Dental evaluation and clearance prior to allogeneic hematopoietic cell transplantation.

INTRODUCTION: Dental examination and stabilization are performed prior to allogeneic hematopoietic cell transplantation to decrease infection risk during neutropenia. Burden of dental disease and treatment need is not well characterized in this population. OBJECTIVES: This report describes the dental status of a cohort of patients within the Chronic Graft-versus-Host Disease Consortium and treatment rendered prior to transplant. METHODS: The cohort included 486 subjects (Fred Hutchinson: n = 245; Dana-Farber: n = 241). Both centers have institutional-based dental clearance programs. Data were retrospectively abstracted from medical records by calibrated oral health specialists. RESULTS: The median age at transplant was 55.9 years, 62.1% were male, and 88% were white. Thirteen patients were edentulous (2.7%). The mean teeth among dentate patients before clearance was 26.0 (SD, 4.6). Dental findings included untreated caries (31.2%), restorations (91.6%), endodontically treated teeth (48.1%), and dental implants (5.7%). Pretransplant procedures during clearance included endodontic therapy (3.6%; mean = 0.1 teeth), restorations (25.1%; mean = 0.7), dental prophylaxis (59.2%), scaling/root planing (5.1%), and extraction (13.2%; mean = 0.3). The mean teeth after clearance was 25.6 (SD, 5.0). CONCLUSIONS: Retrospective analysis of pre-AlloHCT dental data in subjects at two large transplant centers identified low levels of dental need. Findings suggest high access to care.

Effect of birth season on anthropometrics and diseases of bone mineralization in the US population.

OBJECTIVES: Birth season has been inconsistently associated with anthropometrics, bone fractures, and malocclusion. Our aim was to assess the association between birth season and anthropometrics (height, weight, birth weight), bone fractures and dental malocclusion in the United States. METHODS: US surveys conducted between 1963-1973 assessed 16 152 6-to-21-year-old participants. Prevalence ratios and mean differences were estimated using linear models using fall as reference. RESULTS: Participants born in spring, when compared to fall, were of similar height (mean difference (MD) in height-adjusted Z score 0.03, 95% Confidence Interval (CI): -0.01 to 0.08; P-value = .17), weight (MD for weight-adjusted Z-score 0.00, 95% CI: -0.05 to 0.04; P-value =0.83), had similar rates of bone fractures (Prevalence Rate [PR] 1.07; 95% CI: 0.94 to 1.22; P-value = .28) and similar rates of dental malocclusion (MD of malocclusion index HLD -0.16; 95% confidence interval - 0.39 to 0.07; P = .18). CONCLUSION: We did not find an impact of birth season on anthropometrics, bone fractures, and dental malocclusions.

NO EVIDENCE THAT PERIODONTAL DISEASES CAUSE LUNG CANCER.

ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION: Relationship between periodontal disease and lung cancer: A systematic review and meta-analysis. Wang J, Yang X, Zou X, Zhang Y, Wang J, Wang Y. J Periodontal Res. 2020 Oct;55(5):581-593. doi:10.1111/jre.12772. Epub 2020 Jun 25. PMID: 32,583,879. SOURCE OF FUNDING: National Natural Science Foundation of China and Scientific Research foundation of the Health Planning Committee of Sichuan. TYPE OF STUDY/DESIGN: Systematic review with meta-analysis of cohort and case-control studies.

Fluoride Varnish and Dental Caries in Preschoolers: A Systematic Review and Meta-Analysis.

The aim of this study was to assess the effectiveness of fluoride varnish (FV) in reducing dentine caries at the patient, tooth, and surface levels as well as caries-related hospitalizations in preschoolers. We performed a systematic review of clinical trials of FV, alone or associated with an oral health program, compared with placebo, usual care, or no intervention. Bibliographical search included electronic searches of seven databases, registers of ongoing trials, and meeting abstracts, as well as hand searching. We performed random-effects meta-analyses and calculated confidence and prediction intervals. The search yielded 2,441 records; 20 trials were included in the review and 17 in at least one meta-analysis. Only one study had low risk of bias in all domains. We found no study reporting on caries-related hospitalizations. At the individual level, the pooled relative risk was 0.88 (95% confidence interval [CI] 0.81, 0.95); this means that in a population of preschool children with 50% caries incidence, we need to apply fluoride varnish in 17 children to avoid new caries in one child. At the tooth level, the pooled weighted mean difference was -0.30 (95% CI -0.69, 0.09) and at the surface level -0.77 (95% CI -1.23, -0.31). Considering the prediction intervals, none of the pooled estimates were statistically significant. We conclude that FV showed a modest and uncertain anticaries effect in preschoolers. Cost-effectiveness analyses are needed to assess whether FV should be adopted or abandoned by dental services.

