Endodontic Disease Clinical Trial
Official title:
Comparison of Clinical Outcomes Between GentleWave® and Biolase®: A Randomized Controlled Trial
Verified date | February 2024 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Univeristy of North Carolina Adams School of Dentistry | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Periapical index score | 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. |
12 months | |
Secondary | Qualitative data from patient and provider questionnaires about treatment procedure | Secondary analyses will include summaries of questionnaires. Questionnaires will be sent out to participants after after treatment is completed with various structured questions utilizing the Likert scale. For example, questions will consist of "During my endodontic treatment, I felt comfortable (strongly disagree (1) to strongly agree (5)". Furthermore, for selected participants, semi-structured interview transcripts will undergo qualitative analysis which will consist of coding transcripts based on both deductive and inductive topics related to experiences with treatment. Data from the groups will be triangulated to assess convergence and possible differences in perceptions and preferences. Analysis will include examining co-occurrences of codes with a final report describing primary topics across all data. Specialized qualitative software, MAXQDA, will be used for coding, analysis, and generating final products such as matrices and diagrams. | from time of treatment completion to 12-month follow-up appointment, assessed up to 12 months |
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