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

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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Other: ultrasonic activation of bioceramic sealer

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Giza, Manial, Egypt
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasonic activation of bioceramic sealer; ultrasonic activation of bioceramic sealer for 20 seconds	Other: ultrasonic activation of bioceramic sealer; activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction
Active Comparator: bioceramic sealer	Other: ultrasonic activation of bioceramic sealer; activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of analgesic tablets taken by patient after endodontic treatment	number of analgesics taken by patient in 1st 48 hours	up to 48 hours postoperatively
Sealer Extrusion laterally and periapically	presence or absence of sealer extrusion	Immediately after obturation.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Heba M. El-far, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis
• Other Study ID Numbers: ENDO 3-3-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No