UNASSIGNED: the present study aimed to establish an epidemiological profile of patients consulting the unit of maxillofacial prosthodontics in Rabat. Results deriving from this study will help enhance the quality of patient care in our center and can also serve as a comparison tool with other maxillofacial teams around the world.
UNASSIGNED: during 11 months all patients consulting the unit of maxillofacial prosthodontics in our center were included. We opted for a questionnaire with 3 variables: socio-demographics, clinical examination data, and the type of prosthetic treatment adopted. The study was conducted in the Department of Removable Prosthodontics in the Center of Consultation and Dental Treatment of Rabat Morocco (CCDTR) from September 2020 to July 2021.
UNASSIGNED: the study population consisted of 91 patients, with a majority of male patients at 53% (n=48). During our study period, the proportion of patients under one-year-old was predominant, accounting for 38.4% (n=35) of the total sample. Among the patients in the sample, 72.5% (n=66) had no profession, while 66% (n=60) had a low income. Regarding medical insurance, the majority of our patients, 85.5% (n=78), were covered by Public Health Insurance for the Low-income Population (PHILP). Among the total sample, 57.1% (n=52) consulted for a combination of pain function and aesthetics. Additionally, 61.5% (n=56) were referred by teaching hospitals. For the type of oro-facial defect, 52.7% (n=48) of the sample consisted of newborns with congenital facial cleft. Out of the 91 patients, 36 had maxillofacial tumors, with 47.6% (n=17) of them presenting squamous cell carcinoma. Furthermore, 63.7% (n=58) of the prosthetic treatments adopted involved presurgical orthopedic treatments for newborns with facial cleft.
UNASSIGNED: the study on the epidemiological profile of patients attending the maxillofacial prosthodontics unit at Ibn Sina University Hospital in Rabat, Morocco provides important insights. The findings highlight the predominance of male patients and the prevalence of oro-facial defects in newborns. Socioeconomic factors, such as low income and lack of profession, are significant considerations. The majority of patients are covered by the PHILP, indicating the importance of medical insurance. These findings contribute to improving healthcare planning and specialized care for this patient population.

UNASSIGNED: The purpose of this comparative study in vitro was to evaluate the effect of organic and inorganic nanoparticles on colour stability, tear strength and hardness of maxillofacial silicone elastomer at baseline and when subjected to outdoor weathering for 6 months.
UNASSIGNED: A total of 240 specimens were fabricated using M511 platinum silicone which were divided into total 4 groups (n = 60) based on the type of nanoparticles (control, polytetrafuoroethylene [PTFE], titanium dioxide [TiO2], zinc oxide [ZnO]) added and each group was further divided into 3 subgroups (n = 20) for colour, tear strength (TS) and hardness (H) testing. The tests were conducted and data was obtained both before and after outdoor weathering of 6 months.
UNASSIGNED: Minimum colour change after weathering was observed in PTFE group (∆E = 2.23). TiO2 group showed maximum TS (12.01 N/mm) followed by PTFE group (10.85 N/mm) before weathering. After weathering, maximum TS was shown by TiO2 group (12.9 N/mm) and PTFE group (12.54 N/mm). TiO2 group showed maximum hardness (24.15 shore A) before weathering and PTFE group showed maximum hardness (33.43 shore A) after weathering.
UNASSIGNED: Within the limitations of this study, it can be concluded that the addition of polytetrafuoroethylene nanoparticles to the polymer enhances both the optical as well as mechanical properties and can be considered favourable for the extended life of the prosthesis.

OBJECTIVE: To evaluate in situ the influence of sweat, oil, sunscreen, and disinfectant solution on the color stability, hardness, and roughness of elastomer for facial prostheses.
METHODS: Standardized and intrinsically pigmented specimens remained in contact with human skin from the same person for 30 days, considering exposures (n = 36 per group), absent of exposition (Control, C); sweat and oiliness contact (SO); sweat and oiliness associated with sunscreen (SOS); 0.12% chlorhexidine digluconate immersion (CD0.12%); and all agents exposed (SOSCD). The main variables were color change (CIELab and National Standard Bureau system, NBS), Shore A hardness, and surface roughness, measured at baseline and 30 days. Qualitative analyses were performed by atomic force microscopy (AFM) and scanning electron microscopy (SEM). The data were analyzed by Kruskal-Wallis tests (color) and two-way ANOVA (hardness and roughness) with Sidak post-test (α = 0.05).
RESULTS: CD0.12% (1.54 ± 0.49) and SOSCD (2.10 ± 1.03) had similar effects and caused the smallest color changes, considered mild and noticeable (NBS), respectively. SOS promoted the greatest color change (6.99 ± 1.43, NBS: large) and hardness (17.97 ± 0.56); SOS promoted intermediate roughness (3.48 ± 1.05) between SOSCD (2.25 ± 0.53), and two similar groups: C (4.46 ± 0.95), and CD0.12% (4.39 ± 1.26). The qualitative analysis showed an irregular, dense, dry, and whitish layer on the surface of the specimens exposed to sunscreen, which was reduced when in contact with 0.12% chlorhexidine digluconate.
CONCLUSIONS: Endogenous and exogenous factors are capable of altering elastomer properties. The 0.12% chlorhexidine digluconate minimized the changes caused by sweat, oil, and sunscreen.

