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

Not Applicable

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Other: ultrasonic activation of bioceramic sealer

• Registration Number: NCT05289791
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-21
• Study Start: 2022-04-08
• Primary Completion: 2023-04-12
• Study Completion: 2023-05-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bioceramic sealer	ultrasonic activation of bioceramic sealer	bioceramic sealer
ultrasonic activation of bioceramic sealer	ultrasonic activation of bioceramic sealer	ultrasonic activation of bioceramic sealer for 20 seconds

Primary Outcome Measures

Name	Time	Method
postoperative pain	48 hours	intensity of pain on modified Visual analogue scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Giza, Manial, Egypt