Category: Statistics

Rheumatology (Oxford). 2021 Dec 17:keab933. doi: 10.1093/rheumatology/keab933. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare treatment retention between biosimilars and their originator products among first starters (etanercept, infliximab, adalimumab and rituximab), as well as after non-medical switch.

METHODS: Patients with rheumatic diseases starting, for the first time, an originator or biosimilar etanercept, infliximab, adalimumab, and rituximab were identified in the national Swedish Rheumatology Quality register. Moreover, patients switching from an originator to its biosimilar were identified, and individually matched to patients continuing on the originator. One-year treatment retention was calculated, and hazard ratios (HR) for discontinuation with 95% confidence intervals (CI) were estimated, adjusting for comorbidities and socioeconomic factors.

RESULTS: In total, 21443 first treatment courses were identified. The proportion of patients still on drug at one year, and the HR for discontinuation, revealed no differences across adalimumab (Humira, Imraldi, Amgevita and Hyrimoz) nor across rituximab products (Mabthera, Ritemvia/Truxima and Rixathon). The proportions on drug at one year were similar for Benepali (77%) and Enbrel (75%) and the adjusted HR for Benepali compared to Enbrel was 0.91 (95% CI: 0.83-0.99). For infliximab, the proportion still on drug at one year was 67% for Remicade and 66% for Remsima/Inflectra, and the HR in comparison with Remicade was: 1.16 (95% CI: 1.02-1.33).Among 2925 patients switching from an originator drug to one of its biosimilars, we noted no statistically significant or clinically relevant differences in drug survival compared those who remained on originator therapy.

CONCLUSION: This large observational study supports the equivalence of bDMARD biosimilar products and originators when used in routine rheumatology care.

PMID:34919663 | DOI:10.1093/rheumatology/keab933

Rheumatology (Oxford). 2021 Dec 17:keab931. doi: 10.1093/rheumatology/keab931. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine whether early therapeutic intervention, compared with delayed intervention, is beneficial for patients with early systemic sclerosis (SSc).

METHODS: This is a single-center, retrospective cohort study of SSc patients who received cyclophosphamide, mycophenolate mofetil, methotrexate, or tocilizumab for diffuse cutaneous SSc (dcSSc) or interstitial lung disease (ILD) within 6 years after disease onset. The patients were divided into early and delayed intervention groups based on the disease duration of ≤ 18 and >18 months at treatment introduction, respectively. Clinical worsening was defined as the development of any original or revised ACR Composite Response Index in Systemic Sclerosis (CRISS) step 1 event or progressive fibrosing ILD (PF-ILD).

RESULTS: There was no difference in baseline characteristics between the early (n = 25) and delayed (n = 21) intervention groups except forced vital capacity (FVC), which was better in the early vs delayed intervention groups. The early intervention group less frequently had stable pulmonary function over one year than did the late intervention group (odds ratio 0.087, 95% confidence interval 0.0079-0.51, p = 0.003). The active disease was significantly decreased from 79% to 42% in the early intervention group (p = 0.007), but the change in the delayed intervention group was not statistically significant (68% to 42%, p = 0.11). Cumulative rates free from clinical worsening events defined by revised ACR-CRISS and PF-ILD were significantly higher in the early vs delayed intervention groups (p = 0.03 and 0.003, respectively).

CONCLUSION: A therapeutic “window of opportunity” might exist in SSc patients.

PMID:34919668 | DOI:10.1093/rheumatology/keab931

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):1235-1246R. doi: 10.11607/jomi.8799.

ABSTRACT

PURPOSE: Patients with maxillary defects after a maxillectomy live with a range of functional and social problems. As techniques for functional reconstruction of the maxilla have been applied in a number of these patients, some of them regained confidence in their lives again. Nevertheless, there was still no clear consensus on the connecting and loading patterns of zygomatic implant-supported prosthetics in bilateral maxillary defects. This study aimed to investigate the function of a novel technique using “three-dimensional ring”-supported prosthetics based on zygomatic implants and compared its effects with two other conventional approaches through assessing the quality of the patient’s life.

