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

NCT05289791 | Completed

• 1 other identifier: ENDO 3-3-5
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (4)

• postoperative pain

  intensity of pain on modified Visual analogue scale

  6 hours

• postoperative pain

  intensity of pain on modified Visual analogue scale

  12 hours

• postoperative pain

  intensity of pain on modified Visual analogue scale

  24 hours

• postoperative pain

  intensity of pain on modified Visual analogue scale

  48 hours

Secondary Outcomes (2)

• number of analgesic tablets taken by patient after endodontic treatment

  up to 48 hours postoperatively

• Sealer Extrusion laterally and periapically

  Immediately after obturation.

Study Arms (2)

ultrasonic activation of bioceramic sealer

EXPERIMENTAL

ultrasonic activation of bioceramic sealer for 20 seconds

Other: ultrasonic activation of bioceramic sealer

bioceramic sealer

ACTIVE COMPARATOR

bioceramic sealer

Other: ultrasonic activation of bioceramic sealer

Interventions

ultrasonic activation of bioceramic sealer OTHER

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

bioceramic sealer; ultrasonic activation of bioceramic sealer

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, Manial, Egypt

Location

Study Officials

• Heba M. El-far, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 21, 2022
• Study Start: April 8, 2022
• Primary Completion: April 12, 2023
• Study Completion: May 2, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

EG (1)