Reduction of Post-endodontic Pain After 3 Irrigation Regime

NCT03559140 | Completed DMC

• 1 other identifier: post endodontic pain 2018
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research was to relate the occurrence of post-endodontic pain after single-visit RCT using there irrigating regime. 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 just one method for instrumentation and different manner to irrigate. All instruments were used with a micro motor (VDW, Munich Germany). Reciproc instruments. Final irrigation with cold (8oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.

Conditions

Post-operative Pain

Keywords

post-endodontic pain; pain; root canal treatment; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Evaluate the post-endodontic pain after 24 hrs,48 and 72 hrs.

  Post-endodontic pain was evaluated after root canal treatment in order to identify in 216 patients: none, mild or severe pain.

  24 hours to 72 hours

Secondary Outcomes (1)

• Evaluate the effect of intracanal cryotherapy on post-endodontic pain after root canal treatment.

  24 hours to 72 hours

Study Arms (3)

Group A

EXPERIMENTAL

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. After the procedure cryotherapy will be applied as follows: Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes

Procedure: Applied saline solution at 8oC (Cryotherapy )

Group B

EXPERIMENTAL

Canals were prepared as in group A, Patients assigned to this group receive (application of criotherapy) A final irrigation will be applied with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. was applied. as follows: Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes

Procedure: Applied saline solution at 2.5 oC (Cryotherapy group)

Control Group (CG)

EXPERIMENTAL

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. Reciproc instruments were used in one tooth only (single use). The group will receive the irrigant solution at room temperature. as follows: they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.

Procedure: Applied saline solution at room temperature (No cryotherapy)

Interventions

Applied saline solution at 2.5 oC (Cryotherapy group) PROCEDURE

Patients assigned to this group will receive a final irrigation (application of cryotherapy) with 5 mL cold (8oC) 17% EDTA followed with 20 mL cold (8oC) sterile saline solution delivered to the WL using a cold (8oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.

Group B

Applied saline solution at 8oC (Cryotherapy ) PROCEDURE

Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.

Group A

Applied saline solution at room temperature (No cryotherapy) PROCEDURE

Patients assigned to this control group were treated identically to the experimental groups, except that they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.

Control Group (CG)

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 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

You may not qualify if:

• the necessity for retreatment
• gravidity
• 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 AP in any can

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Jorge Paredes Vieyra

Tijuana, Baja Califronia, 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 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Certified endodontists trained in the procedures, devices, and 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: Chairman of Post graduate Programs in Dentistry

Model Details: Random Selection of instrumentation groups. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 irrigating methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per technique.

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: June 15, 2018
• Study Start: January 4, 2018
• Primary Completion: January 5, 2018
• Study Completion: March 28, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)