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CompletedNCT05289791Updated Nov 8, 2023

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

An interventional study of ultrasonic activation of bioceramic sealer in Symptomatic Irreversible Pulpitis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Symptomatic Irreversible Pulpitis

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03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 32 is below the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    ultrasonic activation of bioceramic sealer

    ultrasonic activation of bioceramic sealer for 20 seconds

    Other: ultrasonic activation of bioceramic sealer

  • Active comparator
    bioceramic sealer

    bioceramic sealer

    Other: ultrasonic activation of bioceramic sealer

Interventions

  • Otherultrasonic activation of bioceramic sealer

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

06

What researchers measure

Primary outcomes

  1. postoperative pain

    intensity of pain on modified Visual analogue scale

    Time frame: 6 hours

  2. postoperative pain

    intensity of pain on modified Visual analogue scale

    Time frame: 12 hours

  3. postoperative pain

    intensity of pain on modified Visual analogue scale

    Time frame: 24 hours

  4. postoperative pain

    intensity of pain on modified Visual analogue scale

    Time frame: 48 hours

Secondary outcomes

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

    number of analgesics taken by patient in 1st 48 hours

    Time frame: up to 48 hours postoperatively

  2. Sealer Extrusion laterally and periapically

    presence or absence of sealer extrusion

    Time frame: Immediately after obturation.

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Study locations

1 site
  • Cairo university
    Giza, Manial, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05289791
Lead sponsor
Cairo University
Responsible party
Bassant Yasser Shaker Ibrahim El-Saharty (principal investigator, Cairo University) — Principal investigator
First posted
Mar 21, 2022
Start date
Apr 8, 2022
Primary completion
Apr 12, 2023
Completion
May 2, 2023
Last update
Nov 8, 2023

Study contacts

Heba M. El-far, professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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