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Trial record 2 of 275657 for:    ALL

Reduction of Post-endodontic Pain After 3 Irrigation Regime (RPEP)

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ClinicalTrials.gov Identifier: NCT03559140
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Jorge Paredes Vieyra, Universidad Autonoma de Baja California

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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Procedure: Applied saline solution at 2.5 oC (Cryotherapy group) Procedure: Applied saline solution at 8oC (Cryotherapy ) Procedure: Applied saline solution at room temperature (No cryotherapy) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
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 Reciproc instrument systems and cryotherapy.
Primary Purpose: Treatment
Official Title: Reduction of Post-endodontic Pain After Single-visit RCT Using Three Irrigating Regimens.
Actual Study Start Date : January 4, 2018
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : March 28, 2018

Arm Intervention/treatment
Experimental: Group A

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 )
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.

Experimental: Group B

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)
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.

Experimental: 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 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)
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.




Primary Outcome Measures :
  1. Evaluate the post-endodontic pain after 24 hrs,48 and 72 hrs. [ Time Frame: 24 hours to 72 hours ]
    Post-endodontic pain was evaluated after root canal treatment in order to identify in 216 patients: none, mild or severe pain.


Secondary Outcome Measures :
  1. Evaluate the effect of intracanal cryotherapy on post-endodontic pain after root canal treatment. [ Time Frame: 24 hours to 72 hours ]
    Post endodontic pain was evaluated after a final irrigation with cold 5cc of (2.5-8oC) 17% EDTA gently delivered to the WL using a cold (2.5-8oC) sterile metallic micro cannula.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 can

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559140


Locations
Mexico
Jorge Paredes Vieyra
Tijuana, Baja Califronia, Mexico, 22000
Sponsors and Collaborators
Universidad Autonoma de Baja California

Publications of Results:
Responsible Party: Jorge Paredes Vieyra, Chairman of Post graduate Programs in Dentistry, Universidad Autonoma de Baja California
ClinicalTrials.gov Identifier: NCT03559140     History of Changes
Other Study ID Numbers: post endodontic pain 2018
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jorge Paredes Vieyra, Universidad Autonoma de Baja California:
post-endodontic pain
pain
root canal treatment
cryotherapy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pharmaceutical Solutions