Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study.

BACKGROUND: The immunogenicity and safety of a booster dose of tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT), alone or co-administered with MenB vaccine, were assessed in healthy 13-25-year olds who received MenACYW-TT or a CRM-conjugate vaccine (MCV4-CRM) 3-6 years earlier. METHODS: This phase IIIb open-label trial (NCT04084769) evaluated MenACYW-TT-primed participants, randomized to receive MenACYW-TT alone or with a MenB vaccine, and MCV4-CRM-primed participants who received MenACYW-TT alone. Functional antibodies against serogroups A, C, W and Y were measured using human complement serum bactericidal antibody assay (hSBA). The primary endpoint was vaccine seroresponse (post-vaccination titers ≥1:16 if pre-vaccination titers <1:8; or a ≥4-fold increase if pre-vaccination titers ≥1:8) 30 days post booster. Safety was evaluated throughout the study. RESULTS: The persistence of the immune response following primary vaccination with MenACYW-TT was demonstrated. Seroresponse after MenACYW-TT booster was high regardless of priming vaccine (serogroup A: 94.8% vs 93.2%; C: 97.1% vs 98.9%; W: 97.7% vs 98.9%; and Y; 98.9% vs 100% for MenACWY-TT-primed and MCV4-CRM-primed groups, respectively). Co-administration with MenB vaccines did not affect MenACWY-TT immunogenicity. No vaccine-related serious adverse events were reported. CONCLUSIONS: MenACYW-TT booster induced robust immunogenicity against all serogroups, regardless of the primary vaccine received, and had an acceptable safety profile. IMPACT: A booster dose of MenACYW-TT induces robust immune responses in children and adolescents primed with MenACYW-TT or another MCV4 (MCV4-DT or MCV4-CRM), respectively. Here, we demonstrate that MenACYW-TT booster 3-6 years after primary vaccination induced robust immunogenicity against all serogroups, regardless of the priming vaccine (MenACWY-TT or MCV4-CRM), and was well tolerated. Persistence of the immune response following previous primary vaccination with MenACYW-TT was demonstrated. MenACYW-TT booster with MenB vaccine co-administration did not affect MenACWY-TT immunogenicity and was well tolerated. These findings will facilitate the provision of broader protection against IMD particularly in higher-risk groups such as adolescents.

Differences in finished case quality between Invisalign and traditional fixed appliances.

OBJECTIVES: To compare the treatment and posttreatment effects of Invisalign aligners that incorporated SmartForce features and attachments to traditional fixed appliances. MATERIALS AND METHODS: This randomized controlled trial included 66 patients, 32 aligners, and 34 fixed-appliance patients. The median ages of the aligner and braces patients were 26.7 (interquartile range [IQR]: 9.8) and 25.9 (IQR: 16.6) years, respectively. Pretreatment occlusion was assessed using the ABO Discrepancy Index. Posttreatment (T1) and 6-month retention (T2) occlusions were quantified using the ABO Objective Grading System (OGS) scores. RESULTS: The braces group finished treatment significantly (P < .001) earlier (0.4 years) than the aligner group. The median DI scores for the aligner and braces groups were 4.5 and 7.0, respectively, which was a statistically significant (P = .015), but clinically insignificant, difference. There were no statistically significant between-group differences for the total OGS scores or any of the individual component scores at debond (T1) or after 6 months of retention (T2). During the posttreatment period, alignment and overjet worsened significantly in the aligner group, while buccolingual inclinations and occlusal relations improved. Over the same period, alignment worsened in the braces group and buccolingual inclinations improved. There was no statistically significant between-group difference in posttreatment changes of the total OGS scores. CONCLUSIONS: While patients with simple malocclusions require 4.8 months longer treatment times with aligners than traditional braces, the treatment and 6-month posttreatment occlusal outcomes are similar.

The efficacy of fluoride varnish vs a filled resin sealant for preventing white spot lesions during orthodontic treatment.

