The Effect of Eddy Sonic Versus AF Max Activation of Bio-ceramic Sealer on Post-operative Pain in Teeth with Symptomatic Irreversible Pulpitis with Apical Periodontitis

The aim of endodontic therapy for an inflamed tooth is to eliminate the source of inflammation. Relieving pain depends on the effectiveness of root canal therapy.3

Postoperative pain in endodontic treatments, affecting 3-58% of patients, is often caused by peri-radicular tissue injuries. Understanding these factors helps professionals select methods and supplies to minimize discomfort.

30 patients will be divided into 3 groups according to the method of activation (10 par ticipants/each). participants will be recruited from the postgrad clinic of the endodontic department faculty of oral and dental medicine, Future University in Egypt Patients with mature mandibular first permanent molar with irreversible pulpitis with apical periodontitis Intervention 1: bio-ceramic sealer activation with Eddy sonic Intervention 2: bio-ceramic sealer activation with AF max Control/Comparator: bio-ceramic sealer without activation The study aims to evaluate the effect of Eddy Sonic and AF max activation of bio-ceramic sealer on postoperative pain in mandibular first molars with symptomatic irreversible pulpitis with apical periodontitis

Study Overview

• Status: Recruiting
• Conditions: Irreversible Pulpitis with Apical Periodontitis
• Intervention / Treatment: Device: sealer activation with Eddy sonic and AF max; Other: without AF max or Eddy sonic sealer activation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 11835
      • Recruiting
      • Future University in Egypt
      • Contact: Youssef AbdElHamed Mohamed, researcher; Phone Number: +20 01006812744; Email: youssefelansary911@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age range is from 18 to 40 years old.
• No sex predilection
• Patients seeking root canal treatment.
• restorable teeth.
• Positive patient acceptance for participating in the study.
• patients able to sign informed consent.
• Systematically healthy patient (ASA I, Il).
• Patient who can understand the numerical rate scale and sign an informed consent.
• Mandibular first molar teeth with pain on bite or percussion
• Preoperative sharp (moderate or severe) pain.
• Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
• widening in periodontal membrane space in radiographic appearance.

Exclusion Criteria:

• Patients with American Association of Anesthesiologists (ASA) classifications other than ASA 1 & Il
• Patients who have already ingested preoperative medication, such as analgesics, non-steroidal, or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
• This was done to prevent any misinterpretation of the diagnosis or post-treatment pain severity, as these drugs substantially lower post-endodontic pain (Jorge-Arajo et al.,2018).
• Patients with NSAID allergy.
• Patients having two or more adjacent teeth needing root canal therapy
• Pregnant patients.
• Patients with bleeding disorder.
• Patients with long-term corticosteroid use.

• Teeth having:

  • Necrotic pulp.
  • History or presence of swelling or fistulous tract.
  • Acute/chronic periapical abscess.
  • Mobility more than grade 1.
  • Pocket depth of more than 5mm
  • No possible restorability.
  • Previous root canal treatment.
  • Periapical radiolucency.
  • External or internal resorption
  • Vertical root fracture.
• TMJ problems, bruxism, clenching or traumatic occlusion.
• Inability to understand and perform the given instructions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bio-ceramic sealer activation with Eddy sonic before obturation; cleaning and shaping the root canals and Well Root bio ceramic sealer activation using Eddy sonic before obturation	Device: sealer activation with Eddy sonic and AF max; activation of sealer after cleaning and shaping, before the obturation
Active Comparator: bio-ceramic sealer activation with AF max before obturation; cleaning and shaping the root canals and Well Root bio ceramic sealer activation using AF max before obturation	Device: sealer activation with Eddy sonic and AF max; activation of sealer after cleaning and shaping, before the obturation
Active Comparator: bio-ceramic sealer obturation without any activation (negative control); obturation of root canals with bio ceramic sealer directly without any activation	Other: without AF max or Eddy sonic sealer activation; sealer without activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative pain after root canal treatment with sealer activation by AF max and Eddy sonic activation in comparison to without sealer activation	measuring post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).	Immediately after obturation 6-12-24 and 48 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of analgesic tablets taken after endodontic treatment	measuring number of analgesic tablets taken after endodontic treatment by counting	Up to 48 hours post-operative pain

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic presence or absence of sealer extrusion	detecting lateral and periapical sealer extrusion through postoperative periapical radiograph	Immediately after obturation

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Pulpitis; Periapical Periodontitis
• Other Study ID Numbers: FUE-REC code (17)/7/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No