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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorFuture University in Egypt

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age range is from 18 to 40 years old.

No sex predilection

Patients seeking root canal treatment.

restorable teeth.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    sealer without activation

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: bio-ceramic sealer activation with Eddy sonic before obturationActive comparator 1 intervention
Group B: bio-ceramic sealer activation with AF max before obturationActive comparator 1 intervention
Group C: bio-ceramic sealer obturation without any activation (negative control)Active comparator 1 intervention

Trial outcomes

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

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).

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

Secondary outcomes

1

Number of analgesic tablets taken after endodontic treatment

measuring number of analgesic tablets taken after endodontic treatment by counting

Time frame
Up to 48 hours post-operative pain

Other outcomes

1

radiographic presence or absence of sealer extrusion

detecting lateral and periapical sealer extrusion through postoperative periapical radiograph

Time frame
Immediately after obturation

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