Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars

Not Applicable

Recruiting

• Conditions: Pulp Necroses
• Interventions: Device: GentleWave; Device: Irrisafe passive ultrasonic irrigation; Device: EdgePro laser irrigation

• Registration Number: NCT06554366
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-15
• Study Start: 2024-08-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GentleWave	GentleWave	-
Irrisafe passive ultrasonic irrigation	Irrisafe passive ultrasonic irrigation	-
EdgePro	EdgePro laser irrigation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Presence of proteolytic versus non-proteolytic bacteria in the root canals	Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States