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

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289791
• Other study ID #: ENDO 3-3-5
• Status: Completed
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university	Giza	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	intensity of pain on modified Visual analogue scale	6 hours
Primary	postoperative pain	intensity of pain on modified Visual analogue scale	12 hours
Primary	postoperative pain	intensity of pain on modified Visual analogue scale	24 hours
Primary	postoperative pain	intensity of pain on modified Visual analogue scale	48 hours
Secondary	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
Secondary	Sealer Extrusion laterally and periapically	presence or absence of sealer extrusion	Immediately after obturation.