MATERIALS AND METHODS: Forty-five eligible patients who had different degrees of maxillectomy received treatment of conventional prostheses with a clasp (25 patients, group 1), a regular implant with obturator removal (10 patients, group 2), or a zygomatic implant combined with “three-dimensional ring”-supported prosthetics (10 patients, group 3). A questionnaire that included the indicators of the Obturator Functioning Scale (OFS) and EORTC Head and Neck 35 assessment was employed to evaluate the functional rehabilitation and quality of life (QOL) of patients in the study. The data were then summarized into a worksheet (Excel 2010), and the mean and standard deviation were calculated. The data were processed with SPSS 19.0 for Windows statistical software.

RESULTS: The questionnaire analysis showed a statistically significant difference in the OFS, EORTC H&N 35, and QOL scores between group 3 and group 1 or group 2. Importantly, in the assessment of EORTC H&N 35, the proportion of patients in group 3 who lost weight after the functional restoration of maxillary defection was lower than that of the other two groups. In this research, a new connection device mode, which provided a retentive force between the zygomatic implants and prosthetics through a 3D ring-shaped milling bar with golden galvanized frames, was conducted and proved to be a reliable and feasible functional reconstruction therapy through patients’ questionnaire surveys.

CONCLUSION: This research provided an effective reconstruction strategy for patients with maxillary resection that could remarkably improve the life quality of patients.

PMID:34919626 | DOI:10.11607/jomi.8799

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):e175-e182. doi: 10.11607/jomi.9029.

ABSTRACT

PURPOSE: There is a substantial need to perform studies to evaluate crestal bone loss (CBL) and implant success when using a newly introduced low-speed drilling protocol. Therefore, this study aimed to evaluate the mean CBL and implant success rate by placing implants utilizing two drilling protocols, ie, standard and low-speed drilling protocols.

MATERIALS AND METHODS: A randomized controlled clinical trial was carried out in patients who required dental implants to restore their esthetics and function. The patients were recruited from a university hospital (Academic Centre for Dentistry Amsterdam [ACTA], the Netherlands). Based on the inclusion criteria, patients were randomized to two study groups: (1) control group, standard drilling protocol; and (2) test group, low-speed drilling protocol without saline irrigation. The mean CBL and the implant success rate were evaluated after 12 months of implant placement.

RESULTS: Twenty-three patients (15 men and 8 women with a mean age of 57.5 ± 10.7 years) contributed to the study. Forty Camlog screw-line implants were placed (20 implants per study group). After 12 months of implant placement, the mean CBL of implants placed with the standard protocol and the low-speed protocol was 0.206 ± 0.251 mm and 0.196 ± 0.178 mm, respectively. No statistically significant difference could be recorded among both groups (P = .885). Concerning implants placed in the maxilla, the standard drilling group and low-speed drilling group showed a mean CBL of 0.252 ± 0.175 mm and 0.251 ± 0.175 mm, respectively, compared with 0.173 ± 0.210 mm and 0.141 ± 0.172 mm in the mandible, with no significant difference. The success rate of dental implants at 12 months was 95% in the control group and 90% in the test group.

CONCLUSION: Within the limitations of this study, it can be concluded that implants placed with the low-speed drilling protocol without saline irrigation exhibited a similar CBL compared with implants placed with the standard drilling protocol. However, a higher success rate was recorded especially in type 1-quality bone for the control group compared with the test group. Further randomized clinical trials with greater sample sizes and extended follow-up times should be performed to obtain stronger evidence and a better understanding of the influence of drilling speed on mean CBL and long-term implant success.

PMID:34919621 | DOI:10.11607/jomi.9029

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):1211-1218. doi: 10.11607/jomi.8103.

