Clinical trial NCT05841290: The Incidence of Postoperative Pain After Using Different Types of Sealers
Official title: The Incidence of Postoperative Pain After Using Different Types of Sealers (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Root Canal Sealers
Sillicon Based Sealers
Resin Based Sealers
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio
Primary purpose: SCREENING

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.

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain
timeFrame: after 6 hours of endodontic treatment
measure: Postoperative pain
timeFrame: after 12 hours of endodontic treatment
measure: Postoperative pain
timeFrame: after 24 hours of endodontic treatment
measure: Postoperative pain
timeFrame: after 48 hours of endodontic treatment
measure: Postoperative pain
timeFrame: after 72 hours of endodontic treatment
Secondary outcomes:
Other outcomes:
measure: sealer extrusion
timeFrame: average 1 week
measure: root-filling voids
timeFrame: after obturation is done intra-appointment
measure: the level of root filling
timeFrame: after obturation is done intra-appointment
Locations:
city: El Shorouk
country: Egypt
facility: British University in Egypt
state: Cairo
Study officials:
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