NCT03424655

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 three reciprocating system when AP is conserved. Methodology: All 224 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 224 teeth, 56 were selected to the 4 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). Twisted files adaptive, WaveOne and Reciproc instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

February 7, 2018

Status Verified

January 1, 2018

Enrollment Period

1 day

First QC Date

January 18, 2018

Last Update Submit

January 31, 2018

Conditions

Keywords

post -endodontic painendodontic painpain

Outcome Measures

Primary Outcomes (1)

  • Use of intracanal cryotherapy on post-endodontic pain after single-visit RCT using manual and reciprocating systems when Apical Patency is conserved.

    Relate the post-endodontic pain after single-visit After the root canal treatment with Balanced Force technique and three reciprocating system.

    24 hrs

Secondary Outcomes (1)

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

    24 hrs

Study Arms (4)

Group TFA

EXPERIMENTAL

Twisted files were used serially with a single controlled motion according to the manufacturer's instructions.

Procedure: Twisted File Adaptive

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: Balance Force

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: WaveOne

Group REC

EXPERIMENTAL

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

Procedure: Reciproc technique

Interventions

Twisted file adaptive SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) were used serially with a single controlled motion according to the manufacturer's instructions.

Group TFA
Balance ForcePROCEDURE

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

Group BF
WaveOnePROCEDURE

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 WON

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 REC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, 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, Twisted File Adaptive, WaveOne, and Reciproc instrument systems.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: teeth selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the sample of 224 teeth, 56 were selected to the 4 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). Twisted files adaptive, WaveOne and Reciproc instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Jorge Paredes Vieyra D.D.S., MsC, PhD

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 7, 2018

Study Start

November 12, 2017

Primary Completion

November 13, 2017

Study Completion

November 14, 2017

Last Updated

February 7, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

This clinical research took place at the University Autonomous of Baja California, School of Dentistry, Tijuana, Mexico. The subjects review committee accepted the research, and conducted in accordance with ethical principles (including the World Medical Association Declaration of Helsinki).

Locations