NCT06528574

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

July 18, 2024

Last Update Submit

July 26, 2024

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Numerical Pain Scale (NRS)

    Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one.

    Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.

Secondary Outcomes (1)

  • Analgesics intake

    6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.

Study Arms (4)

Conventional root canal treatment

ACTIVE COMPARATOR

Irrigation will be performed with side vented needles only

Device: Conventional root canal treatment

Irrigant activation with Ultrasonic

EXPERIMENTAL

Final irrigant activation will be done by ultrasonic

Device: Ultrasonic

Irrigant activation with negative pressure

EXPERIMENTAL

Final irrigant activation will be performed with apical negative pressure

Device: Apical negative pressure

Irrigant activation with both Ultrasonic and negative pressure

EXPERIMENTAL

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

Device: Combined Ultrasonic and negative pressure

Interventions

Conventional root canal treatmentDEVICE

Root canals will be irrigated by only side perforated needle

Conventional root canal treatment
UltrasonicDEVICE

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

Irrigant activation with Ultrasonic
Apical negative pressureDEVICE

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

Irrigant activation with negative pressure
Combined Ultrasonic and negative pressureDEVICE

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

Irrigant activation with both Ultrasonic and negative pressure

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Dental Institute

Cleveland, Ohio, 44128, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ahmed A Hashem, PhD

    Cleveland Dental Institute

    STUDY CHAIR

Central Study Contacts

Ahmed A Hashem, PhD

CONTACT

4405021591a.hashem@cdiohio.org

Waleed Elmallah, PhD

CONTACT

2163336695w.elmallah@cdiohio.org

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
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 30, 2024

Study Start

August 1, 2023

Primary Completion

December 31, 2024

Study Completion

April 30, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)