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

NCT03559127 | Completed DMC

• 1 other identifier: Pain after RCT 2018
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Operative Pain

Keywords

post-endodontic pain; pain; criotherapy; cold irrigation

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours to 72 hours

Secondary Outcomes (1)

• Evaluate the Use of intracanal cryotherapy on post-endodontic pain after single-visit RC.

  24 hours to 72 hours

Study Arms (3)

Group A. Cold Protocol with 6 oC

EXPERIMENTAL

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.

Procedure: For the Group A. Applied Cryotherapy at 6 oC

Group B. Cold Protocol with 2.5 oC

EXPERIMENTAL

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.

Procedure: For the Group B. Applied Cryotherapy at 2.5 oC

CG. Room temperature Protocol

EXPERIMENTAL

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.

Procedure: Control Group (CG). Applied irrigant at room temperature

Interventions

For the Group A. Applied Cryotherapy at 6 oC PROCEDURE

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.

Also known as: Cold irrigant used after root canal treatment

Group A. Cold Protocol with 6 oC

For the Group B. Applied Cryotherapy at 2.5 oC PROCEDURE

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.

Also known as: Cold irrigant used after RCT

Group B. Cold Protocol with 2.5 oC

Control Group (CG). Applied irrigant at room temperature PROCEDURE

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.

Also known as: Use of Saline solution at room temperature

CG. Room temperature Protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• the necessity for retreatment
• pregnancy
• impossibility to obtain patient's approval
• 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

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (3)

Jorge Paredes Vieyra

Tijuana, Baja Califronia, 22000, Mexico

Location

Jorge Paredes Vieyra

Tijuana, Estado de Baja California, 22000, Mexico

Location

Jose Clemente

Tijuana, Estado de Baja California, 22000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 22892729 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MsC, PhD

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 15, 2018
• Study Start: March 7, 2018
• Primary Completion: March 8, 2018
• Study Completion: April 30, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)