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NCT Number: NCT05841290

The Incidence of Postoperative Pain After Using Different Types of Sealers

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Resin Based Sealers Root Canal Sealers Signs and Symptoms Sillicon Based Sealers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British University in Egypt

El Shorouk, Cairo Governorate, +20 19283, Egypt

Location status: Recruiting

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary local anesthesia

Procedure

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

Supplemental local anesthesia

Procedure

if needed

Other names: intraligamentary injection / Intrapulpal Anesthesia

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.

Rubber dam isolation of tooth

Procedure

Rubber dam isolation of tooth using certain clamps .

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.

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

Other names: Coronal patency, Apical patency

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

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.

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 .

Irrigation

Procedure

Irrigation using 5.25% sodium hypochlorite introduced using side vented needle

Cleaning and shaping using rotary system

Procedure

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

Second w.l determination

Procedure

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

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

Activation of the irrigant

Procedure

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

Master cone check

Procedure

Master cone check Clinically and confirmatory radiograph

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

Other names: AH plus

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

Diagnostic Test

application done by injection inside the canal

Other names: Gutta flow 2

Obturation

Procedure

done by lateral condensation technique

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"

Primary outcomes

  1. 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

  2. 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"

  3. 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"

  4. 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"

  5. 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"

Other outcomes

  1. 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 )

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Engy Medhat Kataia, professor at BUE

CONTACT

[email protected]

01001859898

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

CONTACT

[email protected]

01157215056

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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