Clinical trial

The Incidence of Postoperative Pain After Using Different Types of Sealers (A Randomized Clinical Trial)

Name
22-017
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-10-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Primary local anesthesia
Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Supplemental local anesthesia
if needed
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Other names:
intraligamentary injection / Intrapulpal Anesthesia
Removal Of Caries and Access Cavity
• Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Rubber dam isolation of tooth
Rubber dam isolation of tooth using certain clamps .
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Bleeding 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.
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Canal 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
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Other names:
Coronal patency, Apical patency
Coronal flaring
Coronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Working Length Determination (W.L)
Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Glide 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 .
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Irrigation
Irrigation using 5.25% sodium hypochlorite introduced using side vented needle
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Cleaning and shaping using rotary system
Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Second w.l determination
Second w.l determination using electronic apex locator before using final finishing rotary file .
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Apical 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
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Activation of the irrigant
Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Master cone check
Master cone check Clinically and confirmatory radiograph
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
application 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
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Other names:
AH plus
application of the sillicon based sealer inside the canal in the sillicon based group
application done by injection inside the canal
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Other names:
Gutta flow 2
Obturation
done by lateral condensation technique
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Visual 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"
Arms:
Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention
Size
50
Primary endpoint
Postoperative pain
after 6 hours of endodontic treatment
Postoperative pain
after 12 hours of endodontic treatment
Postoperative pain
after 24 hours of endodontic treatment
Postoperative pain
after 48 hours of endodontic treatment
Postoperative pain
after 72 hours of endodontic treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-06-11

1 organization