Historical perspectives on advertising and the meme that personal oral hygiene prevents dental caries.

The consensus of a leading scientific panel in 1930 was that oral hygiene products could not prevent dental caries. Their view was that dental caries prevention required the proper mineralisation of teeth and that vitamin D could achieve this goal. Over a hundred subsequent controlled trials, conducted over seven decades, largely confirmed that this scientific panel had made the right decisions. They had, in 1930, when it comes to dental caries, correctly endorsed vitamin D products as dental caries prophylactics and oral hygiene products as cosmetics. And yet, despite this consistent scientific evidence for close to a century, an opposing conventional wisdom emerged which thrives to this day: oral hygiene habits (without fluoride) protect the teeth from dental caries, and vitamin D plays no role in dental caries prevention. This historical analysis explores whether persistent advertising can deeply engrain memes on dental caries prevention which conflict with controlled trial results. The question is raised whether professional organisations, with a dependence on advertising revenues, can become complicit in amplifying advertised health claims which are inconsistent with the principles of evidence-based medicine.

Dental enamel defects predict adolescent health indicators: A cohort study among the Tsimane' of Bolivia.

OBJECTIVES: Bioarchaeological findings have linked defective enamel formation in preadulthood with adult mortality. We investigated how defective enamel formation in infancy and childhood is associated with risk factors for adult morbidity and mortality in adolescents. METHODS: This cohort study of 349 Amerindian adolescents (10-17 years of age) related extent of enamel defects on the central maxillary incisors (none, less than 1/3, 1/3 to 2/3, more than 2/3) to adolescent anthropometrics (height, weight) and biomarkers (hemoglobin, glycated hemoglobin, white blood cell count, and blood pressure). Risk differences and 95% confidence intervals were estimated using multiple linear regression. Enamel defects and stunted growth were compared in their ability to predict adolescent health indicators using log-binomial regression and receiver operating characteristics (ROCs). RESULTS: Greater extent of defective enamel formation on the tooth surface was associated with shorter height (-1.35 cm, 95% CI: -2.17, -0.53), lower weight (-0.98 kg, 95% CI: -1.70, -0.26), lower hemoglobin (-0.36 g/dL, 95% CI: -0.59, -0.13), lower glycated hemoglobin (-0.04 %A1c , 95% CI: -0.08, -0.00008), and higher white blood cell count (0.74 109 /L, 95% CI: 0.35, 1.14) in adolescence. Extent of enamel defects and stunted growth independently performed similarly as risk factors for adverse adolescent outcomes, including anemia, prediabetes/type II diabetes, elevated WBC count, prehypertension/hypertension, and metabolic health. CONCLUSIONS: Defective enamel formation in infancy and childhood predicted adolescent health outcomes and may be primarily associated with infection. Extent of enamel defects and stunted growth may be equally predictive of adverse adolescent health outcomes.

Personal oral hygiene and dental caries: A systematic review of randomised controlled trials.

OBJECTIVE: To conduct a systematic review of randomised trials assessing the association between personal oral hygiene and dental caries in the absence of the confounding effects of fluoride. BACKGROUND: Dental caries continues to affect close to 100% of the global population. There is a century-old conflict on whether dental caries is caused by poor oral hygiene or poorly formed teeth (ie, teeth with dental defects). Resolving this conflict is of significant public health importance as these two hypotheses on dental caries aetiology can lead to different prevention strategies. METHODS: A systematic search for randomised trials was conducted using predefined criteria in 3 databases. The impact of personal oral hygiene interventions on coronal dental caries incidence was evaluated using random-effects models. RESULTS: Three randomised studies involving a total of 743 participants were included. Personal oral hygiene interventions failed to influence the incidence of dental caries (Δ Decayed, Missing and Filled Surfaces (DFMS) = -0.11; 95% confidence interval: (-0.91, 0.69; P-value < .79)) despite meticulous deplaquing of teeth. There was no significant heterogeneity in the trial results (heterogeneity chi-squared = 1.88, P = .39). The findings were robust to sensitivity analyses, including consideration of the results of nonrandomised studies. CONCLUSION: Personal oral hygiene in the absence of fluorides has failed to show a benefit in terms of reducing the incidence of dental caries.

