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Pain Reduction Using Two Cold Irrigating Protocols in Teeth With Vital Pulps. (EP18)

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
For the Group A. Applied Cryotherapy at 6 oC
For the Group B. Applied Cryotherapy at 2.5 oC
Control Group (CG). Applied irrigant at room temperature
Sponsored by
Universidad Autonoma de Baja California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring post-endodontic pain, pain, criotherapy, cold irrigation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- absence of radiographic sign of apical pathosis and a diagnosis of irreversible pulpitis (IP) and vital pulp 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 root canal therapy done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started.

Exclusion Criteria:

  • the necessity for retreatment

    • pregnancy
    • impossibility to obtain patient's approval
    • patients who didn't complete inclusion necessities for the research
    • 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 Apical patency).

Root fractures

Sites / Locations

  • Jorge Paredes Vieyra
  • Jorge Paredes Vieyra
  • Jose Clemente

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A. Cold Protocol with 6 oC

Group B. Cold Protocol with 2.5 oC

CG. Room temperature Protocol

Arm Description

Use of 20 mL cold (6 oC) sterile saline solution. After the clinical procedure cryotherapy was applied. 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System for five minutes.

Use of 20 mL cold (2.5 oC) sterile saline solution After the procedure cryotherapy was applied. 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.

Use of 20 mL (at room temperature) sterile saline solution The group will receive irrigant at room temperature. 5mL of 17% EDTA and 20 mL of sterile saline usingmetallic micro-cannula included in the Endo Vac System for five minutes.

Outcomes

Primary Outcome Measures

Evaluate the post-endodontic pain after one-visit after the root canal treatment with reciprocating NiTi system.
Pain was evaluated after 24, 48 and 72 hrs after instrumentation with reciproc NiTi instruments, the 80 canals were flushed with cold irrigants (6 and 2.5 oC). According to the VAS table provided to the participants

Secondary Outcome Measures

Evaluate the Use of intracanal cryotherapy on post-endodontic pain after single-visit RC.
Pain reduction was evaluated after a final irrigation with cold 5cc of (2.5 oC- 6 oC) 17% EDTA gently delivered to the WL using a cold (2.5- 6 oC) sterile metallic micro cannula. According to the VAS table provided to the participants

Full Information

First Posted
May 10, 2018
Last Updated
June 14, 2018
Sponsor
Universidad Autonoma de Baja California
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1. Study Identification

