Endodontic Disease, Periapical Diseases, Periapical Periodontitis, Root Canal Infection
Conditions
Brief summary
Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates. Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients. Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.
Detailed description
This is a single-blinded, block randomized control trial study, 120 participants will be recruited with 40 participants randomly allocated to the GWS treatment group, 40 randomly allocated to the WL treatment group, and 40 randomly allocated to the control group (CG) receiving PUI treatment (Fig 1). Participants will be selected consecutively based on our inclusion and exclusion criteria. Participants will be recruited and treated at a single site, the University of North Carolina at Chapel Hill Adams School of Dentistry (UNC-CH ASoD) Endodontic Clinic. There will be an initial baseline/screening appointment that may or may not develop into the first treatment appointment, followed by a potential second treatment appointment to complete treatment as per current treatment protocols in the Endodontic Clinic. Then participants will be followed for 12 months to evaluate clinical and radiographic healing of periapical lesions. Investigators will also assess clinician and patient opinion of the treatment modality employed in addition to calculation of a cost-time ratio. Patients will receive endodontic treatment for endodontic infections with potential improvements in procedure outcomes, number of visits, and patient intraprocedural comfort. There are the same risks for any root canal procedure that can include intraprocedural or postoperative sensitivity, inflammation infection, numbness, intraprocedural or postoperative pain, reaction to materials used, sodium hypochlorite extrusion, instrument fracture, or perforation. The investigators will manage these risks through execution of proper instrument usage and adherence to clinical protocols. The investigators do not anticipate difficulty in recruiting the required number of study participants based on the number of patients seen annually. Each week, approximately fifty patients are seen in the ASoD clinic for endodontic treatment, of which at least 50% meet the inclusion criteria for our study. There are nine trained residents in endodontics who carry out approximately five-six treatments per week. Nevertheless, all subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. A subject may leave at any time if the subject and/or investigator feel that it is not in the subject's best interest to continue. Study participants will be consecutively recruited from the Endodontic Clinic at UNC-CH ASoD. Specifically, they will be patients seeking endodontic treatment at ASoD. At the consult/treatment appointment, screened potential participants meeting the inclusion/exclusion criteria will be informed of the study and potential treatment modalities by a member of the research team who is not the treating clinician. Patients will be given adequate time to decide if they would like to participate. Once a participant consents/assents to participation in the study, they will be randomly allocated to either the control group, GentleWave treatment group, or the Waterlase treatment group in a block randomized manner. Once a participant is assigned a treatment, the treatment will take place at the same appointment as the baseline/screening appointment or scheduled for another appointment. Treatment will be completed in one or possibly two appointments. Thereafter, the patient will be scheduled for a 12-month follow up visit to evaluate clinical and radiographic healing of the periapical lesion and tooth. This follow-up appointment, depending on the amount of treatment appointments required to complete treatment, may be the second, third, or fourth appointment. Patients who agree to participate in the study will be randomized to either the GWS, WL, or control groups. As previously mentioned, each treatment group consists of 40 patients. Eight blocks of fifteen treatments (five of each treatment type) will be used. Once a patient consents/assents to participation in the study, a third party will be contacted who has access to the block randomization and they will inform the research team which treatment the patient is to undergo. This will help with organization of the treatment room with the appropriate equipment. Patient details and treatment allocation will be recorded on a password-protected Excel spreadsheet.
Interventions
DEVICEIrrisafe ip
This portion of endodontic treatment includes chemical disinfection of the root canal system with these different devices that activate the disinfection solution and distribute it throughout the root canal system with ultrasonic energy.
DEVICEGentleWave System
Prepare, clean and irrigate root canals including activation of the disinfection solution and distribution throughout the root canal system.
DEVICEWaterlase iPlus
Prepare tooth and root canal, including enlargement, to debride, clean and disinfect after endodontic treatment.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is a single blinded study. Following randomization, the participant and treating clinician will not be blinded from the treatment. Reviewers of all data collected will be blinded to the treatment modality provided.
Intervention model description
In this block-randomized, single-blinded, randomized control trial, 120 participants will be recruited with 40 participants allocated to the GentleWave System treatment group, 40 participants allocated to the Waterlase treatment group, and 40 participants allocated to a control group receiving commonly used passive ultrasonic irrigation treatment.