OBJECTIVES: To compare the efficacy of casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP) MI Varnish (GC America, Inc, Alsip, IL) and ProSeal (Reliance Orthodontic Products, Itasca, IL) sealant in preventing the development of white spot lesions (WSLs) in orthodontic patients. MATERIALS AND METHODS: This prospective randomized clinical trial included 40 orthodontic patients 12-17 years of age. One group had sealants placed on their anterior maxillary teeth, with reapplications every 3 months. The other group had MI Varnish applied every 4-6 weeks. WSL formation and oral hygiene were evaluated at the initial appointment before bonding (T1) and 12 months later (T2). Standardized digital photographs were analyzed using the enamel decalcification index (EDI). Statistical comparisons were made using independent and paired-sample t-tests as well as chi-square tests. RESULTS: In this trial, 43% of patients and 15% of teeth developed new WSLs. Lateral incisors showed the highest incidence of decalcification and WSL formation. WSL formation and EDI score increases during treatment were significantly greater in the gingival region than in the mesial, distal, or incisal regions. Of the EDI scores at T2, 93.8% were 0 and 5.5% were 1. Poor oral hygiene at T2 showed a high positive predictive value (76%) for the development of WSLs. There were no statistically significant between-group differences for the development of WSLs. CONCLUSIONS: MI Varnish and ProSeal sealant provided similar levels of protection during the first 12 months of fixed orthodontic treatment. The severity of the WSLs that developed was minimal. WSLs were most likely to develop on lateral incisors and in the gingival regions of teeth, especially among patients with poorer oral hygiene.

The quality of etched enamel in different regions and tooth types and its significance in bonding and the development of white spot lesions.

OBJECTIVES: To quantify differences in the etch quality of enamel within and between human teeth, which has not previously been attempted. MATERIALS AND METHODS: The buccal right and left halves of 27 extracted human teeth were randomly allocated to scanning electron microscopy (SEM) or micro-computed tomography (µCT) for evaluation. The buccal surfaces were pumiced, etched with 37% phosphoric acid gel etchant for 15 seconds, rinsed, and air dried. Each tooth was divided into three regions (incisal, middle, and cervical) and viewed after etching at 1200× magnification with SEM. The µCT scans were taken before and after etching to calculate apparent and material mineral densities. RESULTS: SEM showed greater aprismatic enamel and poorer etch quality (ie, significantly less percentage enamel) for the posterior than anterior teeth and for the cervical region than for the incisal and middle regions of all teeth. Although there were no density differences prior to etching, µCT demonstrated that etching increased material density significantly more for the anterior than posterior teeth. Prior to etching, the enamel in the cervical regions was significantly less dense than the enamel in the middle or incisal regions. Etching significantly increased the material density of all three regions, which decreased initial regional differences. After etching, the apparent density of the cervical region remained significantly lower than the densities of the other two regions. CONCLUSIONS: Based on SEM and µCT, there is greater aprismatic enamel and inferior etch quality in the cervical regions of all tooth types and is clinically significant in explaining the failure of sealant retention and the propensity for white spot lesions.

Risk assessments in orthodontic patients developing white spot lesions.

AIM: To determine whether caries risk factors, including cariogenic bacterial levels and salivary function, can be used to identify orthodontic patients who develop white spot lesions (WSL). METHODS: This prospective case-control study comprised 50 patients 11-17 years of age, including 25 controls and 25 cases who developed new WSL during treatment. WSL, oral hygiene and fluorosis were evaluated from intraoral photographs. The biofilm was assessed with bacterial cultures and adenosine triphosphate (ATP) bioluminescence. Salivary analyses were performed to determine the pH of saliva and flow rates. A survey was used to assess snacking frequency, oral hygiene and fluoride utilization. RESULTS: There were no between-group pretreatment differences in WSL. Cases reported eating sugary foods significantly more often than the controls. There was a significant decline in oral hygiene during treatment, with no significant between-group difference. There also were no statistically significant between-group differences in the amount of saliva, buffer, ATP bioluminescence and bacterial levels. Both groups showed lower than normal buffer capacity and high bacterial levels. CONCLUSION: Cases had greater sugar intake between meals than controls. ATP bioluminescence, Streptococcus mutans levels with Saliva Check Mutans, and salivary factors do not identify patients who develop WSL.

Incidence of white spot lesions among patients treated with clear aligners and traditional braces.