Unique Protocol Identification Number
NCT03559127
Brief Title
Pain Reduction Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
Acronym
EP18
Official Title
Pain Reduction After One-visit Root Canal Treatment Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
April 30, 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 clinical research was to relate the incidence of post-endodontic pain after one-visit root canal treatment using two cold protocols of irrigation. Methodology: All 240 patients had upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons detected with only vital pulps (symptomatic or asymptomatic condition). Of the sample of 240 teeth, were selected to different manner to irrigate. Reciproc instruments were used with a micro motor (VDW, Munich Germany). Final irrigation with cold (6oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
Detailed Description
RCT was done in one-visit. Topical anesthetic (Anestesia Topica, Astra Mexico) was applied before infiltration. Patients received 2 carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In circumstances in which additional anesthesia was required, intra-ligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the solution was injected by slow and gradual local infiltration. For the lower teeth, 1 of the carpules was used for an inferior alveolar nerve block and the other 1 for a gentle labial infiltration near the tooth to be treated. Rubber dam was placed and the tooth was clean with 5.25% NaOCl. Preparation of the access cavity was achieved using sterile # 331 bur (Dentsply Int, York, PA), with high-speed and refrigeration. 5.25% NaOCl was employed to disinfect the coronal access. The canals were cautiously probed with #10 K-type file (Flex-R files, Moyco/Union Broach, York PA, USA). 17% EDTA (Roth International, Chicago, IL) irrigant was administered at the entrance of the canals. Working length was established with a #15 k-file and the Root ZX electronic apex locator (J Morita, Irvine CA, USA), and confirmed radiographically (Schick Technologies, NY, USA). Cervical and middle thirds of the canal was flared with a K3XF 25/10 rotary instrument (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was flushed with 3 mL 5.25% sodium hypochlorite (NaOCl). A glide path to the WL was then established. Preparations of the canals were completed with an electric motor (VDW Silver Motor, VDW, Munich Germany). Torque and rotation were predetermined for each reciproc instrument, and were used in continuous reciprocating mode. Dentinal remains were removed from the instrument with a sterile gauze, immediately to the instrument change after two-three pull in-and-pull out (pecking) movements (Reciproc) following the manufacturers' recommendations. Each root canal was flushed with 2.5mL 2.6% NaOCl. Irrigation was achieved 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 getting the WL after each instrument insertion. A size #10 K file was used to maintain WL after each Reciproc instrument. The established WL was checked repeatedly throughout the clinical procedures. After instrumentation, the root canals were flushed with 1 mL 2.6% NaOCl, activated ultrasonically; It was achieved by means of an Irrisafe ultrasonic 20.00 tip (Satelec, Merignac, France) at 50% power of the Mini-Endo ultrasonic device (Kerr Endo) with the tip placed three mm from the WL for thirty seconds per root canal. Irrigating Protocols Group A. The R25 (size 25/ .08) instrument was used in thin and curved canals, and R40 files (40/ .06) were used in broad root canals. Three in/out pecking cycles were employed with a fullness of not more than 3 mm until reaching the established WL. Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes. Group B. Canals were prepared as in group A, Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes. Control Group (CG). 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 cycles were applied with a distance of not more than three mm until getting the established WL. Reciproc instruments were employed in one tooth only (single use). Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes. Each experimental and control group were flushed with the irrigant described above. Care was taken to confirm that the metallic cannula would aspirate properly by noticing the system's translucent evacuation duct. In case there was some obstacle, the metallic device was rapidly replaced. Recapitulation of working length was performed again by using an apex locator as described before using #35 and #40 files. The root canals were desiccated with disinfected paper cones and filled at the same visit. Gutta-percha points (Dentsply Maillefer) were laterally condensed with #25 nickel-titanium spreaders (Dentsply Maillefer) and AH-plus as the sealer (Dentsply Maillefer). The access cavities were etched and fixed with Fuji IX (GC Corp, Tokyo, Japan). After these irrigation regimens, the patients were warned of the possible occurrence of pain for hours following RCT and received an evaluation form (VAS questionnaire) to be completed and give it back 72 hours after. In it, they confirmed the presence/absence of pain. The pain level was measured using a validated pain scale known as the VAS (Hawker et al. 2011). The VAS scale is a continuous measure comprised of a horizontal line, which is 10 cm in length. For pain intensity, the VAS is anchored by ''no pain'' (score of 0) and ''pain as bad as it could be'' (score of 10). The cut points on the pain VAS are no pain (0-0.5 cm), mild pain (0.6-4.0 cm), moderate pain (0.45-7.4 cm), and severe pain (7.5-10 cm) (Jensen et al. 2003). The pain VAS was completed by the patients. The patients were asked to put a mark perpendicular to the pain VAS line at the point that indicated their pain severity during the 3 days after the endodontic treatment. 234 of the two hundred and forty examinations were properly returned. 77 belonged to the group A, 78 to group B and 79 to the Control group. The missing 6 questionnaires were returned one day later and were incorporated in the examination. The outcomes for the groups A, B and CG related to existence (yes/no), kind (mild, moderate, severe), and period (days) of pain were evaluated, and related to the following diagnostic factors: vital teeth, presence or absence of pre-operative pain, group of teeth, or ubication, age and sex, presence of occlusal contacts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
post-endodontic pain, pain, criotherapy, cold irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Random Selection of different temperature of irrigating solution groups. Of the sample of 240 teeth, 80 were randomly assigned to the one of the 3 irrigating protocols. Treatment was performed by 3 experienced endodontists; each prepared and irrigated 80 teeth.
Masking
ParticipantInvestigator
Masking Description
Certified endodontist (3) trained in the procedures, devices, and irrigating systems investigated took part in the research. All experts tracked a pre-established procedure for Reciproc instrument systems and cryotherapy.
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A. Cold Protocol with 6 oC
Arm Type
Experimental
Arm Description
Use of 20 mL cold (6 oC) sterile saline solution. After the clinical procedure cryotherapy was applied. 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
Arm Title
Group B. Cold Protocol with 2.5 oC
Arm Type
Experimental
Arm Description
Use of 20 mL cold (2.5 oC) sterile saline solution After the procedure cryotherapy was applied. 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
Arm Title
CG. Room temperature Protocol
Arm Type
Experimental
Arm Description
Use of 20 mL (at room temperature) sterile saline solution The group will receive irrigant at room temperature. 5mL of 17% EDTA and 20 mL of sterile saline usingmetallic micro-cannula included in the Endo Vac System for five minutes.
Intervention Type
Procedure
Intervention Name(s)
For the Group A. Applied Cryotherapy at 6 oC
Other Intervention Name(s)
Cold irrigant used after root canal treatment
Intervention Description
Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
For the Group B. Applied Cryotherapy at 2.5 oC
Other Intervention Name(s)
Cold irrigant used after RCT
Intervention Description
Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
Intervention Type
Procedure
Intervention Name(s)
Control Group (CG). Applied irrigant at room temperature
Other Intervention Name(s)
Use of Saline solution at room temperature
Intervention Description
Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes.
Primary Outcome Measure Information:
Title
Evaluate the post-endodontic pain after one-visit after the root canal treatment with reciprocating NiTi system.
Description
Pain was evaluated after 24, 48 and 72 hrs after instrumentation with reciproc NiTi instruments, the 80 canals were flushed with cold irrigants (6 and 2.5 oC). According to the VAS table provided to the participants
Time Frame
24 hours to 72 hours
Secondary Outcome Measure Information:
Title
Evaluate the Use of intracanal cryotherapy on post-endodontic pain after single-visit RC.
Description
Pain reduction was evaluated after a final irrigation with cold 5cc of (2.5 oC- 6 oC) 17% EDTA gently delivered to the WL using a cold (2.5- 6 oC) sterile metallic micro cannula. According to the VAS table provided to the participants
Time Frame
24 hours to 72 hours

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: - absence of radiographic sign of apical pathosis and a diagnosis of irreversible pulpitis (IP) and vital pulp 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 root canal therapy done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started. Exclusion Criteria: the necessity for retreatment pregnancy impossibility to obtain patient's approval patients who didn't complete inclusion necessities for the research 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 Apical patency). Root fractures
Facility Information:
Facility Name
Jorge Paredes Vieyra
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22000
Country
Mexico
Facility Name
Jorge Paredes Vieyra
City
Tijuana
State/Province
Baja Califronia
ZIP/Postal Code
22000
Country
Mexico
Facility Name
Jose Clemente
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
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Pain Reduction Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.

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