Condition category
Oral Health
Date applied
16/01/2018
Date assigned
25/01/2018
Last edited
24/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Root canal treatment is a dental procedure used to treat infection at the centre of a tooth (the root canal system). Irrigation activation systems are used to flush out the root canal system. The aim of this study is to compare the pain and tenderness experienced by patients after undergoing different irrigation activation techniques.

Who can participate?
Healthy volunteers aged 18-60

What does the study involve?
The participants’ premolar teeth are randomly allocated to undergo one of five irrigation activation techniques: conventional irrigation, manual dynamic irrigation, passive ultrasonic irrigation, EndoVac irrigation, and photon-initiated photoacoustic streaming irrigation. The treatment is completed in a single session. Spontaneous pain and tenderness to percussion are assessed after 6, 24 and 48 hours.

What are the possible benefits and risks of participating?
The techniques are suited to clinical standards. The treatment does not involve any risk.

Where is the study run from?
İzmir Katip Çelebi University (Turkey)

When is the study starting and how long is it expected to run for?
January 2015 to October 2015

Who is funding the study?
İzmir Katip Çelebi University (Turkey)

Who is the main contact?
Gokhan Saygili

Trial website

Contact information

Type

Scientific

Primary contact

Mr Gokhan Saygili

ORCID ID

Contact details

İzmir Katip Çelebi University
Izmir
35020
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16-01-1618

Study information

Scientific title

Assessment of the relationship between different irrigation activation techniques and postoperative pain and tenderness to percussion

Acronym

Study hypothesis

The aim of this study was to compare the postoperative pain and tenderness to percussion experienced by patients who had been subject to contemporary irrigation activation techniques involving different mechanisms.

Ethics approval

Ethics Committee of İzmir Katip Çelebi University of Clinical Sciences, 12/11/2014, ref: 177

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Root canal treatment (endodontics)

Intervention

Vital pulp mandibular premolar teeth (single canal) were selected from either asymptomatic irreversible pulpitis such as deep dentine caries and secondary caries, or normal pulps that were referred for prosthetic reasons. 20 mandibular premolars were randomised to one of five groups: conventional irrigation (CI), manual dynamic irrigation (MDI), passive ultrasonic irrigation (PUI), EndoVac irrigation (EV) and photon-initiated photoacoustic streaming irrigation (PIPSI) techniques were applied as the means of final irrigation of the root canals. The final irrigation was performed with the five different techniques after the canals were enlarged. The endodontic treatment of the teeth was completed in a single session. The spontaneous pain and tenderness to percussion analyses were performed after 6, 24 and 48 hours. A visual analogue scale (VAS) was used to measure spontaneous pain and tenderness to percussion. The statistical analyses were performed using the Kruskal-Wallis and Mann-Whitney U tests.

The irrigation protocols are detailed in terms of both quantity and time. Concentrations of 17% EDTA and 2.5% NaOCl were used in all the groups.

Conventional irrigation (CI)
An irrigation cannula was adjusted 1 mm coronal to the working length. During the irrigation, the cannula was moved 2 mm up and down in this area. As intracanal irrigation, both 2 ml/min EDTA and 5 ml/min NaOCl were used. In this group, 2 ml EDTA and 5 ml NaOCl were used.

Manual dynamic irrigation (MDI)
The location of the injector and the quantity/time of the irrigation were the same as in the CI group. During the activation, a gutta-percha cone that was one size smaller than the master gutta-percha cone (Micro Mega, Besancon, France) was selected. The cone was adjusted 1 mm coronal to the working length and it was activated at a rate of 100 push-pull strokes per minute. In this group, 2 ml EDTA and 5 ml NaOCl were used.

Passive ultrasonic irrigation (PUI)
The location of the injector and the quantity/time of the irrigation were the same as in the CI group. While the ultrasonic (Acteon Satelec, France) activation’s sixth power setting was applied, a specific ultrasonic file (size 15/.02 taper) (Varios U files, Nakanishi, Japan) was placed 1-4 mm short of the working length and then moved up and down. While the ultrasonic activation was carried out, it was ensured that there was always solution in the canal. If there was a decrease in the intracanal solution, more solution was irrigated into the canal. In this group, 2 ml EDTA and 5 ml NaOCl were used.

EndoVac irrigation (EV)
Using an MDT, NaOCl was replenished as the irrigant in the pulp chamber after each rotary file. When irrigating with an MDT, both EDTA and NaOCl were used at 12 ml/min. Following complete shaping, a macrocannula was used in the canal with NaOCl for 30 seconds. During aspiration, the macrocannula was moved up and down until it could reach the working length. The microcannula was withdrawn 1 mm from the full working length. To prevent jams in the apical region during aspiration with the microcannula, the movements of air bubbles in the hose were observed. In this group, 2 ml EDTA and 18 ml NaOCl were used.

Photon-induced photoacoustic streaming irrigation (PIPSI)
An Er:YAG laser (Fidelis AT Fotona, Ljubljana, Slovenia) was used and a 14 mm long, 300 μm quartz laser tip was applied with 0.3 W (15 Hz and 20 mJ per pulse). As the laser system was worked, the water and air were turned off. The patient, physician and assistant all wore protective glasses. This group was irrigated with activation at the same time. When irrigating with PIPSI, both EDTA and NaOCl were used at 4 ml/min. In this group, 2 ml EDTA and 2 ml NaOCl were used.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Pain measured using a visual analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = extremely strong, maximum pain) after 6, 24 and 48 hours

Secondary outcome measures

Percussion assessments performed using the handle of a mirror by the same clinician using the same force and the same posture after 6, 24 and 48 hours

Overall trial start date

05/01/2015

Overall trial end date

30/10/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18-60
2. Male or female

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

3 patients (20 mandibular premolars)

Participant exclusion criteria

1. Systemic disease
2. Non vital pulpa
3. Pain
4. Patients who cannot wear rubber dam

Recruitment start date

16/02/2015

Recruitment end date

18/02/2015

Locations

Countries of recruitment

Turkey

Trial participating centre

İzmir Katip Çelebi University
Faculty of Dentistry
35020

Sponsor information

Organisation

İzmir Katip Çelebi University

Sponsor details

Scientific research projects unit
Cigli
Izmir
35020
Turkey

Sponsor type

University/education

Website

http://ikc.edu.tr/

Funders

Funder type

University/education

Funder name

İzmir Katip Çelebi University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This is a thesis work. This study is also aimed at publishing and distributing to the international field as soon as possible.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Gokhan Saygili.

Intention to publish date

24/04/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes