Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02632513 |
| Other study ID # |
PGIDS/IEC/2014/120 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 10, 2015 |
| Last updated |
December 11, 2015 |
| Start date |
May 2014 |
| Est. completion date |
October 2015 |
Study information
| Verified date |
December 2015 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
India: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to compare the success after endodontic treatment performed with
or without continuous ultrasonic irrigation.
70 Mandibular molars with diagnosis of pulpal necrosis and with periapical radiolucency were
randomly assigned into two treatment groups- continuous ultrasonic irrigation (CUI) and
syringe irrigation (SI). Standard nonsurgical endodontic treatment was performed on both
groups under rubber dam isolation with 0.02 taper ISO stainless steel hand files using step
back technique. In both groups, 5 ml of 5.25% sodium hypochlorite was used as irrigant after
each instrument. After root canal instrumentation, canals were irrigated with 5 ml of 17%
EDTA solution for 1 minute. In SI group, canals were flushed with 15ml of 5.25% sodium
hypochlorite using a 27 gauge needle while final irrigant was delivered using a continuous
ultrasonic irrigation device in CUI group. An inter-appointment dressing of calcium
hydroxide was given and patient was recalled after one week and canals were obturated with
the Gutta Percha. Immediate postoperative radiograph was then taken, followed by radiographs
at 3, 6, 9 and 12 months.
Description:
Title: Effect of passive ultrasonic irrigation on success of primary endodontic treatment
Introduction:
It is well established that apical periodontitis is caused due to microbial invasion of root
canal space. It is an inflammatory disease process comprising host responses to infection of
the root canal system of the affected tooth. So, it becomes important to render the root
canals free of microorganisms and pathological debris to treat apical periodontitis.
Mechanical instrumentation plays an important role in removing microorganisms from the root
canal system but it is incapable of rendering canal completely free of bacteria. The
intricacies of the root canal system such as fins, isthmi, apical ramifications hinder its
complete debridement as these areas are inaccessible to mechanical instrumentation. These
complexities continue to harbour bacteria, necrotic tissue and debris and results in
persistent periapical inflammation. Thus adjunctive use of root canal irrigant becomes
important. Mechanical cleaning of root canals aided by antimicrobial irrigation, thus, are
two key elements that help in reducing the bacterial load of root canal and treating apical
periodontitis. Irrigation forms an integral part of chemomechanical preparation by
facilitating the removal of bacteria, debris and necrotic tissue, especially from areas
beyond the reach of root canal instruments. Sodium hypochlorite is recommended as the main
irrigant during root canal treatment because of its antimicrobial efficacy as well as its
tissue-dissolving capacity but its effectiveness in root canal depends on the irrigant's
penetration along the full length of the canal and on irrigant exchange. Although
conventional syringe delivery is a well accepted technique of irrigation but it delivers
solutions no more than 0-1.1 mm beyond the needle tip thereby limiting irrigant penetration.
In addition air entrapment at apical third produces a vapor lock effect, thus impeding the
flow of irrigant into the apical region and adequate debridement of the canal system.16
Previous studies have shown that root canals still have detectable levels of cultivable
bacteria following chemomechanical procedures with sodium hypochlorite as an irrigant.
Consequently, different irrigant agitation techniques have been proposed to increase
cleaning efficacy, mechanically and chemically, by enhancing the irrigation dynamics. One
such technique is ultrasonic activation of root canal irrigant.
Passive ultrasonic irrigation was first described by Weller et al.The files are designed to
oscillate at ultrasonic frequencies of 25-30kHz and operate in a transverse vibration,
setting up a characteristic pattern of nodes and antinodes along their length. It enhances
irrigant canal wall interaction by transmitting acoustic energy from an oscillating
instrument to the irrigant, causing acoustic microstreaming and transient cavitation.
Generally for ultrasonic activation of irrigation solution a syringe is used to inject the
irrigant into the root canal, after which the irrigant is activated passively by an
ultrasonically oscillating instrument. Nascent chlorine, which is the active component
responsible for tissue dissolving and antimicrobial action of hypochlorite, is consumed
rapidly in such a case. Further, the amount of irrigant that is activated is small, thereby,
limiting its debridement efficacy. It has, therefore, been suggested that irrigant delivery
methods that provide continuous replenishment of root canal irrigant may be more efficient.
Recently, ultrasonic devices have been introduced that provide continuous irrigant delivery
along with ultrasonic activation. In these devices irrigating solution moves into the needle
through a syringe attached to the luer-lock connection on the needle and is then activated
and delivered into the root canal. The main advantages of this technique are the continuous
replenishment of the solution and the irrigating solution is delivered from the needle in an
activated state, avoiding the need to insert the needle into the apical third of the root
canal. Studies have shown that the 1minute of continuous ultrasonic irrigation after hand or
rotary instrumentation resulted in significantly cleaner canals and isthmi in the mesial
roots of mandibular molars. Carver et al showed that the addition of 1 minute of continuous
ultrasonic irrigation significantly reduced bacterial-positive cultures. Another study
reported that while continuous ultrasonic irrigation was as effective as intermittent
ultrasonic irrigation in the placement of irrigant in the apical part of canal, it led to
improved irrigant penetration in lateral canals. In vitro studies comparing continuous
ultrasonic irrigation with syringe irrigation in the removal of debris have reported
continuous ultrasonic irrigation to be more effective in debris removal from apical third
and narrow isthmuses. Curtis et al found that continuous ultrasonic irrigation resulted in
significantly less debris present in root canals at 1 and 3 mm from the working length as
compared to conventional needle irrigation.A recent study by Layton et al reported that
continuous ultrasonic irrigation generates high fluid velocity and shear stress in apical
third resulting in enhanced reduction of strictly adherent bacterial biofilm as compared to
intermittent ultrasonic irrigation and syringe irrigation.
