Clinical trial NCT04966169: Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
Official title: Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Apical Periodontitis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 1st 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).

Exclusion Criteria:

* 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
* Advanced untreated periodontal disease or recent periodontal surgery.

Primary outcomes:
measure: Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year
timeFrame: Baseline; 6-months; 12 months
measure: Change from baseline of peripical index (PAI) across 1 year.
timeFrame: Baseline; 6-months post-baseline; 12 months post-baseline
measure: Change from baseline of modified wound healing scale (Mod-CWHS) across 1 year
timeFrame: 6 months post-baseline; 12 months post-baseline
measure: Change from baseline of pain severity in 0-10 pain severity scale across 1 year
timeFrame: Baseline; 2 days post-baseline; 1 weeks post-baseline; 2 weeks post-baseline; 6 months post-baseline; 12-months post-baseline
measure: Change from Day 2 of research subject's thoughts on treatment result across 1 year.
timeFrame: 2 days post-baseline; 1-week post-baseline; 2-weeks post-baseline; 6-months post-baseline; 12 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry and Dental Clinics
state: Iowa
Study officials:
affiliation: University of Iowa College of Dentistry
name: Fabricio Teixeira, DDS,MS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.