OBJECTIVES: To compare the incidence of white spot lesions (WSLs) among patients treated with aligners and those treated with traditional braces. MATERIALS AND METHODS: A group of 244 aligner patients (30.4 ± 14 years) was compared to a group of 206 patients (29.2 ± 11.5 years) treated with traditional fixed braces. Consecutive cases in the late mixed or permanent dentitions who had high-quality pre- and posttreatment digital photographs available were included in the study. Each set of photographs was independently evaluated by two investigators to determine pretreatment oral hygiene (OH), fluorosis, and WSLs, as well as changes in OH and WSLs during treatment. RESULTS: Approximately 1.2% of the aligner patients developed WSLs, compared to 26% of the traditionally treated patients. The numbers of WSLs that developed were also significantly (P < .001) less among the aligner patients. The aligner patients developed three new WSLs, while the traditionally treated patients developed 174 WSLs. The incidence of WSLs was greater for the maxillary than for the mandibular teeth, and it was greater for the canines than for the incisors. For the patients treated with traditional braces, fair or poor pretreatment OH, worsening of OH during treatment, preexisting WSLs, and longer treatment duration significantly (P < .05) increased the risk of developing WSLs during treatment. CONCLUSIONS: Patients treated with aligners have less risk of developing WSLs than do patients treated with traditional braces, which could be partially due to shorter treatment duration, or better pretreatment OH.

Discomfort associated with Invisalign and traditional brackets: A randomized, prospective trial.

OBJECTIVE: To evaluate differences in discomfort levels between patients treated with aligners and traditional fixed orthodontic appliances. MATERIALS AND METHODS: This blinded, prospective, randomized equivalence two-arm parallel trial allocated 41 adult Class I nonextraction patients to either traditional fixed appliance (6 males and 12 females) or aligner (11 males and 12 females) treatment. Patients completed daily discomfort diaries following their initial treatment appointment, after 1 month and after 2 months. They recorded their levels of discomfort at rest, while chewing, and while biting, as well as their analgesic consumption and sleep disturbances. RESULTS: Both treatment modalities demonstrated similar levels of initial discomfort. There were no significant sex differences. Patients in the traditional fixed appliances group reported significantly (P < .05) greater discomfort than patients in the aligner group during the first week of active treatment. There was significantly more discomfort while chewing than when at rest. Traditional patients also reported significantly more discomfort than aligner patients after the first and second monthly adjustment appointments. Discomfort after the subsequent adjustments was consistently lower than after the initial bonding or aligner delivery appointments. A higher percentage of patients in the fixed-appliance group reported taking analgesics during the first week for dental pain, but only the difference on day 2 was statistically significant. CONCLUSIONS: Patients treated with traditional fixed appliances reported greater discomfort and consumed more analgesics than patients treated with aligners. This trial was not registered.

Prevalence of white spot lesion formation during orthodontic treatment.

PURPOSE: To quantify the prevalence of white spot lesions (WSLs) on the anterior teeth and, secondarily, to evaluate risk factors and predictors. MATERIALS AND METHODS: Digital photographs and records of 885 randomly chosen patients were evaluated before and after treatment. Chart information included gender, age, as well as banding and debanding dates. Fluorosis and oral hygiene before and after treatment were also evaluated. Preexisting and posttreatment WSLs were recorded and compared for all 12 anterior teeth. Risk ratios (RR) and absolute risk (AR) were calculated to determine the likelihood and risk of WSL formation. RESULTS: Overall, 23.4% of the patients developed at least one WSL during their course of treatment. Maxillary anterior teeth were affected more than mandibular teeth. The maxillary laterals and canines and the mandibular canines were the most susceptible. There was no significant difference in WSLs between genders. Fluorosis, treatment time in excess of 36 months, poor pretreatment hygiene, hygiene changes during treatment, and preexisting WSLs were all significantly (P < .05) related to the development of WSLs. The highest risk of developing WSLs was associated with preexisting WSLs (RR = 3.40), followed by declines in oral hygiene during treatment (RR = 3.12) and poor pretreatment oral hygiene (RR = 2.83). CONCLUSIONS: Nearly 25% of the patients developed WSLs while in treatment, depending on fluorosis, treatment time, preexisting WSLs, and oral hygiene. Orthodontists need to be mindful of these risk factors when making treatment decisions.