Reduction of Post-endodontic Pain After RCT When Intracanal Cryotherapy is Used.

NCT03448263 | Completed DMC

• 1 other identifier: Endo 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 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.

Conditions

Post Operative Pain

Keywords

pain; post endodontic pain; root canal treatment

Outcome Measures

Primary Outcomes (1)

• 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

  24 hrs

Secondary Outcomes (1)

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

  24 hrs

Study Arms (3)

Group BF

EXPERIMENTAL

The root canals were cleaned and shaped using a #40 instrument for thin or curved canals and a #55 file for widespread canals.

Procedure: Balanced Force technique; Procedure: WaveOne technique; Procedure: Reciproc technique

Group WON

EXPERIMENTAL

WaveOne files was used to prepare narrow, straight and curved canals, and a file (40.08) was used for large and wide canals.

Procedure: Balanced Force technique; Procedure: WaveOne technique; Procedure: Reciproc technique

Reciproc instruments

EXPERIMENTAL

Reciproc instrument was used in thin and curved RC, and R40 files (40.06) were used in wide canals.

Procedure: Balanced Force technique; Procedure: WaveOne technique; Procedure: Reciproc technique

Interventions

Balanced Force technique PROCEDURE

Flex-R files sizes 15-45 taper .02 were used according to the technique on each tooth

Group BF; Group WON; Reciproc instruments

WaveOne technique PROCEDURE

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.

Group BF; Group WON; Reciproc instruments

Reciproc technique PROCEDURE

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.

Group BF; Group WON; Reciproc instruments

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 canal).

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Jose Clemente Orozco

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 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

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 the Balanced Force technique, WaveOne, and Reciproc instrument systems.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: JORGE PAREDES VIEYRA D.D.S., MsC, PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 28, 2018
• Study Start: January 4, 2018
• Primary Completion: January 5, 2018
• Study Completion: February 6, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)