Recruiting

Supplementary Disinfection

Sponsor:

Abhishek Parolia

Code:

NCT06569329

Conditions

Dental Pulp Necroses

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

GentleWave System Root Canal Therapy

EdgePro Laser Root Canal Therapy

The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

Study Details

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

Study ID

NCT06569329

Start date

Aug 20, 2024

Status verified date

Aug, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: GentleWave System Root Canal Therapy

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.

experimental: EdgePro Laser Root Canal Therapy

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.

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

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.

Interventions

GentleWave System Root Canal Therapy

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

EdgePro Laser Root Canal Therapy

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

The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

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

Primary outcome measure

  • Assessment of the changes in the bacterial count at various time points during the root canal procedure. [ Time Frame: Baseline (pre-intervention) and during the intervention and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Abhishek Parolia, PhD, MDS

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

Locations

University of Iowa College of Dentistry and Dental Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Abhishek Parolia, DDS, PhD

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

More Information

Sponsor

Abhishek Parolia

Last update posted

Sep 17, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abhishek Parolia on 2025-09-17.