Nutrition, dental caries and periodontal disease: a narrative review.

AIM: To provide a narrative review of the role of macro- and micronutrients in relation to dental caries, gingival bleeding and destructive periodontal disease. MATERIALS & METHODS: This review is based on systematic reviews (when available) and comparative human studies. RESULTS: Dental caries cannot develop without the presence of dietary fermentable carbohydrates, in particular sugar. The susceptibility to develop caries in the presence of carbohydrates may be influenced by genetics and micronutrients such as vitamin D. Gingival bleeding and destructive periodontal disease are sensitive markers to both abnormalities in macronutrient content (excessive carbohydrates or poly-unsaturated fat intake, deficient protein intake) and micronutrient intake (e.g. vitamin C and B12). CONCLUSION: Dental caries and periodontal diseases are a sensitive alarm bell for an unhealthy diet, which predicts the future onset of the diseases of civilizations.

Interaction of lifestyle, behaviour or systemic diseases with dental caries and periodontal diseases: consensus report of group 2 of the joint EFP/ORCA workshop on the boundaries between caries and periodontal diseases.

Periodontal diseases and dental caries are the most common diseases of humans and the main cause of tooth loss. Both diseases can lead to nutritional compromise and negative impacts upon self-esteem and quality of life. As complex chronic diseases, they share common risk factors, such as a requirement for a pathogenic plaque biofilm, yet they exhibit distinct pathophysiologies. Multiple exposures contribute to their causal pathways, and susceptibility involves risk factors that are inherited (e.g. genetic variants), and those that are acquired (e.g. socio-economic factors, biofilm load or composition, smoking, carbohydrate intake). Identification of these factors is crucial in the prevention of both diseases as well as in their management. AIM: To systematically appraise the scientific literature to identify potential risk factors for caries and periodontal diseases. METHODS: One systematic review (genetic risk factors), one narrative review (role of diet and nutrition) and reference documentation for modifiable acquired risk factors common to both disease groups, formed the basis of the report. RESULTS & CONCLUSIONS: There is moderately strong evidence for a genetic contribution to periodontal diseases and caries susceptibility, with an attributable risk estimated to be up to 50%. The genetics literature for periodontal disease is more substantial than for caries and genes associated with chronic periodontitis are the vitamin D receptor (VDR), Fc gamma receptor IIA (Fc-γRIIA) and Interleukin 10 (IL10) genes. For caries, genes involved in enamel formation (AMELX, AMBN, ENAM, TUFT, MMP20, and KLK4), salivary characteristics (AQP5), immune regulation and dietary preferences had the largest impact. No common genetic variants were found. Fermentable carbohydrates (sugars and starches) were the most relevant common dietary risk factor for both diseases, but associated mechanisms differed. In caries, the fermentation process leads to acid production and the generation of biofilm components such as Glucans. In periodontitis, glycaemia drives oxidative stress and advanced glycation end-products may also trigger a hyper inflammatory state. Micronutrient deficiencies, such as for vitamin C, vitamin D or vitamin B12, may be related to the onset and progression of both diseases. Functional foods or probiotics could be helpful in caries prevention and periodontal disease management, although evidence is limited and biological mechanisms not fully elucidated. Hyposalivation, rheumatoid arthritis, smoking/tobacco use, undiagnosed or sub-optimally controlled diabetes and obesity are common acquired risk factors for both caries and periodontal diseases.

Malnutrition-related early childhood exposures and enamel defects in the permanent dentition: A longitudinal study from the Bolivian Amazon.

