Trial Outcomes & Findings for Comparison of Clinical Outcomes Between GentleWave® and Biolase® (NCT NCT05555043)

Six UNC dental school providers participated but did not sign informed consent and were not considered study participants although they provided responses to questionnaires.

Race and Ethnicity were not collected from any participant.

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.

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.

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.

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.

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.

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.

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.