Postoperative Pain After Activation of Irrigant

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Cleveland Dental Institute
Study ID
NCT06528574
Status
Recruiting
Apply to this trial

Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Conventional root canal treatment — DEVICE
    Root canals will be irrigated by only side perforated needle
  • Ultrasonic — DEVICE
    Root canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system
  • Apical negative pressure — DEVICE
    Root canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system
  • Combined Ultrasonic and negative pressure — 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Apr 30, 2025

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional root canal treatment
    Irrigation will be performed with side vented needles only
  • Experimental: Irrigant activation with Ultrasonic
    Final irrigant activation will be done by ultrasonic
  • Experimental: Irrigant activation with negative pressure
    Final irrigant activation will be performed with apical negative pressure
  • Experimental: Irrigant activation with both Ultrasonic and negative pressure
    Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device.

Primary Outcome Measure

Numerical Pain Scale (NRS) [ Time Frame: Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Dental InstituteClevelandOhio44128
Ahmed A Hashem, PhD
[email protected]
440-502-1591
Waleed Elmallah
[email protected]
2163336695

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