BACKGROUND: Facial prostheses can have a profound impact on patients\' appearance, function and quality of life. There has been increasing interest in the digital manufacturing of facial prostheses which may offer many benefits to patients and healthcare services compared with conventional manufacturing processes. Most facial prosthesis research has adopted observational study designs with very few randomised controlled trials (RCTs) documented. There is a clear need for a well-designed RCT to compare the clinical and cost-effectiveness of digitally manufactured facial prostheses versus conventionally manufactured facial prostheses. This study protocol describes the planned conduct of a feasibility RCT which aims to address this knowledge gap and determine whether it is feasible to conduct a future definitive RCT.
METHODS: The IMPRESSeD study is a multi-centre, 2-arm, crossover, feasibility RCT with early health technology assessment and qualitative research. Up to 30 participants with acquired orbital or nasal defects will be recruited from the Maxillofacial Prosthetic Departments of participating NHS hospitals. All trial participants will receive 2 new facial prostheses manufactured using digital and conventional manufacturing methods. The order of receiving the facial prostheses will be allocated centrally using minimisation. The 2 prostheses will be made in tandem and marked with a colour label to mask the manufacturing method to the participants. Participants will be reviewed 4 weeks following the delivery of the first prosthesis and 4 weeks following the delivery of the second prosthesis. Primary feasibility outcomes include eligibility, recruitment, conversion, and attrition rates. Data will also be collected on patient preference, quality of life and resource use from the healthcare perspective. A qualitative sub-study will evaluate patients\' perception, lived experience and preference of the different manufacturing methods.
CONCLUSIONS: There is uncertainty regarding the best method of manufacturing facial prostheses in terms of clinical effectiveness, cost-effectiveness and patient acceptability. There is a need for a well-designed RCT to compare digital and conventional manufacturing of facial prostheses to better inform clinical practice. The feasibility study will evaluate key parameters needed to design a definitive trial and will incorporate early health technology assessment and a qualitative sub-study to identify the potential benefits of further research.
BACKGROUND: ISRCTN ISRCTN10516986). Prospectively registered on 08 June 2021,  https://www.isrctn.com/ISRCTN10516986 .

There are often bonding problems between acrylic resins and silicone. PEEK (polyetheretherketone), which is a high-performance polymer, has great potential for the implant, and fixed or removable prosthodontics. The aim of this study was to evaluate the effect of different surface treatments on PEEK to be bonded to maxillofacial silicone elastomers. A total of 48 specimens were fabricated from either PEEK or PMMA (Polymethylmethacrylate) (n = 8). PMMA specimens acted as a positive control group. PEEK specimens were divided into five study groups as surface treatments as control PEEK, silica-coating, plasma etching, grinding, or nano-second fiber laser. Surface topographies were evaluated by scanning electron microscopy (SEM). A platinum-primer was used on top of all specimens including control groups prior to silicone polymerization. The peel bond strength of the specimens to a platinum-type silicone elastomer was tested at a cross-head speed of 5 mm/min. The data were statistically analyzed (α = 0.05). The control PEEK group showed the highest bond strength (p < 0.05) among the groups. No statistical difference was found between control PEEK, grinding, or plasma etching groups (p > 0.05). The lowest bond strength was seen in the laser group, which was not statistically different from silica-coating (p > 0.05), and statistically different from control PEEK, grinding, or plasma groups (p < 0.05). Positive control PMMA specimens had statistically lower bond strength than either control PEEK or plasma etching groups (p < 0.05). All specimens exhibited adhesive failure after a peel test. The study results indicate that PEEK could serve as a potential alternative substructure for implant-retained silicone prostheses.

