Recruiting

GentleWave & EdgePro

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06554366

Conditions

Pulp Necroses

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GentleWave

EdgePro laser irrigation

Irrisafe passive ultrasonic irrigation

Study Details

Brief summary:

The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.

Conditions

Pulp Necroses

Study ID

NCT06554366

Start date

Aug 30, 2024

Status verified date

Aug, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Permanent teeth that are diagnosed with pulp necrosis.
  • elected to have a permanent tooth nonsurgical root canal treatment
  • Signed informed consent.

Exclusion Criteria:

  • Teeth with root fractures or previously root canal treated teeth.
  • Teeth with severe loss of structure
  • Teeth with vital pulps.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GentleWave

experimental: EdgePro

active comparator: Irrisafe passive ultrasonic irrigation

Interventions

GentleWave

Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the GentleWave procedure will be performed

EdgePro laser irrigation

Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the EdgePro procedure will be performed

Irrisafe passive ultrasonic irrigation

Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the passive ultrasonic irrigation procedure will be performed

Primary outcome measure

  • Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS) [ Time Frame: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline) ]

Central Contacts and Locations

Central contacts

David Jaramillo, DDS

(713) 486-4224David.E.Jaramillo@uth.tmc.edu

Ahmed Shehab-Eldin

(713) 486-4224Ahmed.ShehabEldin@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

David Jaramillo, DDS

(713) 486-4224David.E.Jaramillo@uth.tmc.edu

Ahmed Shehab-Eldin

9177530852Ahmed.ShehabEldin@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Keywords

  • Root canal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-09-05.