Study protocol: understanding pain after dental procedures, an observational study within the National Dental PBRN.

BACKGROUND: Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make sense of the data, and, ultimately, use the data to create meaningful impact all influence the success of using patient-reported outcomes. OBJECTIVES: The primary objective is to assess post-operative pain experiences by dental procedure type through 21 days post-procedure as reported by patients following dental procedures and assess patients' satisfaction with pain management following dental surgical procedures. Secondary objectives are to: 1) assess post-operative pain management strategies 1 week following dental surgical procedures, as recommended by practitioners and reported by patients, and 2) evaluate practitioner and patient acceptance of the FollowApp.Care post visit patient monitoring technology (FollowApp.Care). We will evaluate FollowApp.Care usage, perceived usefulness, ease of use, and impact on clinical workload. DESIGN AND METHODS: We describe the protocol for an observational study involving the use of the FollowApp.Care platform, an innovative mobile application that collects dental patients' assessments of their post-operative symptoms (e.g., pain). The study will be conducted in collaboration with the National Dental Practice-based Research Network, a collective Network of dental practices that include private and group practices, public health clinics, community health centers and Federal Qualified Health Centers, academic institutional settings, and special patient populations. We will recruit a minimum of 150 and up to 215 dental providers and up to 3147 patients who will receive push notifications through text messages FollowApp.Care on their mobile phones at designated time intervals following dental procedures. This innovative approach of implementing an existing and tested mobile health system technology into the real-world dental office setting will actively track pain and other complications following dental procedures. Through patients' use of their mobile phones, we expect to promptly and precisely identify specific pain levels and other issues after surgical dental procedures. The study's primary outcome will be the patients' reported pain experiences. Secondary outcomes include pain management strategies and medications implemented by the patient and provider and perceptions of usefulness and ease of use by patients and providers.

Acceptance and Usability of an Innovative mDentistry eHygiene Model Amid the COVID-19 Pandemic Within the US National Dental Practice-Based Research Network: Mixed Methods Study.

BACKGROUND: Amid the COVID-19 pandemic and other possible future infectious disease pandemics, dentistry needs to consider modified dental examination regimens that render quality care and ensure the safety of patients and dental health care personnel (DHCP). OBJECTIVE: This study aims to assess the acceptance and usability of an innovative mDentistry eHygiene model amid the COVID-19 pandemic. METHODS: This pilot study used a 2-stage implementation design to assess 2 critical components of an innovative mDentistry eHygiene model: virtual hygiene examination (eHygiene) and patient self-taken intraoral images (SELFIE), within the National Dental Practice-Based Research Network. Mixed methods (quantitative and qualitative) were used to assess the acceptance and usability of the eHygiene model. RESULTS: A total of 85 patients and 18 DHCP participated in the study. Overall, the eHygiene model was well accepted by patients (System Usability Scale [SUS] score: mean 70.0, SD 23.7) and moderately accepted by dentists (SUS score: mean 51.3, SD 15.9) and hygienists (SUS score: mean 57.1, SD 23.8). Dentists and patients had good communication during the eHygiene examination, as assessed using the Dentist-Patient Communication scale. In the SELFIE session, patients completed tasks with minimum challenges and obtained diagnostic intraoral photos. Patients and DHCP suggested that although eHygiene has the potential to improve oral health care services, it should be used selectively depending on patients' conditions. CONCLUSIONS: The study results showed promise for the 2 components of the eHygiene model. eHygiene offers a complementary modality for oral health data collection and examination in dental offices, which would be particularly useful during an infectious disease outbreak. In addition, patients being able to capture critical oral health data in their home could facilitate dental treatment triage and oral health self-monitoring and potentially trigger oral health-promoting behaviors.

Risk indicators for the presence and extent of root caries among caries-active adults enrolled in the Xylitol for Adult Caries Trial (X-ACT).

