Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study

NCT04966169 | Terminated

• 1 other identifier: 202102255
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  2 days post-baseline; 1-week post-baseline; 2-weeks post-baseline; 6-months post-baseline; 12 months post-baseline

Study Arms (1)

Sonendo GentleWave

EXPERIMENTAL

Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.

Device: GentleWave System

Interventions

GentleWave System DEVICE

The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.

Sonendo GentleWave

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+ years
• Speak and Read English
• Able to attend follow-up visits at 6 months AND 1 year (post-baseline treatment)
• A tooth with no response to cold and electric pulp testing.
• Tooth is a 1st or 2nd mandibular molar
• Tooth has no response to cold/electric pulp testing
• Tooth has a diagnosis of pulp necrosis with asymptomatic apical periodontitis
• st and 2nd mandibular molars.
• Current (i.e., taken within the last week) radiograph available (or done at screening, as needed)
• A limited-volume, cone-beam computed tomography (CBCT) taken at the first visit confirms apical periodontitis (radiolucency).

You may not qualify if:

• Patient has advanced untreated periodontal disease/recent periodontal surgery
• Patient has non-odontogenic facial pan (e.g., face pain of unknown cause)
• Patient has a history of poor attendance at dental visits
• Patient is pregnant
• Patient reports taking corticosteroids
• Patient is supervised by the Principal Investigator or a member of the research team
• Patient is subordinate to the Principal Investigator or a member of the research team
• Patient is a student/trainee under the direction of the Principal Investigator or a member of the research team
• Tooth had previous intervention (e.g., pulp debridement: removal of the pulp/nerve of the tooth)
• Tooth has incomplete root formation (e.g., immature with apical periodontitis)
• Tooth has defective restorations or carious lesions (i.e., cavities) that could lead to microleakage
• Tooth has internal or external resorption
• Tooth has a mobility score of 3
• Tooth has a fracture/visibly cracked
• Tooth has vital (i.e., functioning) pulp

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• Grigsby D Jr, Ordinola-Zapata R, McClanahan SB, Fok A. Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. J Endod. 2020 Aug;46(8):1017-1022. doi: 10.1016/j.joen.2020.04.004. Epub 2020 Jun 14.

  PMID: 32553417 BACKGROUND

• Sigurdsson A, Le KT, Woo SM, Rassoulian SA, McLachlan K, Abbassi F, Garland RW. Six-month healing success rates after endodontic treatment using the novel GentleWave System: The pure prospective multi-center clinical study. J Clin Exp Dent. 2016 Jul 1;8(3):e290-8. doi: 10.4317/jced.52779. eCollection 2016 Jul.

  PMID: 27398180 BACKGROUND

• Sigurdsson A, Garland RW, Le KT, Woo SM. 12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. J Endod. 2016 Jul;42(7):1040-8. doi: 10.1016/j.joen.2016.04.017.

  PMID: 27325455 BACKGROUND

• Wohlgemuth P, Cuocolo D, Vandrangi P, Sigurdsson A. Effectiveness of the GentleWave System in Removing Separated Instruments. J Endod. 2015 Nov;41(11):1895-8. doi: 10.1016/j.joen.2015.08.015. Epub 2015 Sep 26.

  PMID: 26409807 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Fabricio Teixeira, DDS,MS,PhD

  University of Iowa College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 19, 2021
• Study Start: August 27, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)