OBJECTIVES: We investigated the relationship between early childhood malnutrition-related measures and subsequent enamel defects in the permanent dentition. MATERIALS AND METHODS: This cohort study included 349 Amerindian adolescents (10-17 years, 52% male) from the Bolivian Amazon. Exposures included: stunted growth (height-for-age z-scores), underweight (weight-for-age z-scores), anemia (hemoglobin), acute inflammation (C-reactive protein) and parasitic infection (hookworm). We measured the occurrence (no/yes) and extent (<1/3, 1/3-2/3, >2/3) of enamel defects. We estimated associations between childhood exposures and enamel defect measures using log-binomial and multinomial logistic regression. RESULTS: The prevalence of an enamel defect characterized by an orange peel texture on a large central depression on the labial surface of the central maxillary incisors was 92.3%. During childhood (1-4 years), participants had a high prevalence of stunted growth (75.2%), anemia (56.9%), acute inflammation (39.1%), and hookworm infection (49.6%). We observed associations between childhood height-for-age (OR = 0.65; P = 0.028 for >2/3 extent vs. no EH) and gastrointestinal hookworm infection (OR = 3.43; P = 0.035 for >2/3 extent vs. no defects or <1/3 extent) with enamel defects. DISCUSSION: The study describes a possibly novel form of enamel hypoplasia and provides evidence for associations of malnutrition-related measures in early childhood, including stunted growth and parasitic helminth infection, with the observed enamel defects.

Lower face asymmetry as a marker for developmental instability.

OBJECTIVES: Fluctuating asymmetries in the craniofacial skeleton have been shown to be predictive for mortality from degenerative diseases. We investigate whether lower face asymmetries are a potential marker for the developmental origins of health and disease. METHODS: The lower face of a representative sample of 6654 12- to 17-year old United States (US) adolescents (1966-1970, National Health Examination Survey III) was classified as asymmetric when the mandibular teeth occluded prognathically (forward) or retrognathically (backward) on one side of the face only. It was investigated whether these lower face asymmetries were directional (preferentially to the left or the right) or fluctuating (random left-right distribution) in the US population. RESULTS: Lower face asymmetries affected 1 in 4 of the US adolescents. Unilateral retrognathic dental occlusions were fluctuating asymmetries, had a US prevalence of 17.0% (95% confidence interval: 15.5-18.4) and were associated with race/ethnicity (P < .0001), not with handedness (P < .7607). Unilateral prognathic dental occlusions were directional asymmetries (P < .0001), had a US prevalence of 7.6% (95% confidence interval: 6.4-8.7) and were associated with large household size (P < .001) and handedness (P < .0223). Lower face asymmetries were not associated with distinct heritable traits such as color blindness. CONCLUSIONS: The findings suggest that lower face asymmetries are a marker for environmental stress and cerebral lateralization during early development.

Management of overbite with the Invisalign appliance.

INTRODUCTION: Most of the published literature on the management of overbite with the Invisalign appliance (Align Technology, Santa Clara, Calif) consists of case reports and case series. METHODS: In this retrospective study of 120 patients, we sought to assess the nature of overbite changes with the Invisalign appliance. Records were collected from 3 practitioners, all experienced with the Invisalign technique. The patients were consecutively treated adults (>18 years old) who underwent orthodontic treatment only with the Invisalign appliance. Patients with major transverse or anteroposterior changes or extraction treatment plans were excluded. The study sample included 68 patients with normal overbites, 40 with deepbites, and 12 with open bites. Their median age was 33 years, and 70% of the patients were women. RESULTS: Cephalometric analyses indicated that the deepbite patients had a median overbite opening of 1.5 mm, whereas the open bite patients had a median deepening of 1.5 mm. The median change for the normal overbite patients was 0.3 mm. Changes in incisor position were responsible for most of the improvements in the deepbite and open bite groups. Minimal changes in molar vertical position and mandibular plane angle were noted. CONCLUSIONS: The Invisalign appliance appears to manage the vertical dimension relatively well, and the primary mechanism is via incisor movements.

Monitoring failure rates of commercial implant brands; substantial equivalence in question?

OBJECTIVE: The aim of this study was to report on the failure rates of two distinct dental implant systems in a clinical practice setting. MATERIALS AND METHODS: Date of implant placement and loss were entered prospectively in a data registry system. Failure rates of two commercially pure titanium implants, one with a porous oxydized surface (POS) and the other with a chemically altered surface (CAS), were assessed using a quality control chart and survival analyses. RESULTS: A total of 860 POS and 759 CAS implants were placed. A warning of an increased failure rate of the CAS implant was identified by means of the quality control chart. Survival analyses indicated that the CAS implant failure rate was twice that of the POS implant (Hazard Ratio: 2.08; 95% CI: 1.33-3.28, P-value < 0.0012). After adjusting for alternative explanations, the CAS implant remained associated with a 95% increased failure rate (95% CI: 1.14-3.35; P-value = 0.0146). Abandoning the CAS implant and returning to a POS implant was associated with a non-significant 64% drop in the implant failure rate within less than a year (HR: 0.36; 95% CI: 0.12-1.14; P-value < 0.0826). CONCLUSION: The difference between a 4% failure rate with the POS implant and an 8% failure with the CAS implant appears inconsistent with the assumption of substantial equivalence.