OBJECTIVE: Digital technologies are continuously improving the accuracy and quality of maxillofacial prosthetics, but their impact on patients remains unclear. This cross-sectional study aimed to analyze the impact of facial prosthetics service provision, patients\' perception, and digital technology on prostheses construction.
METHODS: All patients who presented for evaluation and management of facial defects between January 2021 and December 2021 at the ENT clinic were eligible for study enrollment. Patients requiring prosthetic reconstruction of their missing facial parts were included in the study. Forty-five questionnaires were delivered, inquiring about the patients\' prosthetic demographics, prosthesis manufacture using 3D technologies, and their perceptions and attitudes.
RESULTS: A total of 37 patients responded (29 males, eight females; mean age 20.50 years). The congenital cause was the highest among other causes (p = 0.001) with auricular defects being the highest (p = 0.001). A total of 38 prostheses were constructed and 17 prostheses were retained by 36 craniofacial implants (p = 0.014). The auricular and orbital implants success rates were 97% and 25%, respectively. The implant locations were digitally planned pre-operatively. Digital 3D technologies of defect capture, data designing, and 3D modeling were used and perceived as helpful and comfortable (p = 0.001). Patients perceived their prosthesis as easy to handle, suited them, and they felt confident with it (p = 0.001). They wore it for more than 12 h daily (p = 0.001). They were not worried that it would be noticed, and found it comfortable and stable during various activities (p = 0.001). Implant-retained prosthesis patients were more satisfied with it, and found it easy to handle and stable (p = 0.001).
CONCLUSIONS: Congenital defects are the main cause of facial defects in the study country. The overall acceptance of maxillofacial prostheses was good, showing high patient perception and satisfaction. Ocular and implant-retained silicone prostheses are better handled, more stable, and the latter is more satisfying than traditional adhesive prostheses. Digital technologies save time and effort invested in manufacturing facial prostheses.

The effect of a novel nano-ceramic coating (TiO2) using an atomic layer deposition (ALD) technique on the surface of polymethyl methacrylate (PMMA) material was investigated. The patients\' and clinicians\' perception and acceptance of the PMMA color with TiO2 coating were also examined. In vitro color measurement was performed on thirty specimens (light, original, and dark pink) before and after TiO2 coating. Patients\' and clinicians\' perception and acceptance of color changes on PMMA were measured and compared. Descriptive and analytic statistics were analyzed (a = 0.05). TiO2 films were successfully deposited on the PMMA specimen by the ALD technique. Color changes after TiO2 coating were observed on all three PMMA shades, significantly higher than the established 50:50% perceptibility threshold, but below the established 50:50% acceptability threshold. The percentage of patients that perceived a color difference after TiO2 coating were 83.3%, 63.9%, and 77.8% for light, original, and dark pink, respectively. The percentages of clinicians that were satisfied with the color difference were 96.4%, 80%, and 69.2% for light, original, and dark pink, respectively. Color changes after TiO2 coating were observed, but below the acceptable threshold. The clinical survey demonstrated that a color difference was perceived but was clinically acceptable. In general, laypeople have lower perception and higher acceptance of changes in PMMA color than clinicians.

OBJECTIVE: To assess the effect of preoperative oral clindamycin in reducing early implant failure in healthy adults undergoing conventional implant placement.
METHODS: We conducted a prospective, randomised, double-blind, placebo-controlled clinical trial in accordance with the ethical principles and Consolidated Standards of Reporting Trials statement. We included healthy adults who underwent a single oral implant without previous infection of the surgical bed or the need for bone grafting. They were randomly treated with a single dose of oral clindamycin (600 mg) 1 h before surgery or a placebo. All surgical procedures were performed by one surgeon. A single trained observer evaluated all patients on postoperative days 1, 7, 14, 28, and 56. Early dental implant failure was defined as the loss or removal of an implant for any reason. We recorded the clinical, radiological, and surgical variables, adverse events, and postoperative complications. The study outcomes were statistically analysed to evaluate differences between the groups. Furthermore, we calculated the number required to treat or harm (NNT/NNH).
RESULTS: Both the control group and clindamycin group had 31 patients each. Two implant failures occurred in the clindamycin group (NNH = 15, p = 0.246). Three patients had postoperative infections, namely two placebo-treated and one clindamycin-treated, which failed (relative risk: 0.5, CI: 0.05-5.23, absolute risk reduction = 0.03, confidence interval: - 0.07-0.13, NNT = 31, CI: 7.2-∞, and p = 0.5). One clindamycin-treated patient experienced gastrointestinal disturbances and diarrhoea.
CONCLUSIONS: Preoperative clindamycin administration during oral implant surgery in healthy adults may not reduce implant failure or post-surgical-complications.
CONCLUSIONS: Oral clindamycin is not efficacy.
BACKGROUND: The present trial was registered (EudraCT number: 2017-002,168-42). It was approved by the Committee for the Ethics of Research with Medicines of Euskadi (CEIm-E) on 31 October 2018 (internal code number: 201862) and the Spanish Agency of Medicines and Medical Devices (AEMPS) on 18 December 2018.