Eligibility
Sex/Gender
ALL
Age
14 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female patients 14 years of age or older (maximum of 99 years of age) o Participants 14 years of age or older are expected to have permanent teeth erupted in full permanent dentition with close apices * The subject tooth is indicated for root canal treatment * One tooth indicated per participant * Permanent tooth requiring root canal treatment which are deemed restorable * Teeth exhibiting pulpal pathosis (irreversible pulpitis, pulpal necrosis, previously initiated root canal treatment) and apical periodontitis (with radiographic demonstration of periapical bone loss) * Patient-signed informed consent/assent form * Patients display good compliance o Patient is determined cooperative by provider during initial exam and radiographic acquisition
Exclusion criteria
* Patients allergic to local or topical anesthetics, heart disease (pacemakers, implantable defibrillators), lung disease, bleeding disorders, immune system deficiency * Subject tooth is not clinically restorable (prosthetically or periodontally) * Mobility scores greater than or equal to 2 * Periodontal pocket depths greater than or equal to 6mm * Cracks with radicular extension, vertical root fracture or horizontal - oblique fracture * Subject tooth with open or incomplete apices (apical diameter greater than 1mm) * Subject tooth has insufficient tooth structure to create GWS platform * Subject tooth has external cervical root resorption * Subject tooth has signs of dens invaginatus * Subject tooth has signs of a palatogingival groove * Subject tooth has root(s) which communicate with the maxillary antrum * Patient has nonodontogenic facial pain * Patient requires multiple teeth to be endodontically treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periapical Index Score | 12 months | A combination of the clinical findings and Periapical Index Scores (PAI) score will be used to determine the primary outcome measure as healed, healing, or diseased as per the following descriptions: (i) Healed: Clinical normalcy other than tenderness to percussion accompanied by PAI scores of 1 or 2 (ii) Healing: Clinical normalcy other than tenderness to percussion accompanied by a reduction in the size of the periradicular lesion denoted by a reduction in the PAI score (iii) Diseased: The presence of clinical signs and symptoms accompanied by a PAI score of 3 or higher or an increase in the PAI score This is a scale of 1-5, where generally a higher number means poorer healing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Responses to Questionnaires About Treatment Procedure | within 1 week after treatment completion | Questionnaires were sent to patients within 24-48 hours after the initial treatment was completed with various structured questions utilizing the Likert scale. For example, questions consisted of "During my endodontic treatment, I felt comfortable (strongly disagree (1) to strongly agree (5)". Higher score closes to 5 represent higher levels of agreement and lower scores closer to 1 represent higher levels of disagreement with the specific questions. Responses were accepted up to one week after being sent. |
| Patients' Subjective Post-Operative Swelling | from receipt of questionnaire (24-48 hours) for up to 1 week | Questionnaires were sent to patients within 24-48 hours after the initial treatment was completed answering the question "Did you experience swelling or bruising after treatment?" using a yes/no response structure. |
| Pain Level During Various Time Frames of Treatment | 24-48 hours after treatment | Patients used a visual analog scale (from 0 to 10) to indicate "no pain at all" (i.e., 0) to the "worst pain" (i.e., 10) to assess pre-treatment, inter-treatment, and post-operative pain. Surveys were sent to participants 24-48 hours after treatment to characterize the treatment experience before, during, and within 24 hours afterwards. |
| Mean Provider Responses to Questionnaires About Treatment Procedure | within 1 week after treatment completion | An in-house developed questionnaire was sent to providers within 24-48 hours after the initial treatment was completed with various structured questions utilizing the Likert scale. For example, questions consisted of "During my endodontic treatment, I felt comfortable (strongly disagree (1) to strongly agree (5)". Higher scores show a higher level of agreement. Responses were accepted up to one week after being sent. |
| Estimated Per-Procedure Treatment Cost | from start to finish of 1-hour treatment procedure | This outcome assesses the cost per treatment procedure (in U.S. dollars) by arm during the 1-hour treatment procedure. It was pre-specified to report a single dollar amount that each participant incurred to reflect the real-world cost for private practice. Cost includes general implementation of each device for a single treatment. This is a fixed estimate per procedure cost and this value was calculated for each arm based on the cost of perishable components that can only be used once per treatment, overall cost of the device, and maintenance fees. These values were obtained by reviewing billing and purchasing records for the devices. No participant-level cost data were collected or analyzed. This outcome does not represent participant-level observations; only one calculated cost value exists for each treatment arm. Therefore, the reported values represent a single calculated cost estimate for each treatment arm, and measures of central tendency and dispersion are not applicable. |
| Number of Providers Who Responded | 12 months | Semi-structured interviews were conducted with providers after completion of all treatments to further assess responses to the initial post-operative survey. Interview questions were open-ended and focused on predefined thematic areas. Responses were analyzed and summarized according to the four most frequently identified themes reported by providers. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGlenn Karunanayake, BDS, MS
University of North Carolina, Chapel Hill
Participant flow
Pre-assignment details
Six UNC dental school providers participated but did not sign informed consent and were not considered study participants although they provided responses to questionnaires.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 19 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 2 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
None listed