Specific infections as the etiology of destructive periodontal disease: a systematic review.

Destructive periodontal disease has been primarily defined and investigated as an infectious disease. The aim of this study was to systematically search for cohort studies where microbiological diagnoses were performed before the onset of destructive periodontal disease and where statistically significant associations were identified. A search was executed in PubMed. The results showed that three studies published after 2005 supported the infection hypothesis for one putative periodontal pathogen: Aggregatibacter actinomycetemcomitans. These three studies were conducted in predominantly non-Caucasian pediatric populations living in geographic areas with an elevated child-mortality rate. These studies did not obtain physical or laboratory markers of health, making it possible that A. actinomycetemcomitans was not a cause but a marker for poor environmental or systemic health. No cohort studies were identified supporting the infection hypothesis in adults, Caucasians or in a population residing in areas with child-mortality rates reflective of healthy population goals. While the possibility cannot be excluded that A. actinomycetemcomitans has an etiological role in certain specific pediatric populations, there are no cohort studies supporting an infectious etiology of destructive periodontal disease in adults.

Evidence-based clinical recommendations regarding screening for oral squamous cell carcinomas.

BACKGROUND: This article presents evidence-based clinical recommendations developed by a panel convened by the American Dental Association Council on Scientific Affairs. This report addresses the potential benefits and potential risks of screening for oral squamous cell carcinomas and the use of adjunctive screening aids to visualize and detect potentially malignant and malignant oral lesions. TYPES OF STUDIES REVIEWED: The panel members conducted a systematic search of MEDLINE, identifying 332 systematic reviews and 1,499 recent clinical studies. They selected 5 systematic reviews and 4 clinical studies to use as a basis for developing recommendations. RESULTS: The panel concluded that screening by means of visual and tactile examination to detect potentially malignant and malignant lesions may result in detection of oral cancers at early stages of development, but that there is insufficient evidence to determine if screening alters disease-specific mortality in asymptomatic people seeking dental care. CLINICAL IMPLICATIONS: The panel suggested that clinicians remain alert for signs of potentially malignant lesions or early-stage cancers while performing routine visual and tactile examinations in all patients, but particularly in those who use tobacco or who consume alcohol heavily. Additional research regarding oral cancer screening and the use of adjuncts is needed.

Radiographic tips on predicting inferior alveolar nerve exposure.

SUBJECTS: The study included 230 patients (60% female) with a total of 423 wisdom tooth extractions. The patients were treated by 2 oral surgeons between July 1998 and July 2002 in the Oral and Maxillofacial Surgery Unit of the Massachusetts General Hospital in Boston, Massachusetts. GOLD STANDARD: The authors reported that the extraction was inspected for evidence of inferior alveolar nerve (IAN) exposure under direct vision using a headlight. DIAGNOSTIC TESTS: Each tooth was inspected for the presence of any of the following 5 radiographic signs: MAIN RESULTS: No IAN exposures occurred when all 5 radiographic signs were absent. Based on this study, where 189 M3 had such a radiographic presentation, we can conclude that the upper limit of the 95% confidence interval for the IAN exposure is 1.6%. None of the 5 diagnostic markers, when used in isolation, had adequate sensitivity and specificity to accurately predict an IAN nerve exposure in a clinical setting.

Private Interests and the Start of Fluoride-Supplemented High-Carbohydrate Nutritional Guidelines.