ABSTRACT

PURPOSE: Cone beam computed tomography (CBCT) is considered both reliable and safe and provides reproducible results in guided dental implant planning procedures. However, it has weaknesses in soft tissue contrast and is associated with radiation exposure. Recent studies showed promising results with magnetic resonance imaging (MRI) as a possible noninvasive, radiation-free, alternative imaging modality for dental indications. The purpose of this study was to evaluate the quality of 1.5 T MRI with a dedicated dental signal-amplification coil in comparison to CBCT for dental implant planning procedures.

MATERIALS AND METHODS: Sixteen subjects undergoing preoperative MRI (3D HR T1w TSE and 3D HR T1w FFE) and CBCT were included in this prospective study. All imaging data were used for dental implant planning procedures using commercially available software. Two experts scored the planning as “ideal,” “improvable,” or “unacceptable.” Furthermore, quantitative distances according to EuCC recommendations were collected. Finally, discrepancies between CBCT and 3D HR T1w TSE were analyzed. Statistical analysis was performed using the Mann-Whitney U test and analysis of variance (ANOVA).

RESULTS: The dental implant planning procedure was technically feasibly using all imaging data. CBCT allowed for “ideal” placement in all cases. Ratings for 3D HR T1w TSE and 3D HR T1w FFE were 81.9%, 18.1%, and 0% and 54.2%, 30.0%, and 15.3% for ideal, improvable, and unacceptable, respectively, identifying 3D HR T1w TSE as superior compared with 3D HR T1w FFE. Head-to-head comparison between CBCT and 3D HR T1w TSE revealed no significant differences regarding the apical position of the implant of 1.2 ± 0.7 mm and 1.3 ± 0.5 mm coronally, respectively (P = .287). The deviation of the planed angle was 3.0 ± 1.2 degrees. In these merged data sets, the distance to the mandibular canal was significantly higher with 1.3 ± 0.8 mm, indicating better utilization of the existing bone.

CONCLUSION: Within the limits of this pilot study, it can be reported that the dental image planning procedure is feasible using 1.5 T MRI with a dedicated dental coil and specific MRI sequences.

PMID:34919623 | DOI:10.11607/jomi.8103

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):1173-1179. doi: 10.11607/jomi.8437.

ABSTRACT

PURPOSE: To compare the primary and secondary stability of conventional (≥ 8-mm) and extrashort (4-mm) implants in edentulous patients using different methods of assessment.

MATERIALS AND METHODS: Patients underwent implant surgery and were randomly allocated into two groups: test, with two conventional implants in the anterior region and two extrashort (4-mm) implants in the posterior region; and control, with two conventional (≥ 8-mm) implants in the anterior region only. Primary stability (S1-implant placement) was assessed by insertion torque, implant stability quotient (ISQ, Osstell), and damping capacity (PTV, Periotest), while secondary stability (S2²¹-21 days after S1; and S2^clip-at prosthetic loading, ± 3 months after S1) was evaluated by ISQ and PTV. The statistical significance level was set at P < .05.

RESULTS: Fifty conventional implants and 24 extrashort implants were placed in 25 patients. The overall survival rate was 97.3%. There was no statistically significant difference between the insertion torque of conventional and extrashort implants (P > .05). PTV values were significantly lower for conventional implants only at S2^clip (P = .041). ISQ values were significantly greater for conventional implants at S1 (P = .004), whereas at S2²¹ and S2^clip, no differences were found (P = .413 and P = .490, respectively). Damping capacity showed no significant differences between S1-S2M²¹ and S1-S2^clip. ISQ values showed a significant increase of stability between S1-S2^clip, for conventional (P = .022) and extrashort (P = .005) implants, which was different from that observed between S1-S2²¹. There was a moderate negative correlation between the PTV and ISQ variables (r = 0.5) of extrashort implants, and between the PTV and insertion torque (r = -0.3) of conventional implants. For extrashort implants, there was a null correlation between ISQ and torque (r = 0.0). There was a moderately positive correlation between ISQ and torque (r = 0.3) in the conventional implant group.

