Pulp NecrosesNCT06554366
Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars
A study testing GentleWave, EdgePro laser irrigation and Irrisafe passive ultrasonic irrigation in people with Pulp Necroses, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulp Necroses
- What is being tested?
- GentleWave, EdgePro laser irrigation and Irrisafe passive ultrasonic irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to 30 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanent teeth that are diagnosed with pulp necrosis.
- elected to have a permanent tooth nonsurgical root canal treatment
- Signed informed consent.
Who cannot join
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Teeth with vital pulps.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
David Jaramillo, DDS, (713) 486-4224, David.E.Jaramillo@uth.tmc.edu
Ahmed Shehab-Eldin, 9177530852, Ahmed.ShehabEldin@uth.tmc.edu
About this study
Official title: Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars: An In-vivo Study
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
- Being tested
- GentleWave, EdgePro laser irrigation, Irrisafe passive ultrasonic irrigation
- Keywords
- Root canal
- 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.
GentleWaveDevice
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 irrigationDevice
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 irrigationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| GentleWave | Experimental | Not described Receives: Device: GentleWave |
| EdgePro | Experimental | Not described Receives: Device: EdgePro laser irrigation |
| Irrisafe passive ultrasonic irrigation | Active comparator | Not described Receives: Device: Irrisafe passive ultrasonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS)
Measured: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Secondary outcomes (1)
Presence of proteolytic versus non-proteolytic bacteria in the root canals
Measured: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start30 Aug 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E Jaramillo, The University of Texas Health Science Center, Houston
- Investigators
- David Jaramillo, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554366
- Sponsor's protocol ID
- HSC-DB-24-0062
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars: An In-vivo Study
- ClinicalTrials.gov ID
- NCT06554366
- Acronym / sponsor ID
- HSC-DB-24-0062
- Conditions
- Pulp Necroses
- Keywords
- Root canal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GentleWave | Experimental | Device: GentleWave |
| EdgePro | Experimental | Device: EdgePro laser irrigation |
| Irrisafe passive ultrasonic irrigation | Active comparator | Device: Irrisafe passive ultrasonic irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent teeth that are diagnosed with pulp necrosis.
- elected to have a permanent tooth nonsurgical root canal treatment
- Signed informed consent.
Key exclusion criteria (3 listed)
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Teeth with vital pulps.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentleWaveRoot 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 | Device | GentleWave |
| EdgePro laser irrigationRoot 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 | Device | EdgePro |
| Irrisafe passive ultrasonic irrigationRoot 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 | Device | Irrisafe passive ultrasonic irrigation |
Primary outcome
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)
1 secondary outcome
Presence of proteolytic versus non-proteolytic bacteria in the root canals
Time frame: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
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One vs Two Visits Root Canal Treatments in Infected Teeth
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Effect of Apical Patency on Periapical Lesion Healing
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Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Jaramillo, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleWave, EdgePro laser irrigation and Irrisafe passive ultrasonic irrigation in people with Pulp Necroses, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 3 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 5 Sep 2025. 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 David Jaramillo, DDS ((713) 486-4224, David.E.Jaramillo@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). 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 5 Sep 2025.