Fluoride has no tangible health benefits other than preventing dental caries and there is a small difference between its minimum effective dose and its minimum toxic dose. Leading global organizations currently recommend fluoride supplementation because they recommend high-carbohydrate diets which can cause dental caries. Low-carbohydrate diets prevent dental caries making such fluoride recommendations largely unnecessary. A dental organization was among the first to initiate the public health recommendations which started fluoride-supplemented high-carbohydrate nutritional guidelines. This start required expert panels at this dental organization to reverse on three key scientific points between 1942 and 1949: (1) that topical fluoride had potential harms, (2) that dental caries was a marker for micronutrient deficiencies, and (3) that low-carbohydrate diets are to be recommended for dental caries prevention. Internal documents show that private interests motivated the events which led these expert panels to engage in pivotal scientific reversals. These private interests biased scientific processes and these reversals occurred largely in an absence of supporting evidence. It is concluded that private interests played a significant role in the start of public health endorsements of fluoride-supplemented high-carbohydrate nutritional guidelines.

Stability of treatment for anterior open-bite malocclusion: a meta-analysis.

INTRODUCTION: Anterior open-bite (AOB) treatment is considered challenging because of difficulties in determining and addressing etiologic factors and the potential for relapse in the vertical dimension after treatment. In this review, we compiled evidence on the long-term stability of the major therapeutic interventions for correcting AOB. Our objective was to review and compile evidence for the stability of surgical and nonsurgical therapies for AOB malocclusion. Our data sources were PubMed, EMBASE, Cochrane Library, limited gray literature search, and hand searching. METHODS: A search was performed of the electronic health literature on the stability of AOB after treatment. Hand searching of major orthodontic journals and limited gray literature searching was also performed, and all pertinent abstracts were reviewed for inclusion. Full articles were retrieved for abstracts or titles that met the initial inclusion criteria or lacked sufficient detail for immediate exclusion. Studies accepted for analysis were reviewed and their relevant data retrieved for pooling. The long-term stability estimates were pooled into nonsurgical and surgical groups, and summary statistics were generated. RESULTS: One hundred five abstracts met the initial search criteria, and 21 articles were included in final analyses. Rejected articles failed to exhibit follow-up times of 12 months or more, did not include measurements of overbite (OB), or did not meet inclusion criteria. All included articles were divided into a surgical group (SX) with a mean age of 23.3 years and a nonsurgical group (NSX) with a mean age of 16.4 years. All studies were case series. Random-effects statistical models were used to pool the mean OB measures before and after treatment and also at the long-term follow-up. The pretreatment adjusted means of OB were -2.8 mm for the SX and -2.5 mm for the NSX. AOB closures up to +1.6 mm (SX) and +1.4 mm (NSX) were achieved. Relapse in the SX group during the mean 3.5 years of follow-up reduced the OB to +1.3 mm; the NSX group relapsed to +0.8 mm in the mean 3.2 years of follow-up. Pooled results indicated reasonable stability of both the SX (82%) and NSX (75%) treatments of AOB measured by positive OB at 12 or more months after the treatment interventions. CONCLUSIONS: In the included case series publications, success of both the SX and NSX treatments of AOB appeared to be greater than 75%. Because the SX and the NSX were examined in different studies and applied to different clinical populations, no direct assessment of comparative effectiveness was possible. The pooled results should be viewed with caution because of the lack of within-study control groups and the variability among studies.

Safety of an intra-oral hearing device utilizing a split-mouth research design.

OBJECTIVE: The auditory deficits of Single Sided Deafness (SSD) can be treated effectively with a novel device, SoundBite, that delivers sound by applying imperceptible vibratory signals to the teeth (hereafter referred to as an intra-oral hearing device). The intra-oral hearing device is placed around two maxillary teeth and is similar to a small partial denture or retainer. The goal of this study was to report how this removable hearing device affects the oral structures. METHODS: Twenty-two SSD patients wearing an intra-oral hearing device were enrolled in a prospective study for six months. Differences (delta) between the device-anchoring teeth and the equivalent contralateral non-device teeth were evaluated with four dental parameters using a paired t-test. Hearing thresholds were evaluated as a function of alveolar bone support using linear regression. RESULTS: Compared to the non-device teeth, the hearing device teeth did not exhibit any increased recession (delta = 0.1 mm, p-value = 0.48), increased pocket depth (delta = 0.0 mm, p-value = 0.48), increased root resorption (delta = 4%, p-value = 0.43), or increased alveolar bone loss (delta = 0.0 %, p-value = 0.43). There was no association between the amount of alveolar support and hearing thresholds (delta = 0.2, p-value = 0.34). CONCLUSION: The intra-oral component of the hearing device did not adversely affect the dental structures of the subjects in this trial.