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

Primary Purpose

Apical Periodontitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GentleWave System
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Iowa College of Dentistry and Dental Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sonendo GentleWave

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2021
Last Updated
October 11, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT04966169
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sonendo GentleWave
Arm Type
Experimental
Arm Description
Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.
Intervention Type
Device
Intervention Name(s)
GentleWave System
Intervention Description
The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.
Primary Outcome Measure Information:
Title
Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year
Description
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
Title
Change from baseline of peripical index (PAI) across 1 year.
Description
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
Title
Change from baseline of modified wound healing scale (Mod-CWHS) across 1 year
Description
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
Title
Change from baseline of pain severity in 0-10 pain severity scale across 1 year
Description
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
Title
Change from Day 2 of research subject's thoughts on treatment result across 1 year.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabricio Teixeira, DDS,MS,PhD
Organizational Affiliation
University of Iowa College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa College of Dentistry and Dental Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32553417
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.
Results Reference
background
PubMed Identifier
27398180
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.
Results Reference
background
PubMed Identifier
27325455
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.
Results Reference
background
PubMed Identifier
26409807
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.
Results Reference
background

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

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