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

NCT ID: NCT05289791

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-05-02

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.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ultrasonic activation of bioceramic sealer

ultrasonic activation of bioceramic sealer for 20 seconds

Group Type: EXPERIMENTAL

ultrasonic activation of bioceramic sealer

Intervention Type: OTHER

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

bioceramic sealer

bioceramic sealer

Group Type: ACTIVE_COMPARATOR

ultrasonic activation of bioceramic sealer

Intervention Type: OTHER

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

Interventions

ultrasonic activation of bioceramic sealer

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Bassant Yasser Shaker Ibrahim El-Saharty

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba M. El-far, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo university

Giza, Manial, Egypt

Countries

Egypt

Other Identifiers

ENDO 3-3-5

Identifier Type: -

Identifier Source: org_study_id