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Clinical Trials/NCT06640218
NCT06640218
Recruiting
Not Applicable

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

Future University in Egypt1 site in 1 country30 target enrollmentStarted: November 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
post-operative pain after root canal treatment with sealer activation by AF max and Eddy sonic activation in comparison to without sealer activation

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

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.

Outcomes

Primary Outcomes

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

  • Number of analgesic tablets taken after endodontic treatment(Up to 48 hours post-operative pain)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Youssef Abd El Hameed Mohamed Ahmed

Principal Investigator

Future University in Egypt

Study Sites (1)

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