Recruiting

Observational Study

Sponsor:

Cleveland Dental Institute

Code:

NCT06528574

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Conventional root canal treatment

Ultrasonic

Apical negative pressure

Combined Ultrasonic and negative pressure

Study Details

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.

Conditions

Pain

Study ID

NCT06528574

Start date

Aug 1, 2023

Status verified date

Jul, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

-

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Conventional root canal treatment

Root canals will be irrigated by only side perforated needle

Ultrasonic

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

Apical negative pressure

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

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.

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 and Locations

Central contacts

Ahmed A Hashem, PhD

4405021591a.hashem@cdiohio.org

Waleed Elmallah, PhD

2163336695w.elmallah@cdiohio.org

Locations

Cleveland Dental Institute

Recruiting

Cleveland, Ohio, United States, 44128

Contacts

Ahmed A Hashem, PhD

440-502-1591a.hashem@cdiohio.org

Waleed Elmallah

2163336695w.elmallah@cdiohio.org

More Information

Sponsor

Cleveland Dental Institute

Last update posted

Jul 30, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cleveland Dental Institute on 2024-07-30.