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Dental Pulp NecrosesNCT06569329

Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals

A study testing GentleWave System Root Canal Therapy, EdgePro Laser Root Canal Therapy and The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy in people with Dental Pulp Necroses, run by Abhishek Parolia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Dental Pulp Necroses
What is being tested?
GentleWave System Root Canal Therapy, EdgePro Laser Root Canal Therapy and The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
20 Aug 2024to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abhishek Parolia, PhD, MDS contact

(319) 335-7471

abhishek-parolia@uiowa.edu

United States1 site, 1 recruiting
  • University of Iowa College of Dentistry and Dental Clinics

    Iowa City, Iowa, 52242

    Abhishek Parolia, DDS, PhD, (319) 335-7471, abhishek-parolia@uiowa.edu

    Recruiting

Other trials in United States

About this study

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

Read the detailed description

Sample Size Calculation Sample size was calculated by STATISTICA v8.0 software (StatSoft, Tulsa, OK, USA), that demonstrated 23 teeth per group are needed to show a 5% difference in bacterial levels at 90% power. Considering possible losses, ninety adult subjects will be selected.

Case Selection and Eligibility Criteria Participants will be recruited at the Endodontic Clinic at the University of Iowa. The inclusion criteria will be patients 18 years or older, teeth with intact pulp chamber walls, no response to cold and electric pulp testing and apical periodontitis.

Teeth with vital pulp, incomplete root formation, extensive crown destruction, previous endodontic treatment or intervention (pulp debridement), acute/ chronic apical abscess, internal or external resorption, non-odontogenic facial pain, periodontal probing deeper than 4 mm, advanced untreated periodontal disease or recent periodontal surgery, teeth with mobility score > 2, fracture or visible crack, patients with diabetes or immune-compromised conditions, patients who received systemic antibiotics within the last three months, or taking corticosteroids, and pregnancy will be excluded.

Study Intervention Root canal samples will be taken under strict asepsis, as described by Rodrigues et al. (21). Operative field will be disinfected using 3% hydrogen peroxide and 3% NaOCl under rubber dam isolation. Once the access cavity is prepared, 10% sodium thiosulfate solution will be injected into the pulp chamber, and the sterility control (SC) will be taken from the access cavity walls' internal surfaces using sterile paper points. This sample will be transferred aseptically to a cryotube containing RNA later (Ambion, Austin, TX) and stored at -20°C.

The first sample (S1) will be taken as the baseline quantity of bacteria before chemomechanical preparation. One ml of 10% sodium thiosulfate solution will be injected into the canal, and a sterile paper point will be introduced up to that length for 1 minute, transferred in cryotubes containing RNA later, and stored at -20°C.

The root canal will be shaped and cleaned using rotary endodontic instruments up to size 35/.04, with periodic irrigation with 5 mL of 3% NaOCl between each instrumentation. After apical preparation, the canal will be dried with sterile paper points and then washed with 1 mL of 10% sodium thiosulfate for 1 minute to inactivate NaOCl. After that, a second sample (S2) will be collected and stored as described for S1.

Teeth specimens will be randomly assigned to three groups (n=30) according to the type of supplementary disinfection approaches used: (1) GWS, (2) LAI, and (3) UAI. These devices will be used as stated above in phase 1 of this study. After using supplementary disinfection approaches, a third sample (S3) will be collected from the root canal and stored as described above for S1 and S2.

Being tested
GentleWave System Root Canal Therapy, EdgePro Laser Root Canal Therapy, The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy
Medical subject headings
Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GentleWave System Root Canal TherapyDevice

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

  • EdgePro Laser Root Canal TherapyDevice

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

  • The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal TherapyDevice

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

Study groups in NCT06569329
Study groupRoleWhat they receive
GentleWave System Root Canal TherapyExperimentalSterile 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.
Receives: Device: GentleWave System Root Canal Therapy
EdgePro Laser Root Canal TherapyExperimentalSterile 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.
Receives: Device: EdgePro Laser Root Canal Therapy
The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal TherapyExperimentalSterile 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.
Receives: Device: The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start20 Aug 2024
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569329
Sponsor's protocol ID
202402221
Status last verified
Sep 2026
First submitted
19 Aug 2024
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GentleWave System Root Canal Therapy, EdgePro Laser Root Canal Therapy and The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy in people with Dental Pulp Necroses, run by Abhishek Parolia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abhishek Parolia, PhD, MDS ((319) 335-7471, abhishek-parolia@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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