An interventional study of GentleWave System Root Canal Therapy and EdgePro Laser Root Canal Therapy in Dental Pulp Necroses, sponsored by Abhishek Parolia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Abhishek Parolia · Not applicable, Interventional, and Basic science
Among 12 studies in Dental Pulp Necrosis with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Dental Pulp Necrosis · United States.
Among the 12 studies in Dental Pulp Necrosis with a site in United States, this one is the 2nd largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2024, is one of 6 with no phase, and was the 11th registered.
157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.
Browse Dental Pulp Necrosis studies →3 of the 12 studies in Dental Pulp Necrosis with a site in United States are open now. Recruiting first, the newest first:
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–89
The University of Texas Health Science Center, Houston · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 15 Dental Pulp Necrosis studies recruiting now, 6 (40%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 95 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 90 is above the median of 45 across 148 interventional studies indexed under Dental Pulp Necrosis.
Median enrollment 24 across the 10 interventional studies, 101 across the 2 observational. Of the 8 that completed or were terminated, 2 (25%) have results posted.
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None of the 12 has an industry lead sponsor. The 9 most frequent:
This is the only study on the registry with Abhishek Parolia as lead sponsor.
Abhishek Parolia has 1 study filed under Dental Pulp Necrosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Dental Pulp Necrosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to understand the effect that 3 different types of root canal procedures have on bacteria.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
This device has 510k market approval for its intended use within this study.
This device has 510k market approval for its intended use within this study.
This device has 510k market approval for its intended use within this study.
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.
Time frame: Baseline (pre-intervention) and during the intervention and immediately after the intervention
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2028, 48 months after the start.
Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 48 months is above that.
Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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