CONCLUSION: The results suggest that extrashort and conventional implants present similar primary and secondary stability values and may similarly influence restorative protocols.

PMID:34919618 | DOI:10.11607/jomi.8437

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):1188-1197. doi: 10.11607/jomi.8994.

ABSTRACT

PURPOSE: This study investigated the impact of 0.12% chlorhexidine gluconate mouthwash on dental implants with periimplant mucositis and contralateral teeth with gingivitis at 6 months of follow-up after nonsurgical treatment.

MATERIALS AND METHODS: This was a secondary analysis of data from a previous controlled, randomized, double-blinded clinical trial of 30 patients diagnosed with peri-implant mucositis and gingivitis in contralateral teeth, at 6 months following treatment. Patients were randomly assigned into a test group (basic periodontal therapy + 0.12% chlorhexidine mouthwash) or a control group (basic periodontal therapy + placebo). Therapy consisted of an adaptation of the full-mouth scaling and root planing protocol. The clinical parameters of visible Plaque Index, Gingival Bleeding Index, probing depth, bleeding on probing, keratinized mucosa width, and gingival and peri-implant phenotype were evaluated at baseline and at 1, 3, and 6 months posttherapy. Data were analyzed using Poisson multilevel regression analysis with a significance level of .05.

RESULTS: The study analyzed 47 implants and contralateral teeth (376 sites) in the test group and 49 implants and contralateral teeth (392 sites) in the control group. No differences were found between the groups at the patient level. At the site level, the teeth and implants presented statistical differences in bleeding on probing, probing depth, and keratinized mucosa width at 3 months for both treatment groups. However, no difference was observed in bleeding on probing in the test group (P = .484) at 6 months, whereas the control group demonstrated increased bleeding on probing (indicating more inflammation) at implant sites than at teeth sites (P = .039). Additionally, implant sites with a thin peri-implant phenotype (P < .001) and located posteriorly (P = .002) presented greater inflammation.

CONCLUSION: Use of a 0.12% chlorhexidine mouthwash for 14 days was beneficial for implant sites with peri-implant mucositis, compared to contralateral teeth sites with gingivitis, as indicated by the reduced percentage of teeth with bleeding on probing.

PMID:34919620 | DOI:10.11607/jomi.8994

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):1159-1164. doi: 10.11607/jomi.8947.

ABSTRACT

PURPOSE: This study was conducted to compare the radiographic, esthetic, and patient-reported outcome measures (PROMs) between immediate and delayed restorations of immediately placed single implants in the maxillary esthetic zone.

MATERIALS AND METHODS: Forty patients with immediate single dental implants in the anterior maxilla were included in this study. Afterward, they were allocated either for immediate restoration with a provisional restoration (IR: 20 patients) or for a delayed restoration (DR: 20 patients). The evaluations were performed after 1 year of follow-up.

RESULTS: No implant and prosthetic failures were observed during the 1-year follow-up. Two minor complications were found in two IR patients; however, no complication was reported in the DR group during the 1 year. Nevertheless, this difference was not statistically significant (P > .05). After 1 year, the mean marginal bone level changes (MBL) were 0.47 ± 0.29 mm and 0.54 ± 0.21 mm for IR and DR, respectively. There was no statistically significant difference between the two groups in terms of MBL (P = .3). Notably, the mean total pink esthetic score (PES) and white esthetic score (WES) after 1 year of follow-up were 11.2 ± 1.1 (PES) and 8 ± 1.02 (WES) for the immediate restoration, and 10.2 ± 0.97 (PES) and 7.65 ± 1.20 (WES) for the delayed restoration. Also, no statistically significant difference was found between IR and DR in terms of esthetic scores (P > .05). The patient satisfaction of these two groups had no statistically significant difference, except for the esthetic factor (P = .04).

