Skip to main content
OpenTrials
Completed

NCT Number: NCT05289791

Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars

The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Giza, Manial, Egypt

About this study

To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal bioceramic sealer for 20 seconds using non cutting ultrasonic tip.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients above 18 years old and to 50.
  • Male or female.
  • Patients seeking root canal treatment.
  • Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
  • Systematically healthy patient (ASA I, II).
  • Patient who can understand modified VAS and sign informed consent

Exclusion criteria

  • Medically compromised patients having significant systemic disorders. (ASA III or IV).
  • History of intolerance to NSAIDS.
  • Patients with two or more adjacent teeth requiring endodontic treatment.
  • External root resorption.
  • Internal root resorption.
  • Vertical root fracture.
  • Periapical lesion.
  • Association with swelling.
  • Acute peri-apical abscess or acute exacerbation of a chronic abscess.
  • Pregnancy.
  • Use of ibuprofen in the last 12 hour.
  • Bleeding disorder.
  • Long term corticosteroid use.
  • Mobility Grade II or III.
  • Pocket depth more than 5mm.
  • Previous root canal therapy.
  • Non-restorability.
  • TMJ problems, bruxism, clenching or traumatic occlusion.
  • Inability to perceive the given instructions

Treatment and study plan

ultrasonic activation of bioceramic sealer

Other

activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction

Primary outcomes

  1. postoperative pain

    Time frame: 6 hours

    intensity of pain on modified Visual analogue scale

  2. postoperative pain

    Time frame: 12 hours

    intensity of pain on modified Visual analogue scale

  3. postoperative pain

    Time frame: 24 hours

    intensity of pain on modified Visual analogue scale

  4. postoperative pain

    Time frame: 48 hours

    intensity of pain on modified Visual analogue scale

Secondary outcomes

  1. number of analgesic tablets taken by patient after endodontic treatment

    Time frame: up to 48 hours postoperatively

    number of analgesics taken by patient in 1st 48 hours

  2. Sealer Extrusion laterally and periapically

    Time frame: Immediately after obturation.

    presence or absence of sealer extrusion

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Nov 8, 2023

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.

Published trials that share one or more normalized conditions with this study.