The Incidence of Postoperative Pain After Using Different Types of Sealers

July 5, 2024 updated by: Kareem darwish, British University In Egypt

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kareem Mohammed Elhoseny, ORCID:0009-0001-6101-5615, Bachelor
  • Phone Number: 01157215056
  • Email: Kareem.Darwish@bue.edu.eg

Study Locations

  • Egypt
    • Cairo
      • El Shorouk, Cairo, Egypt, +20 19283
        • Recruiting
        • British University In Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (1) Resin Based Sealer intervention
evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Procedure: Primary local anesthesia
Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
Procedure: Supplemental local anesthesia
if needed
Other Names:
  • intraligamentary injection / Intrapulpal Anesthesia
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
Other Names:
  • Coronal patency
  • Apical patency
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
Other Names:
  • AH plus
Diagnostic test: application of the sillicon based sealer inside the canal in the sillicon based group
application done by injection inside the canal
Other Names:
  • Gutta flow 2
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"
Experimental: Group (2) Silicone Based Sealer intervention
evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Procedure: Primary local anesthesia
Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
Procedure: Supplemental local anesthesia
if needed
Other Names:
  • intraligamentary injection / Intrapulpal Anesthesia
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
Other Names:
  • Coronal patency
  • Apical patency
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
Other Names:
  • AH plus
Diagnostic test: application of the sillicon based sealer inside the canal in the sillicon based group
application done by injection inside the canal
Other Names:
  • Gutta flow 2
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 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
after 6 hours of endodontic treatment
Postoperative pain
Time Frame: after 12 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"
after 12 hours of endodontic treatment
Postoperative pain
Time Frame: after 24 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"
after 24 hours of endodontic treatment
Postoperative pain
Time Frame: after 48 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"
after 48 hours of endodontic treatment
Postoperative pain
Time Frame: after 72 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"
after 72 hours of endodontic treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
sealer extrusion
Time Frame: 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 )
average 1 week
root-filling voids
Time Frame: 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
after obturation is done intra-appointment
the level of root filling
Time Frame: 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
after obturation is done intra-appointment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British University In Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

April 22, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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