Whether these parameters translate into better clinical outcome remains to be seen. However,
to the best of our knowledge, there is no study assessing the effect of irrigant activation
using continuous ultrasonic device on success of endodontic treatment. This randomized
controlled trial was therefore designed to evaluate and compare the success of endodontic
treatment after the use of continuous ultrasonic irrigation and syringe irrigation.
Methodology: The research project was carried out in the Department of Conservative
Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak (Haryana).
Protocol of the study was approved by the institutional ethical committee
(PGIDS/IEC/2014/120), Rohtak, India and it followed the ethical guidelines of the Helsinki
declaration 1975, as revised in 2000. The study was conducted from May 2014 to May 2015.
The study population comprised of patients requiring endodontic treatment following the
diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular molar.
All such patients were examined for establishing their eligibility for the study.
Evaluation of Pulp Vitality Pulp vitality status was evaluated with the help of electric
pulp testing, cold testing and clinical evaluation after access opening. If the patient did
not respond to electric and thermal test, and no bleeding was observed on access cavity
preparation, the subject was included in study provided other inclusion criteria were also
met.
Radiographic examination All periapical radiographs were exposed with a 70 kVp machine
(Confident, Blue X Imaging S.r.l Via Idiomi 1/8-33 Assago, Italy) using Rinn paralleling
device (Dentsply Ltd., Weybridge, Surrey, United Kingdom); and processed manually.
Data gathering Once eligibility was confirmed, the study was explained to the patient and
written consent to participate in the study was taken. All the diagnostic, intra operative
and post operative findings were recorded on a proforma.
Randomization The patient was randomly assigned to one of the two treatment groups:
continuous ultrasonic irrigation (CUI) and syringe irrigation (SI), based on the use of
irrigation protocol utilized during chemomechanical preparation. Subjects were assigned to
either CUI or syringe irrigation group using an equal proportion allocation ratio. Envelopes
that contained concealed assignment codes were assigned sequentially to eligible patients.
Both the patient and the operator were blinded of the treatment protocol until completion of
chemomechanical preparation.
Clinical Procedure The endodontic treatment was completed in two visits. First Visit Local
anaesthesia was administered (2% lidocaine with 1:80000 epinephrine) for patient comfort.
The tooth was then isolated with rubber dam. Caries was excavated using round bur in high
speed handpiece with copious irrigation and access to the pulp chamber was made. Working
length (WL) was obtained with the help of electronic apex locator (Root ZX) using #10 and
#15 K file and was confirmed radiographically. The canals were enlarged to a size three
sizes larger than the first apical binding file at the working length with 0.02 taper ISO
stainless steel hand files, followed by step-back technique with each successively larger
file placed 0.5 mm coronal to the previous one. Canal patency was maintained by passing a
#10 stainless steel file 0.5 to 1.0 mm beyond the working length. In both the groups, the
canals were irrigated with 5 mL of 5.25% sodium hypochlorite (NaOCl) (Hyposol; Prevest
Denpro Limited, Jammu, India) solution after every change of instrument using a 27 gauge
needle. After shaping, the canals were irrigated with 5 mL 17% EDTA (Prevest Denpro Limited,
Jammu, India) for 1 minute.
Post instrumentation irrigation: In continuous ultrasonic irrigation group, Proultra
PiezoFlow (Dentsply Tulsa Dental Specialties, Tulsa,OK) was used for the activation of the
irrigating solution according to manufacturer's recommendations. The needle was operated
using Satelec P5 Piezoelectric Ultrasonic Unit (Acteon, Mount Laurel, NJ) at power setting
of 5.The stopper on the PiezoFlow needle was set 1 mm short of binding in the canals, but no
more than 75% of the WL. A syringe containing 15 mL of 5.25% NaOCl was attached to the
Piezoflow activation needle and the inactive needle was inserted in the canal till
premeasured depth, and irrigant flow was started before activation. During activation, the
needle was moved up and down passively in the canal, while maintaining the insertion depth
to the stopper setting. The irrigation was accomplished in 1 minute per canal at a flow rate
of 15 mL/min. In the syringe irrigation group, canals were flushed with 15 ml of 5.25% NaOCl
using 27 gauge syringe.
After final irrigation, the canals were dried with sterile absorbent points and filled with
calcium hydroxide paste ( Roth International Ltd, Chicago, IL) using a lentulospiral. The
tooth was then temporarily restored with Intermediate Restorative Material (Dentsply Ltd,
Weybridge, UK).
Second Visit In the second visit, patient returned with completed pain chart and handed it
back to the operator. The intracanal dressing was removed with H- files and copious
irrigation with 5.25% NaOCl. The master apical Gutta Percha cones were then verified. Canals
were obturated with the GuttaPercha and Zinc Oxide- Eugenol based sealer in lateral
condensation. After obturation, the access cavity was restored permanently.
An immediate post-operative radiograph was then taken using preset exposure parameters with
Rinn paralleling device; and processed manually.
Follow up Follow up clinical and radiographic examination were carried out every 3 months,
until 12 months after the procedure.
