Post Operative Pain, Root Canal Sealers, Sillicon Based Sealers, Resin Based Sealers
Conditions
Brief summary
The aim of this randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers.
Detailed description
The main objectives of root canal therapy are to achieve long-term comfort, function, and aesthetics for the patients and prevention of reinfection of tooth. These objectives are provided through complete cleaning, shaping, and obturation of canals of affected teeth . Some patients may report moderate-to-severe pain and/or swelling following root canal treatment . This is detrimental for both patient and dentist and may entail an unscheduled emergency visit by patients to relieve their symptoms. Postoperative pain is considered a clinical outcome that exhibits the multifactorial nature of patients' responses to variables among treatment procedures such as maintaining the working length to the apical constriction, finishing the endodontic treatment in single visit or multiple visit, instrumentation technique and the type of endodontic sealer used for obturation . Such pain occurrence is mainly due to mechanical, chemical or microbial injury to the periapical tissues . Trauma of periapical tissue or bacterial extrusion and root canal sealer specifically, extrusion of root canal sealer can disrupt periodontal tissues and cause inflammatory reactions. The intensity of this reaction depends on the composition of the sealer . Root canal sealers can play a crucial role in this regard by coming in contact with the periapical tissues through apical foramen and lateral canals causing a localized inflammation with a direct influence on the degree of inflammation based on the composition of the sealer in turn influencing postoperative pain levels . Silicone is inert and biocompatible and has been widely used in medicine as an implant material Silicone-based root-canal sealers are also available. However, there are no data on the clinical performance of this type of material in endodontic treatment .
Interventions
PROCEDUREActivation of the irrigant
Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation
PROCEDUREPrimary local anesthesia
Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
PROCEDURESupplemental local anesthesia
if needed
PROCEDURERemoval Of Caries and Access Cavity
• Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.
PROCEDURERubber dam isolation of tooth
Rubber dam isolation of tooth using certain clamps .
PROCEDUREBleeding control
bleeding is controlled by using excavator for the removing the pulp tissue . using a piece of cotton soaked with Sodium hypochlorite. using local anesthesia with vasoconstrictor if needed and if suitable for the patient.
PROCEDURECanal negotiation
Coronal patency of the coronal and the Middle part of the canal using file #10 Apical patency of the apical part of the canal using #10
PROCEDURECoronal flaring
Coronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls
PROCEDUREWorking Length Determination (W.L)
Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.
PROCEDUREGlide path
Glide path of the canal Using #10 ,15 ,20 ,25 K files till becoming Super-Loose Inside the Canal at the recorded w.l to create a path for the rotary file .
PROCEDUREIrrigation
Irrigation using 5.25% sodium hypochlorite introduced using side vented needle
PROCEDURECleaning and shaping using rotary system
Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .
PROCEDURESecond w.l determination
Second w.l determination using electronic apex locator before using final finishing rotary file .
PROCEDUREApical gauging
Establish the depth of apical constriction - this is the zero reading on your apex locator. your working length will be 0.5mm - 1mm short of this. After cleaning and preparing the canal system to your working length, passively insert 02 taper hand files, starting from #15. If the file goes past the apical constriction (your working length + 0.5-1mm), then choose the next largest file and repeat. When a file passively binds short of the apical constriction, that will be the upper limit of the apical constriction diameter. The smaller file before that would be the lower limit. Apical gauging helps with: Choosing the best master cone that closely matches canal length and taper Achieving true tug back - as opposed to false tug back! Minimising gutta percha extrusions during obturation
PROCEDUREMaster cone check
Master cone check Clinically and confirmatory radiograph
DRUGapplication of resin based sealer inside the canal in the resin based sealer group
application done by inserting inside the canal by spreader or master cone
DIAGNOSTIC_TESTapplication of the sillicon based sealer inside the canal in the sillicon based group
application done by injection inside the canal
PROCEDUREObturation
done by lateral condensation technique
DIAGNOSTIC_TESTVisual Analogue Scale (VAS)
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means no pain and the on the right end of the scale (10 cm) worst pain
Sponsors
British University In Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* • Patient's age ranges from 18-50 years old. * Patients with teeth diagnosed with symptomatic irreversible pulpitis. * Normal periapical condition confirmed by normal periapical radiograph * The teeth are restorable * Teeth are periodontally free, with no mobility and negative to percussion and palpation test.
Exclusion criteria
* • Teeth with immature roots * Non restorable teeth * Medically compromised patients with systemic complication that would alter the treatment. * Necrotic teeth * Teeth with apical periodontitis or periapical lesions * necrotic Teeth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | after 6 hours of endodontic treatment | Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means no pain and the on the right end of the scale (10 cm) worst pain Each Outcome Measure should typically only specify a single time point of assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| sealer extrusion | average 1 week | The 2 blinded and calibrated examiners will evaluate the immediate periapical radiographs after canal obturation. Sealer extrusion will classified to either absent or present. If there will be a sealer extrusion in at least 1 root for multirooted teeth, will be regarded as the presence of sealer extrusion Measured by clinical symptoms and signs ( pain , swelling , parasthesia ) |
| root-filling voids | after obturation is done intra-appointment | The 2 blinded and calibrated examiners will evaluate the immediate periapical radiographs after canal obturation. will classified to either absent or present. If there will be root-filling voids in at least 1 root for multirooted teeth, will be regarded as the presence of it |
| the level of root filling | after obturation is done intra-appointment | The 2 blinded and calibrated examiners will evaluate the immediate periapical radiographs after canal obturation. just discovered it will be corrected |
Countries
Egypt
Contacts
Primary ContactKareem Mohammed Elhoseny, ORCID:0009-0001-6101-5615, Bachelor
Backup ContactEngy Medhat Kataia, professor at BUE
Outcome results
None listed