The Incidence of Postoperative Pain After Using Different Types of Sealers

NCT05841290 | Recruiting

• 1 other identifier: 22-017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Other Outcomes (3)

• sealer extrusion

  average 1 week

• root-filling voids

  after obturation is done intra-appointment

• the level of root filling

  after obturation is done intra-appointment

Study Arms (2)

Group (1) Resin Based Sealer intervention

EXPERIMENTAL

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

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)

Group (2) Silicone Based Sealer intervention

EXPERIMENTAL

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

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)

Interventions

Primary local anesthesia PROCEDURE

Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Supplemental local anesthesia PROCEDURE

if needed

Also known as: intraligamentary injection / Intrapulpal Anesthesia

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Removal Of Caries and Access Cavity PROCEDURE

• Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Rubber dam isolation of tooth PROCEDURE

Rubber dam isolation of tooth using certain clamps .

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Bleeding control PROCEDURE

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.

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Canal negotiation PROCEDURE

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

Also known as: Coronal patency, Apical patency

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Coronal flaring PROCEDURE

Coronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Working Length Determination (W.L) PROCEDURE

Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Glide path PROCEDURE

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 .

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Irrigation PROCEDURE

Irrigation using 5.25% sodium hypochlorite introduced using side vented needle

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Cleaning and shaping using rotary system PROCEDURE

Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Second w.l determination PROCEDURE

Second w.l determination using electronic apex locator before using final finishing rotary file .

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Apical gauging PROCEDURE

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

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Activation of the irrigant PROCEDURE

Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Master cone check PROCEDURE

Master cone check Clinically and confirmatory radiograph

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 DRUG

application done by inserting inside the canal by spreader or master cone

Also known as: AH plus

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

application of the sillicon based sealer inside the canal in the sillicon based group DIAGNOSTIC_TEST

application done by injection inside the canal

Also known as: Gutta flow 2

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Obturation PROCEDURE

done by lateral condensation technique

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Visual Analogue Scale (VAS) DIAGNOSTIC_TEST

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"

Group (1) Resin Based Sealer intervention; Group (2) Silicone Based Sealer intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British University in Egypt

El Shorouk, Cairo Governorate, +20 19283, Egypt

RECRUITING

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Therapeutic Irrigation; epoxy resin-based root canal sealer; Dental Occlusion; Pain Measurement

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Kareem Mohammed Elhoseny, ORCID:0009-0001-6101-5615, Bachelor

CONTACT

01157215056; Kareem.Darwish@bue.edu.eg

Engy Medhat Kataia, professor at BUE

CONTACT

01001859898; Engy.medhat@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, Endodontics department , Faculty of dentistry brititsh university in egypt

Model Details: Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: May 3, 2023
• Study Start: August 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

EG (1)