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

NCT ID: NCT06640218

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-04-01

Brief Summary

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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

Detailed Description

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Conditions

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Irreversible Pulpitis with Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

sealer activation with Eddy sonic and AF max

Intervention Type DEVICE

activation of sealer after cleaning and shaping, before the obturation

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

Group Type ACTIVE_COMPARATOR

sealer activation with Eddy sonic and AF max

Intervention Type DEVICE

activation of sealer after cleaning and shaping, before the obturation

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

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

Group Type ACTIVE_COMPARATOR

without AF max or Eddy sonic sealer activation

Intervention Type OTHER

sealer without activation

Interventions

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sealer activation with Eddy sonic and AF max

activation of sealer after cleaning and shaping, before the obturation

Intervention Type DEVICE

without AF max or Eddy sonic sealer activation

sealer without activation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Youssef Abd El Hameed Mohamed Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Future University in Egypt

Cairo, New Cairo, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Youssef AbdElHamed Mohamed, researcher

Role: primary

01006812744 ext. +20

Other Identifiers

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FUE-REC code (17)/7/2024

Identifier Type: -

Identifier Source: org_study_id

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