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

NCT06640218 | Recruiting

• 1 other identifier: FUE-REC code (17)/7/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Irreversible Pulpitis with Apical Periodontitis

Outcome Measures

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).

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

Secondary Outcomes (1)

• Number of analgesic tablets taken after endodontic treatment

  Up to 48 hours post-operative pain

Other Outcomes (1)

• radiographic presence or absence of sealer extrusion

  Immediately after obturation

Study Arms (3)

bio-ceramic sealer activation with Eddy sonic before obturation

ACTIVE COMPARATOR

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

bio-ceramic sealer activation with AF max before obturation

ACTIVE COMPARATOR

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

bio-ceramic sealer obturation without any activation (negative control)

ACTIVE COMPARATOR

obturation of root canals with bio ceramic sealer directly without any activation

Other: without AF max or Eddy sonic sealer activation

Interventions

sealer activation with Eddy sonic and AF max DEVICE

activation of sealer after cleaning and shaping, before the obturation

bio-ceramic sealer activation with AF max before obturation; bio-ceramic sealer activation with Eddy sonic before obturation

without AF max or Eddy sonic sealer activation OTHER

sealer without activation

bio-ceramic sealer obturation without any activation (negative control)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

EG (1)