Condition category
Oral Health
Date applied
15/06/2019
Date assigned
28/06/2019
Last edited
26/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The knowledge of the mechanisms responsible for triggering the painful response in endodontics (treatment of tooth pulp) is essential to perform accurate procedures, avoiding the possible causes of pain. This study determined the pain levels of patients submitted to endodontic treatment, with or without the apical foramen enlargement, using chorexidine or sodium hypochlorite with and without agitation with XP- endo Finisher.

Who can participate?
Patients aged over 18, requiring endodontic treatment at the trial centre.

What does the study involve?
Participants will undergo endodontic treatment using one of seven similar methods. Following treatment, pain level will be assessed to determine which method produces the least pain.

What are the possible benefits and risks of participating?
Benefits: Participants will receive the necessary care free of charge and with high-quality materials and equipment. This treatment will improve oral health and restore the function of the affected tooth.
Risks: instrument fractures (breakage of instrument), root perforation, extravasation of the chemical used causing irritation of affected tissues, post-treatment pain and swelling. These are the main risks during the treatment of the canal

Where is the study run from?
Pontifical Catholic University of Paraná, Brasil

When is the study starting and how long is it expected to run for?
February to May 2019

Who is funding the study?
Pontifical Catholic University of Paraná

Who is the main contact?
Prof. Leonardo Alexandre Fernandes
alexandre.leonardo@pucpr.edu.br

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leonardo Alexandre Fernandes

ORCID ID

http://orcid.org/0000-0002-5267-9751

Contact details

Alvaro Andrade 358
Curitiba
80610240
Brazil
+55 41 3271-1555
alexandre.leonardo@pucpr.edu.br

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3056118

Study information

Scientific title

Endodontic post-treatment pain level with variation of foraminal enlargement and irrigation solution with and without agitation with XP-endo Finisher: a randomized clinical trial

Acronym

Study hypothesis

The technique that uses sodium hypochlorite, being more irritating causes more pain in the postoperative endodontic

Ethics approval

Approved 04/12/2018, Pontifical Catholic University of Paraná (Rua Imaculada Conceição 1155, Prado Velho, Curitiba, Brasil; +55 41 3271-2103; nep@pucpr.br), ref: 3056118

Study design

Double-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Caries with pulp exposure

Intervention

In this double-blind randomized clinical trial, participants were divided into 7 groups: SH2.5 (2.5% sodium hypochlorite) (n = 30), CHX2.0 (chlorhexidine 2.0%) (n = 30 ), CHX2,0EF (chorhexidine 2.0% with foraminal enlargement) (SH = 0.5), SH2,5EF (sodium hypochlorite 2.5% with foraminal enlargement) (SH) and SH2,5XPF (sodium hypochlorite 2 (5% agitated with XP-endo Finisher) (n = 20), SH2,5XPF-EF (2.5% sodium hypochlorite agitated with XP-endo Finisher and with foraminal enlargement) (n = 15) and SH2,5PC sodium hypochlorite 2.5% after orofacial cancer) (n = 15). The teeth were instrumented with the Wave One Gold Mediun file, filled with AH Plus cement and the closed cavity with cotosol. Randomisation was done to eliminate bias and to equalize the distribution of patients in the groups using the Excel computer program with a random list of numbers from 1 to 7. In case the same patient had more than one element to be treated, the tooth located in the upper right hemi-arch was the first, followed by hemi-upper left arch, lower right and lower left, respecting the minimum limit of 10 days and absence of pain between the treatment of one tooth and another. Only the operator who performed the treatment knew which technique was being used.

Endodontic treatments were performed by a single operator specialized in endodontics. After the clinical examination, the cold test (Endo-frost; Coltene-Whaledent, Langenau, Germany) was used to determine the vitality of the pulp followed by the presence or absence of bleeding of the root canals during the preparation of endodontic access. If there was no painful response after 5 seconds of applying a cotton ball and not bleeding, the teeth were classified as necrotic. The treatment was performed in all patients in a single visit.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Pain measured by a visual analogue scale, 6, 12, 24, 72 hours and 7 days after completion of treatment

Secondary outcome measures

Use of antidepressants and previous treatment of radiotherapy head and neck from patient records.

Overall trial start date

28/03/2018

Overall trial end date

31/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Older than 18 years
2. Need endodontic treatment
3. Negative response to vitality tests
4. The included teeth were monoradicadic and biradicculated, superior and inferior, with or without image suggestive of periapical lesion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170

Participant exclusion criteria

1. Acute apical pain and/or abscess
2. Endodontic retreatment
3. Pregnant women on antibiotics, corticosteroids or analgesics
4. Complications from systemic diseases
5. Anatomic diameter greater than the K-type file 20 mm or less than the K-type file 10, in addition to teeth with resorption and open apex

Recruitment start date

18/02/2019

Recruitment end date

28/05/2019

Locations

Countries of recruitment

Brazil

Trial participating centre

Pontifical Catholic University of Paraná
R. Imac. Conceição, 1155 Prado Velho
Curitiba
80215-901
Brazil

Sponsor information

Organisation

Pontifical Catholic University of Paraná

Sponsor details

R. Imac. Conceição
1155 - Prado Velho
Curitiba
80215-901
Brazil
5541984012345
leonardofernandes@outlook.com

Sponsor type

University/education

Website

https://www.pucpr.br

Funders

Funder type

University/education

Funder name

Pontificia Universidade Católica do Paraná

Alternative name(s)

Pontifical Catholic University of Paraná, PUCPR

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Brazil

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

30/07/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/06/2019: Trial’s existence confirmed by Pontifical Catholic University of Paraná