The Incidence of Postoperative Pain After Using Different Types of Sealers

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Post Operative Pain, Root Canal Sealers, Sillicon Based Sealers, Resin Based Sealers

Intervention / Treatment
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* Procedure: Primary local anesthesia
* Procedure: Supplemental local anesthesia
* Procedure: Removal Of Caries and Access Cavity
* Procedure: Rubber dam isolation of tooth
* Procedure: Bleeding control
* Procedure: Canal negotiation
* Procedure: Coronal flaring
* Procedure: Working Length Determination (W.L)
* Procedure: Glide path
* Procedure: Irrigation
* Procedure: Cleaning and shaping using rotary system
* Procedure: Second w.l determination
* Procedure: Apical gauging
* Procedure: Activation of the irrigant
* Procedure: Master cone check
* Drug: application of resin based sealer inside the canal in the resin based sealer group
* Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group
* Procedure: Obturation
* Diagnostic Test: Visual Analogue Scale (VAS)


Participation Criteria
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Eligibility Criteria
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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 Teeth that need multiple visits treatment like necrotic cases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (1) Resin Based Sealer intervention<br>evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers. | Procedure: Primary local anesthesia<br>* Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.<br>Procedure: Supplemental local anesthesia<br>* if needed<br>* Other names: intraligamentary injection / Intrapulpal Anesthesia;Procedure: Removal Of Caries and Access Cavity<br>* • Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.<br>Procedure: Rubber dam isolation of tooth<br>* Rubber dam isolation of tooth using certain clamps .<br>Procedure: Bleeding control<br>* 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.<br>Procedure: Canal negotiation<br>* 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<br>* Other names: Apical patency;Procedure: Coronal flaring<br>* Coronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls<br>Procedure: Working Length Determination (W.L)<br>* Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.<br>Procedure: Glide path<br>* 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 .<br>Procedure: Irrigation<br>* Irrigation using 5.25% sodium hypochlorite introduced using side vented needle<br>Procedure: Cleaning and shaping using rotary system<br>* Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .<br>Procedure: Second w.l determination<br>* Second w.l determination using electronic apex locator before using final finishing rotary file .<br>Procedure: Apical gauging<br>* 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<br>Procedure: Activation of the irrigant<br>* Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation<br>Procedure: Master cone check<br>* Master cone check Clinically and confirmatory radiograph<br>Drug: application of resin based sealer inside the canal in the resin based sealer group<br>* application done by inserting inside the canal by spreader or master cone<br>* Other names: AH plus;Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group<br>* application done by injection inside the canal<br>* Other names: Gutta flow 2;Procedure: Obturation<br>* done by lateral condensation technique<br>Diagnostic Test: Visual Analogue Scale (VAS)<br>* 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<br>|
| Experimental: Group (2) Silicone Based Sealer intervention<br>evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers. | Procedure: Primary local anesthesia<br>* Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.<br>Procedure: Supplemental local anesthesia<br>* if needed<br>* Other names: intraligamentary injection / Intrapulpal Anesthesia;Procedure: Removal Of Caries and Access Cavity<br>* • Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.<br>Procedure: Rubber dam isolation of tooth<br>* Rubber dam isolation of tooth using certain clamps .<br>Procedure: Bleeding control<br>* 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.<br>Procedure: Canal negotiation<br>* 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<br>* Other names: Apical patency;Procedure: Coronal flaring<br>* Coronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls<br>Procedure: Working Length Determination (W.L)<br>* Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.<br>Procedure: Glide path<br>* 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 .<br>Procedure: Irrigation<br>* Irrigation using 5.25% sodium hypochlorite introduced using side vented needle<br>Procedure: Cleaning and shaping using rotary system<br>* Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .<br>Procedure: Second w.l determination<br>* Second w.l determination using electronic apex locator before using final finishing rotary file .<br>Procedure: Apical gauging<br>* 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<br>Procedure: Activation of the irrigant<br>* Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation<br>Procedure: Master cone check<br>* Master cone check Clinically and confirmatory radiograph<br>Drug: application of resin based sealer inside the canal in the resin based sealer group<br>* application done by inserting inside the canal by spreader or master cone<br>* Other names: AH plus;Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group<br>* application done by injection inside the canal<br>* Other names: Gutta flow 2;Procedure: Obturation<br>* done by lateral condensation technique<br>Diagnostic Test: Visual Analogue Scale (VAS)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | after 6 hours of endodontic treatment | 
| 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 | after 12 hours of endodontic treatment | 
| 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 | after 24 hours of endodontic treatment | 
| 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 | after 48 hours of endodontic treatment | 
| 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 | after 72 hours of endodontic treatment |