CONCLUSION: The immediate restoration and preferred esthetic satisfaction had similar outcomes compared with the delayed restoration.

PMID:34919616 | DOI:10.11607/jomi.8947

Int J Oral Maxillofac Implants. 2021 Nov-Dec;36(6):e159-e165. doi: 10.11607/jomi.8929.

ABSTRACT

PURPOSE: Conscious sedation in oral surgical procedures provides comfort both for patients and practitioners. Midazolam is a sedative agent commonly used in this manner. Dexmedetomidine is also a decent sedative agent, with its analgesic and mild respiratory effects, which is usually preferred in intensive care units. Dexmedetomidine has been recently used in dental surgeries. This study aimed to investigate the analgesic and respiratory properties of midazolam and dexmedetomidine in conscious sedation during dental implant procedures and to compare these two drugs in terms of ease of use and comfort of dental implant operation.

MATERIALS AND METHODS: This study was a prospective double-blind randomized controlled study. The patients who needed dental implant placement were divided into two randomized groups for either midazolam or dexmedetomidine. The amount of sedative agent used, duration of the procedure, onset of sedation, use of additional same sedative agent, and occurrence of desaturation were recorded. Hemodynamic and respiratory variables (mean blood pressure, heart rate, oxygen saturation, and respiratory rate) were recorded every 10 minutes, starting immediately before the loading dose until the end of the procedure. Patients completed a Likert scale for their satisfaction, and patient pain was scored using the numeric rating scale postoperatively. The amount of painkiller usage was recorded and reported. All surgical procedures were performed by the same surgeon, and all recordings were taken by an anesthesiology technician; both were blinded for the randomization. Descriptive and bivariate statistics were computed, and the P value was set at < .05.

RESULTS: This study included patients who were scheduled for two to five dental implant insertions to either arch under conscious sedation. A total of 163 dental implants were inserted into 43 patients. Patients receiving dexmedetomidine had lower pain, higher satisfaction with the procedure, and less desaturation (P = .002). The onset of sedation was more rapid with midazolam (P = .001). The number of implants according to drugs did not differ statistically. On the other hand, the mean operation time was 52.09 ± 20.12 minutes in the dexmedetomidine group and 87.14 ± 26.15 minutes in the midazolam group (P = .001). No significant difference was found for retrograde amnesia and preference of sedative between midazolam and dexmedetomidine.

CONCLUSION: Dexmedetomidine is a good alternative to midazolam for conscious sedation during dental implant procedures, with its better analgesic property and minimal respiratory side effects.

PMID:34919613 | DOI:10.11607/jomi.8929

Rev Med Inst Mex Seguro Soc. 2021 Sep 1;59(5):417-422.

ABSTRACT

BACKGROUND: Since the first cases of human immunodeficiency virus (HIV), ocular manifestations secondary to infection have been known and these have been related to the CD4+ lymphocyte count.

OBJECTIVE: To describe the correlation between ocular manifestations in patients with HIV and the CD4+ lymphocyte count.

MATERIAL AND METHODS: Analytical cross-sectional study of patients with HIV whose CD4+ count was correlated with the presence of ophthalmological manifestations.

RESULTS: 21 patients between 26 and 67 years were studied. Only 3 patients were not on antiretroviral therapy. 67% of the patients presented some type of ocular manifestation, 42% presented non-infection related manifestations, 47% related manifestations and 24% both. Conjunctival microangiopathy was the most frequent ocular manifestation (35.7%). There was a statistically significant correlation (r = 0.76, p = 0.0001) between eye manifestations related to infection and CD4+ lymphocyte count.

CONCLUSIONS: Patients with HIV frequently present ocular manifestations, the majority related to infection; there is a correlation between the presence of these with the CD4+ count. However, a similar number of manifestations not related to infection occurred without correlation with the count; therefore, HIV patients should have periodic ophthalmological examinations, independently of CD4+ count.

PMID:34918893