NCT05841290

The Incidence of Postoperative Pain After Using Different Types of Sealers

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: British University In Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Post Operative Pain
• Root Canal Sealers
• Sillicon Based Sealers
• Resin Based Sealers

Interventions

Type	Name	Description
PROCEDURE	Primary local anesthesia	Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
PROCEDURE	Supplemental local anesthesia	if needed
PROCEDURE	Removal Of Caries and Access Cavity	• Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.
PROCEDURE	Rubber dam isolation of tooth	Rubber dam isolation of tooth using certain clamps .
PROCEDURE	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.
PROCEDURE	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
PROCEDURE	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
PROCEDURE	Working Length Determination (W.L)	Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.
PROCEDURE	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 .
PROCEDURE	Irrigation	Irrigation using 5.25% sodium hypochlorite introduced using side vented needle
PROCEDURE	Cleaning and shaping using rotary system	Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .
PROCEDURE	Second w.l determination	Second w.l determination using electronic apex locator before using final finishing rotary file .
PROCEDURE	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
PROCEDURE	Activation of the irrigant	Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation
PROCEDURE	Master cone check	Master cone check Clinically and confirmatory radiograph
DRUG	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
DIAGNOSTIC_TEST	application of the sillicon based sealer inside the canal in the sillicon based group	application done by injection inside the canal
PROCEDURE	Obturation	done by lateral condensation technique
DIAGNOSTIC_TEST	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"

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2023-05-03
• Last updated: 2024-07-08

Locations

1 site across 1 country: Egypt