OBJECTIVE: This paper uses baseline data from a randomized clinical trial to evaluate cross-sectional indicators of root caries in caries-active adults. MATERIALS AND METHODS: Adults (21-80 years) having at least 12 erupted teeth and between one and ten caries lesions were enrolled. Participants (n = 437) received caries exams by trained, calibrated examiners and responded to baseline demographic and medical-dental questionnaires. We examined associations between baseline characteristics and (1) the presence of any root caries using Mantel-Haenszel hypothesis tests and odds ratio (OR) estimators and (2) the number of root surfaces with caries among study participants with exposed root surfaces (n = 349) using Mantel-Haenszel mean score tests and Mann-Whitney estimators. RESULTS/CONCLUSIONS: Adjusting for study site and age, male gender [OR, 1.72; 95% confidence interval (CI), 1.08, 2.78], white race (OR, 2.39; 95% CI, 1.43, 3.98), recent dental visit (OR, 1.98; 95% CI, 1.07, 3.66), poor self-described oral health (OR, 2.65; 95% CI, 1.10, 6.39), and recent professional fluoride treatment (OR, 1.85; 95% CI, 1.06, 3.25) were significantly associated with increased odds to have any root caries, and study participants with exposed root surfaces characterized by male gender [Mann-Whitney probability estimate (MW) = 0.57; 95% CI, 0.51, 0.63), white race (MW, 0.61; 0.55, 0.68), recent dental visit (MW, 0.58; 0.50, 0.67), poor self-described oral health (MW, 0.61; 0.53, 0.69), and flossing at least once per day (MW, 0.57; 95% CI, 0.51, 0.62) were significantly more likely to have a greater number of root surfaces with caries than a randomly selected study participant from their respective complementary subgroups (female gender, non-white, etc.). CLINICAL RELEVANCE: Our findings may help identify individuals at higher root caries risk.

Assessment of an Innovative Mobile Dentistry eHygiene Model Amid the COVID-19 Pandemic in the National Dental Practice-Based Research Network: Protocol for Design, Implementation, and Usability Testing.

BACKGROUND: Amid COVID-19, and other possible future infectious disease pandemics, dentistry needs to consider modified dental examination regimens that render quality care, are cost effective, and ensure the safety of patients and dental health care personnel (DHCP). Traditional dental examinations, which number more than 300 million per year in the United States, rely on person-to-person tactile examinations, pose challenges to infection control, and consume large quantities of advanced-level personal protective equipment (PPE). Therefore, our long-term goal is to develop an innovative mobile dentistry (mDent) model that takes these issues into account. This model supplements the traditional dental practice with virtual visits, supported by mobile devices such as mobile telephones, tablets, and wireless infrastructure. The mDent model leverages the advantages of digital mobile health (mHealth) tools such as intraoral cameras to deliver virtual oral examinations, treatment planning, and interactive oral health management, on a broad population basis. Conversion of the traditional dental examinations to mDent virtual examinations builds upon (1) the reliability of teledentistry, which uses intraoral photos and live videos to make diagnostic decisions, and (2) rapid advancement in mHealth tool utilization. OBJECTIVE: In this pilot project, we designed a 2-stage implementation study to assess 2 critical components of the mDent model: virtual hygiene examination (eHygiene) and patient self-taken intraoral photos (SELFIE). Our specific aims are to (1) assess the acceptance and barriers of mDent eHygiene among patients and DHCP, (2) assess the economic impact of mDent eHygiene, and (3) assess the patient's capability to generate intraoral photos using mHealth tools (exploratory aim, SELFIE). METHODS: This study will access the rich resources of the National Dental Practice-Based Research Network to recruit 12 dentists, 12 hygienists, and 144 patients from 12 practices. For aims 1 and 2, we will use role-specific questionnaires to collect quantitative data on eHygiene acceptance and economic impact. The questionnaire components include participant characteristics, the System Usability Scale, a dentist-patient communication scale, practice operation cost, and patient opportunity cost. We will further conduct a series of iterative qualitative research activities using individual interviews to further elicit feedback and suggestion for changes to the mDent eHygiene model. For aim 3, we will use mixed methods (quantitative and qualitative) to assess the patient's capability of taking intraoral photos, by analyzing obtained photos and recorded videos. RESULTS: The study is supported by the US National Institute of Dental and Craniofacial Research. This study received "single" institutional review board approval in August 2021. Data collection and analysis are expected to conclude by December 2021 and March 2022, respectively. CONCLUSIONS: The study results will inform the logistics of conducting virtual dental examinations and empowering patients with mHealth tools, providing better safety and preserving PPE amid the COVID-19 and possible future pandemics. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/32345.