BACKGROUND: Soft palate defects created during oral cancer surgery may prevent complete palatal closure and trigger palatopharyngeal insufficiency. One current treatment employs a rigid obturator prosthesis; an extension of acrylic resin at the level of the hard palate ensures surface contact with the remaining musculature. Unfortunately, airflow escape often causes hypernasality, compromises speech intelligibility, and creates swallowing problems (including leakage of food and fluid into the nasal airway). We plan to test a new removable denture featuring a thick dental dam that serves as a membrane obturator. The principal objective of the clinical trial is a comparison of speech handicap levels after 1 month in patients with acquired velar insufficiencies who wear either the new device or a conventional, rigid obturator. The secondary objectives are between-device comparisons of the swallowing handicaps and the health-related qualities of life.
METHODS: The VELOMEMBRANE trial is a superiority, open-labeled, two-way, random crossover clinical trial. Adult patients exhibiting velar or palatovelar substance loss after tumor excision and who are indicated for rigid obturator-mediated prosthetic rehabilitation will be recruited in two teaching hospitals in France. Fourteen participants will be randomly allocated to wear both prostheses for 1-month periods in either order. The new membrane obturator is a removable resin prosthesis incorporating a rigid extension that holds a dental dam to restore the soft palate. The primary outcome will be the extent of phonation-related disability (the overall score on the Voice Handicap Index [VHI]). The secondary outcomes will be the Deglutition Handicap Index and health-related quality of life scores of the European Organization for Research and Treatment of Cancer (EORTC).
CONCLUSIONS: High-quality evidence will be provided to document the utility of a new medical device that may greatly improve the management and quality of life of patients with acquired velar insufficiency.
BACKGROUND: ClinicalTrials.gov NCT04009811 . Registered on 4 July 2019.

BACKGROUND: Resistance to long-term color change is a desirable property for facial prosthetic elastomers. Evidence for the color stability of maxillofacial silicones under aging and hot and humid Indian weathering conditions is lacking.
OBJECTIVE: The purpose of this in vitro study was to evaluate the effect of adding opacifiers on the color stability of maxillofacial silicone under human aging and Indian weather conditions.
METHODS: A total of 93 specimen disks were obtained from the A-2186, platinum-based, room-temperature vulcanized, maxillofacial silicone elastomer by using a Ø30×6-mm stainless-steel die. The specimens were divided into 3 main groups (n=30), C (control), T (titanium dioxide), and B (barium sulfate), and 1 additional specimen (n=1) from each group was stored in a closed box and further subgrouped as outdoor weathering (COut, TOut, BOut), acidic perspiration (CAcid, TAcid, BAcid), sebum (CSebum, TSebum, BSebum) (n=10), and visual comparison (CVis, TVis, BVis) (n=1). Baseline L∗, a∗, b∗ values were recorded by using a spectrophotometer and visual perception. The specimens were subjected to human and extraoral aging conditions, and the values were recorded again after 6 months. Data were analyzed statistically by using analysis of variance (ANOVA) and post hoc analysis with the Tukey post hoc test.
RESULTS: In group C, the mean color change for COut was 3.69 ±0.49; CAcid, 3.58 ±0.68; and CSebum, 7.53 ±0.22 (P<.001). In group T, the mean color change for TOut was 2.60 ±0.24; TAcid, 2.35 ±0.13; and TSebum, 4.91 ±0.44 (P<.001). In group B, BOut was 1.59 ±0.28, BAcid was 1.46 ±0.28, and BSebum was 4.03 ±0.71 (P<.001). The specimens containing barium sulfate showed the maximum color stability. The least color stability was observed in all specimens exposed to sebum solution and was significantly different (P<.001) from the outdoor weather and acidic perspiration specimens. Visually perceivable color changes were observed in specimens exposed to the sebum solution.
CONCLUSIONS: The addition of titanium dioxide and barium sulfate as opacifiers resulted in clinically acceptable color change when exposed to outdoor weathering and acidic perspiration but not in sebum solution.