An interventional study of GentleWave System in Apical Periodontitis, sponsored by University of Iowa. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by University of Iowa · Not applicable, Interventional, and Treatment
The purpose of this 12-month prospective cohort study is to evaluate post-operatory pain, patient satisfaction, and treatment outcomes (i.e., healing) when the newly-developed, 510k FDA-approved multisonic energy GentleWAve System (Sonendo, Inc., Laguna Hills, CA) is used in complex root canal procedures.
Apical Periodontitis (AP) is a disease where multiple types of bacteria, including those that can live without oxygen, create a bacterial film on the tissues around teeth. These bacteria colonize the dying pulp tissue, invade channels within teeth and other openings, and create an inflammatory response of the tissues surrounding the teeth. Therefore, the primary goal of endodontic treatment is to reduce bacteria numbers by removing remaining tissues, bacterial films, and infected dentine (i.e., layer of tooth below the enamel). Healing of apical periodontitis (AP) is expected, in the majority of cases, if proper bacterial disinfection is accomplished.
Elimination of these bacteria can be achieved by a combined action of several treatments. Lately, irrigation and mechanical instrumentation techniques have been developed with this intention. Some new technologies are based on the concept of using minimally-invasive instruments with hydrodynamic cavitation generating a broad spectrum of sound waves within the degassed fluid inside of the tooth. However, there is not enough evidence in the literature to support its efficacy.
The hypothesis of this study is that the GentleWave (GW) hydrodynamic cavitation system (Sonendo, Inc., Laguna Hills, CA) will achieve a high success rate in treating and healing apical periodontitis (AP), a disease where a bacterial film is formed on the tissues around the teeth.
246 studies on the registry are indexed under Periapical Periodontitis; 64 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 211 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.
Device: GentleWave System
The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.
Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year
This will be assessed by the evaluator measuring the estimated tooth on the CBCT and assigning an index score on the CBCT. A score of 0 denotes an intact periapical bone structure. A score of 1 denotes a diameter of periapical radiolucency \>0.5-1mm. A score of 2 denotes a diameter of periapical radiolucency \>1-2mm. A score of 3 denotes a diameter of periapical radiolucency \>2-4mm. A score of 4 denotes a diameter of periapical radiolucency \>4-8mm. A score of 5 denotes a diameter of periapical radiolucency \>8mm. A score of 6 denotes (n) + E = expansion of periapical cortical bone. A score of 7 denotes (n) + D = destruction of periapical cortical bone.
Time frame: Baseline; 6-months; 12 months
Change from baseline of peripical index (PAI) across 1 year.
This will be assessed by asking the evaluator to evaluate the PAI score at each X-ray. A value of 1 denotes normal periapical structures. A value of 2 denotes small changes in the bone structure. A value of 3 denotes changes in bone structure with some mineral loss. A value of 4 denotes apical periodontitis with well-defined radiolucent areas. A value of 5 denotes severe apical periodontitis with exacerbating features.
Time frame: Baseline; 6-months post-baseline; 12 months post-baseline
Change from baseline of modified wound healing scale (Mod-CWHS) across 1 year
This will be assessed by the evaluator evaluating the research subject's healing status on a scale of 1-3. A value of 1 is "Uneventful wound healing with no gingival edema, erythema, suppuration, discomfort or barrier exposure. A value of 2 is "Uneventful wound healing with slight gingival edema, erythema, or discomfort but no suppuration. 3 is a value of poor wound healing with significant gingival edema, erythema, discomfort, loss of barrier or any suppuration.
Time frame: 6 months post-baseline; 12 months post-baseline
Change from baseline of pain severity in 0-10 pain severity scale across 1 year
This will be assessed by asking the research subject their current level of pain on a 0-10 scale, and the patient will circle one line.
Time frame: Baseline; 2 days post-baseline; 1 weeks post-baseline; 2 weeks post-baseline; 6 months post-baseline; 12-months post-baseline
Change from Day 2 of research subject's thoughts on treatment result across 1 year.
This will be assessed by asking the research subject to assess their own treatment result on a scale of 0 to 10 and circling one line.
Time frame: 2 days post-baseline; 1-week post-baseline; 2-weeks post-baseline; 6-months post-baseline; 12 months post-baseline
Plan to share: No
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Iowa