Four "lessons learned" while implementing a multi-site caries prevention trial.

As the number of dental-related randomized clinical trials (RCTs) increases, there is a need for literature to help investigators inexperienced in conducting RCTs design and implement studies. This commentary describes four "lessons learned" or considerations important in the planning and initial implementation of RCTs in dentistry that, to our knowledge, have not been discussed in the general dental literature describing trial techniques. These considerations are a) preparing or securing a thorough systematic review; b) developing a comprehensive set of study documents; c) designing and testing multiple recruitment strategies; and d) employing a run-in period prior to enrollment. Attention to these considerations in the planning phases of a dental RCT can help ensure that the trial is clinically relevant while also maximizing the likelihood that its implementation will be successful.

Referring Hospitalized Smokers to Outpatient Quit Services: A Randomized Trial.

INTRODUCTION: Linking outpatient cessation services to bedside counseling for hospitalized smokers can improve long-run quit rates. Adding an assisted referral (AR) offer to a tobacco treatment specialist consult service fits the team approach to care in U.S. hospitals. DESIGN: A two-arm patient-randomized trial tested the effectiveness of adding an AR offer to outpatient smoking-cessation services and interactive voice recognition (AR+IVR) follow-up to a usual care (UC) tobacco-cessation consult for hospitalized smokers. SETTING/PARTICIPANTS: Over 24 months (November 2011-November 2013), 898 hospitalized adult smokers interested in quitting smoking were recruited from three large hospitals in the Portland, Oregon, area: an integrated group model HMO (n=622), a community hospital (n=195), and an academic health center (n=81). INTERVENTION: Tobacco treatment specialists identified smokers and provided an intensive bedside tobacco use assessment and cessation consultation (UC). AR+IVR recipients also received proactive ARs to available outpatient counseling programs and medications, and linked patients to a tailored IVR telephone follow-up system. MAIN OUTCOME MEASURES: The primary outcome was self-reported 30-day abstinence at 6-month follow-up. Secondary outcomes included self-reported and continuous abstinence and biochemically confirmed 7-day abstinence at 6 months. Follow-up was completed in September 2014; data were analyzed in 2015. RESULTS: A total of 597 and 301 hospitalized smokers were randomized to AR+IVR and UC, respectively. AR+IVR and UC recipients received 19.3 and 17.0 minutes of bedside counseling (p=0.372), respectively. Most (58%) AR+IVR patients accepted referrals for counseling, 43% accepted medications, and 28% accepted both. Self-reported 30-day abstinence for AR+IVR (17.9%) and UC (17.3%) were not statistically significant (p=0.569). Differences in 7-day, continuous, and biochemically confirmed abstinence by treatment group also were insignificant, overall and adjusting for site. CONCLUSIONS: Adding an AR to outpatient counseling and medications did not increase cigarette abstinence at 6 months compared to UC alone.

Results from the Xylitol for Adult Caries Trial (X-ACT).

BACKGROUND: Although caries is prevalent in adults, investigators have tested few preventive therapies in adult populations. In a randomized controlled trial, the authors evaluated the effectiveness of xylitol lozenges in preventing caries in adults at elevated risk of developing caries. METHODS: The Xylitol for Adult Caries Trial (X-ACT) was a three-site placebo-controlled randomized trial. Participants (n = 691) aged 21 through 80 years consumed five 1.0-gram xylitol or placebo lozenges daily for 33 months. They underwent clinical examinations at baseline and at 12, 24 and 33 months. RESULTS: Xylitol lozenges reduced the caries increment 10 percent. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. CONCLUSIONS: Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among adults at an elevated risk of developing caries. CLINICAL IMPLICATIONS: These results suggest that xylitol used as a supplement in adults does not reduce their caries experience significantly.