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
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