BF
Group WON
Reciproc instruments
Arm Description
The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals.
WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals.
Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals.
Outcomes
Primary Outcome Measures
Evaluate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and two reciprocating system.
Post-endodontic pain was evaluated when the RCT developed with hand and rotary instruments
Secondary Outcome Measures
Use of intracanal cryotherapy on post-endodontic pain after single-visit RC
A final irrigation after root canal treatment was made with cold 3cc of (6oC) 17% EDTA gently delivered to the WL using a cold (6oC) sterile metallic micro cannula.
Full Information
NCT ID
NCT03448263
First Posted
February 15, 2018
Last Updated
February 27, 2018
Sponsor
Universidad Autonoma de Baja California
1. Study Identification
Unique Protocol Identification Number
NCT03448263
Brief Title
Reduction of Post-endodontic Pain After RCT When Intracanal Cryotherapy is Used.
Acronym
PEP
Official Title
Reduction of Post-endodontic Pain After Single-visit RCT Using Balanced Force and Two Reciprocating System When Intracanal Cryotherapy is Used.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this research was to relate the occurrence of post-endodontic pain after single-visit RCT using Balanced Force technique and two reciprocating system when cryotherapy is used. Methodology: All 216 patients had upper or lower molar, premolar or anterior teeth selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the sample of 216 teeth, were selected to the 3 instrumentation methods. For hand instrumentation, Balanced Force were used. All canals were clean and shaped with hand Flex-R files (fMoyco/Union Broach, York PA, USA). For mechanical shaping, all instruments were used with a micro motor (VDW, Munich Germany). WaveOne and Reciproc instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.
Detailed Description
Patient selection Two hundred and sixteen of 245 patients (119 women and 97 men) aged 18-65 years were incorporated in this research while 29 were excluded as not meeting the inclusion criteria. (Fig. 1). Sample size estimate was achieved according with a method for this specific purpose (Cochran's method, 1986). Therefore, the 56 teeth allocated to each group were adequate to confirm an essential sample size.
For hand instrumentation, the Balanced Force technique was used. All root canals were shaped with hand Flex-R files (Moyco/Union Broach, York PA, USA). Gates-Glidden drills (Dentsply Maillefer) sizes #2 and #3 were used at the orifice of the root canals. For mechanical preparations, all instruments were used with a micro motor (VDW Silver Motor, VDW, Munich Germany). Torque and rotation were preset for each Reciproc or WaveOne instrument. Rotary Ni-Ti instruments were used in continuous brushing rotary motion and reciprocating mode respectively.
Dentinal debris was eliminated from the file with a gauze, instantaneously to the instrument change (WaveOne) or after 2-3 in-and-out (pecking) movements (Reciproc) following the manufacturers' recommendations. Each root canal was irrigated with 2.5mL 2.6% NaOCl. Irrigation was performed using a 24-gauge needle (Max-I-Probe; Tulsa Dental, York, PA) and a 31-G NaviTip needle (Ultradent Products Inc, South Jordan, UT) when reaching the WL after each instrument insertion.
Group BF. For the Balanced Force group, the root canals were shaped and shaped using a #40 instrument for thin or curved canals and a #55 file for wide canals.
Group WON. For the WaveOne group, a file size 25/.08 was used to prepare narrow, straight and curved canals, and a file size 40/.08 was used for large and wide canals.
Three in-and-out pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length.
Group REC. The R25 (size 25/ .08) instrument was used in thin and curved root canals, and R40 files (40/ .06) were used in wide root canals. Three in-and-out pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
pain, post endodontic pain, root canal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Random Selection of instrumentation groups. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 instrumentation methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per technique.
Masking
ParticipantInvestigator
Masking Description
Certified endodontists trained in the procedures, devices, and systems investigated took part in the research. All experts tracked a pre-established procedure for the Balanced Force technique, WaveOne, and Reciproc instrument systems.
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group BF
Arm Type
Experimental
Arm Description
The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals.
Arm Title
Group WON
Arm Type
Experimental
Arm Description
WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals.
Arm Title
Reciproc instruments
Arm Type
Experimental
Arm Description
Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals.
Intervention Type
Procedure
Intervention Name(s)
Balanced Force technique
Intervention Description
Flex-R files sizes 15-45 taper .02 were used according to the technique on each tooth
Intervention Type
Procedure
Intervention Name(s)
WaveOne technique
Intervention Description
WaveOne instrument was used to prepare narrow, straight and curved canals, and file (40.08) was used for large canals.
Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL.
Intervention Type
Procedure
Intervention Name(s)
Reciproc technique
Intervention Description
Reciproc files were used in wide canals. Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL.
Primary Outcome Measure Information:
Title
Evaluate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and two reciprocating system.
Description
Post-endodontic pain was evaluated when the RCT developed with hand and rotary instruments
Time Frame
24 hrs
Secondary Outcome Measure Information:
Title
Use of intracanal cryotherapy on post-endodontic pain after single-visit RC
Description
A final irrigation after root canal treatment was made with cold 3cc of (6oC) 17% EDTA gently delivered to the WL using a cold (6oC) sterile metallic micro cannula.
Time Frame
24 hrs
10. Eligibility
Sex
All
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 principal inclusion parameters were:
absence of radiographic sign of apical periodontitis and a diagnosis of irreversible pulpitis (IP) established by affirmative response to hot and cold examinations.
Thermal pulp examination was achieved by the corresponding author, and radiographic analysis was established by 3 certified endodontists.
Clinical requirements were established on the next conditions: 1) The purposes and necessities of the research were spontaneously accepted. 2) Clinical Management was pointed to patients in physical and mental well-being. 3) All teeth had vital pulps and absence of apical periodontitis. 4) Positive thermal stimulation with EndoIce (Hygenic Corp, Akron, OH). 5) Teeth with enough coronal structure for rubber dam isolation. 6) No RCT done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started
Exclusion Criteria:
Exclusion parameters were:
the necessity for retreatment
gravidity
impossibility to obtain patient's approval
patients who didn't complete inclusion necessities
a history of medication for chronic pain or those compromising the immune response
patients younger than 18 years and the existence of mishaps or difficulties during RCT (calcified canals, impracticality of achieving AP in any canal).
Facility Information:
Facility Name
Jose Clemente Orozco
City
Tijuana
State/Province
BC
ZIP/Postal Code
22000
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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
result
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Reduction of Post-endodontic Pain After RCT When Intracanal Cryotherapy is Used.
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