Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals

NCT06569329 | Recruiting DMC FDA Device

• 1 other identifier: 202402221
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the effect that 3 different types of root canal procedures have on bacteria.

Conditions

Dental Pulp Necroses

Outcome Measures

Primary Outcomes (1)

• Assessment of the changes in the bacterial count at various time points during the root canal procedure.

  Sterile paper points will be inserted into the root canal in order to collect bacteria. Real-time Polymerase Chain Reaction will be used to assess the bacterial counts.

  Baseline (pre-intervention) and during the intervention and immediately after the intervention

Study Arms (3)

GentleWave System Root Canal Therapy

EXPERIMENTAL

Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the GentleWave System root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

Device: GentleWave System Root Canal Therapy

EdgePro Laser Root Canal Therapy

EXPERIMENTAL

Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the EdgePro Laser root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

Device: EdgePro Laser Root Canal Therapy

The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

EXPERIMENTAL

Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the ProUltra Piezo Ultrasonic with EndoUltra Tips root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

Device: The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

Interventions

GentleWave System Root Canal Therapy DEVICE

This device has 510k market approval for its intended use within this study.

GentleWave System Root Canal Therapy

EdgePro Laser Root Canal Therapy DEVICE

This device has 510k market approval for its intended use within this study.

EdgePro Laser Root Canal Therapy

The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy DEVICE

This device has 510k market approval for its intended use within this study.

The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of pulp necrosis with apical periodontitis (AP) confirmed by pulp tests, clinical and radiographic evidence.
• Tooth with no response to cold and electric pulp testing (done at screening).
• Single canalled premolars with intact pulp chamber walls.
• Patient must be 18 years of age or older

You may not qualify if:

• Teeth with vital pulp.
• Teeth with incomplete root formation (immature with apical periodontitis).
• Teeth with extensive crown destruction.
• Teeth with previous endodontic treatment or intervention (pulp debridement).
• Teeth with acute/ chronic apical abscess.
• Teeth with internal or external resorption.
• Teeth with non-odontogenic facial pain.
• Teeth with periodontal pockets deeper than 4 mm.
• Teeth with advanced untreated periodontal disease or recent periodontal surgery.
• Teeth with mobility score greater than 2.
• Teeth with a fracture or visible crack.
• Patients with diabetes or immune compromised conditions.
• Patients who received systemic antibiotics within the last 3 months.
• Patients taking corticosteroids.
• Patients who are pregnant.

Sponsors & Collaborators

• Abhishek Parolia: lead

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abhishek Parolia, PhD, MDS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhishek Parolia, PhD, MDS

CONTACT

(319) 335-7471; abhishek-parolia@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)