Postoperative Pain After Activation of Irrigant

NCT ID: NCT06528574

Last Updated: 2024-07-30

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-04-30

Brief Summary

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The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.

PICOTS Question:

Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain

By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.

pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.

Detailed Description

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Conditions

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Pain

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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Conventional root canal treatment

Irrigation will be performed with side vented needles only

Group Type ACTIVE_COMPARATOR

Conventional root canal treatment

Intervention Type DEVICE

Root canals will be irrigated by only side perforated needle

Irrigant activation with Ultrasonic

Final irrigant activation will be done by ultrasonic

Group Type EXPERIMENTAL

Ultrasonic

Intervention Type DEVICE

Root canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system

Irrigant activation with negative pressure

Final irrigant activation will be performed with apical negative pressure

Group Type EXPERIMENTAL

Apical negative pressure

Intervention Type DEVICE

Root canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system

Irrigant activation with both Ultrasonic and negative pressure

Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device.

Group Type EXPERIMENTAL

Combined Ultrasonic and negative pressure

Intervention Type DEVICE

Root canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures.

Interventions

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Conventional root canal treatment

Root canals will be irrigated by only side perforated needle

Intervention Type DEVICE

Ultrasonic

Root canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system

Intervention Type DEVICE

Apical negative pressure

Root canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system

Intervention Type DEVICE

Combined Ultrasonic and negative pressure

Root canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Males and females Age :20-50 Mandibular mature first molars with symptomatic acute pulpitis Medically free patients

Exclusion Criteria

Pulp necrosis or apical periodontitis Periodontal disease Vertical root fracture Radiographic apical radiolucency

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Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cleveland Dental Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed A Hashem, PhD

Role: STUDY_CHAIR

Cleveland Dental Institute

Locations

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Cleveland Dental Institute

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ahmed A Hashem, PhD

Role: CONTACT

4405021591

Waleed Elmallah, PhD

Role: CONTACT

2163336695

Facility Contacts

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Ahmed A Hashem, PhD

Role: primary

440-502-1591

Waleed Elmallah

Role: backup

2163336695

Other Identifiers

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CDIENDO0001

Identifier Type: -

Identifier Source: org_study_id

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