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NCT Number: NCT06640218

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Location status: Recruiting

Location contact

Youssef AbdElHamed Mohamed, researcher

CONTACT

[email protected]

01006812744 ext. +20

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sealer activation with Eddy sonic and AF max

Device

activation of sealer after cleaning and shaping, before the obturation

without AF max or Eddy sonic sealer activation

Other

sealer without activation

Primary outcomes

  1. post-operative pain after root canal treatment with sealer activation by AF max and Eddy sonic activation in comparison to without sealer activation

    Time frame: Immediately after obturation 6-12-24 and 48 hours post-operative

    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).

Secondary outcomes

  1. Number of analgesic tablets taken after endodontic treatment

    Time frame: Up to 48 hours post-operative pain

    measuring number of analgesic tablets taken after endodontic treatment by counting

Other outcomes

  1. radiographic presence or absence of sealer extrusion

    Time frame: Immediately after obturation

    detecting lateral and periapical sealer extrusion through postoperative periapical radiograph

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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