The Incidence of Postoperative Pain After Using Different Types of Sealers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBritish University In Egypt
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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
Disqualifiers
• Teeth with immature roots
Non restorable teeth
Medically compromised patients with systemic complication that would alter the treatment.
Necrotic teeth
Trial design
Design model
Parallel
Treatments tested in this trial
Primary local anesthesia
Procedure/SurgeryTooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
Supplemental local anesthesia
Procedure/Surgeryif needed
Removal Of Caries and Access Cavity
Procedure/Surgery• Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.
Rubber dam isolation of tooth
Procedure/SurgeryRubber dam isolation of tooth using certain clamps .
Bleeding control
Procedure/Surgerybleeding 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.
Canal negotiation
Procedure/SurgeryCoronal 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
Coronal flaring
Procedure/SurgeryCoronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls
Working Length Determination (W.L)
Procedure/SurgeryWorking length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.
Glide path
Procedure/SurgeryGlide 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 .
Irrigation
Procedure/SurgeryIrrigation using 5.25% sodium hypochlorite introduced using side vented needle
Cleaning and shaping using rotary system
Procedure/SurgeryCleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .
Second w.l determination
Procedure/SurgerySecond w.l determination using electronic apex locator before using final finishing rotary file .
Apical gauging
Procedure/SurgeryEstablish 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
Activation of the irrigant
Procedure/SurgeryActivation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation
Master cone check
Procedure/SurgeryMaster cone check Clinically and confirmatory radiograph
application of resin based sealer inside the canal in the resin based sealer group
Drugapplication done by inserting inside the canal by spreader or master cone
application of the sillicon based sealer inside the canal in the sillicon based group
Diagnostic testapplication done by injection inside the canal
Obturation
Procedure/Surgerydone by lateral condensation technique
Visual Analogue Scale (VAS)
Diagnostic testPain 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"
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group (1) Resin Based Sealer interventionExperimental treatment 19 interventions
Group B: Group (2) Silicone Based Sealer interventionExperimental treatment 19 interventions
Trial outcomes
Primary outcomes
1
Postoperative pain
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
Time frame
after 6 hours of endodontic treatment2
Postoperative pain
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"
Time frame
after 12 hours of endodontic treatment3
Postoperative pain
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"
Time frame
after 24 hours of endodontic treatment4
Postoperative pain
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"
Time frame
after 48 hours of endodontic treatmentOther outcomes
1
sealer extrusion
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 )
Time frame
average 1 week2
root-filling voids
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
Time frame
after obturation is done intra-appointment3
the level of root filling
The 2 blinded and calibrated examiners will evaluate the immediate periapical radiographs after canal obturation. just discovered it will be corrected
Time frame
after obturation is done intra-appointmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov