A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Combination of CAD/CAM technologies and conventional processing in the fabrication of a maxillary obturator prosthesis: a clinical report.

Soft and hard tissue defects resulting from resective surgeries for carcinomas located in the maxillary arches can cause functional, esthetic, and psychological damage. A removable obturator prosthesis offers several advantages, restoring oral functions and improving patients' quality of life. Technological advancements, such as the use of intraoral scanning and computer-aided design (CAD) and manufacturing, reduce laboratory working time, eliminate the risk of impression material aspiration, and address challenges related to whole tissue undercut impression. Here, we report the case of a partially edentulous female patient with a velo-palatal defect for whom a rigid maxillary obturator prosthesis was fabricated. Digital impressions were taken and the standard tessellation language files of the scans were sent to the laboratory. Using dental CAD software, the maxillary metallic framework was designed and manufactured using selective laser melting technology. The obturators and artificial teeth were conventionally processed, with acrylic resin used for the rigid obturators. The resulting obturator prosthesis made it possible to close the oro-nasal communication and to improve swallowing, speaking, and chewing.

Dental Versus Zygomatic Implants in the Treatment of Maxillectomy: A Finite Element Analysis.

This study analyzed the stress distributions on zygomatic and dental implants placed in the zygomatic bone, supporting bones, and superstructures under occlusal loads after maxillary reconstruction with obturator prostheses. A total of 12 scenarios of 3-dimensional finite element models were constructed based on computerized tomography scans of a hemimaxillectomy patient. Two obturator prostheses were analyzed for each model. A total force of 600 N was applied from the palatal to buccal bones at an angle of 45°. The maximum and minimum principal stress values for bone and von Mises stress values for dental implants and prostheses were calculated. When zygomatic implants were applied to the defect area, the maximum principal stresses were similar in intensity to the other models; however, the minimum principal stress values were higher than in scenarios without zygomatic implants. In models that used zygomatic implants in the defect area, von Mises stress levels were significantly higher in zygomatic implants than in dental implants. In scenarios where the prosthesis was supported by tissue in the nondefect area, the maximum and minimum principal stress values on cortical bone were higher than in scenarios where implants were applied to defect and nondefect areas. In patients who lack an alveolar crest after maxillectomy, a custom bar-retained prosthesis placed on the dental implant should reduce stress on the zygomatic bone. The stress was higher on zygomatic implants without alveolar crest support than on dental implants.

Prosthetic rehabilitation of patients with maxillary oncology defects using zygomatic implants.

PURPOSE: Prosthetics for patients after oncological resection of the upper jaw is a complex problem associated with the physiological and anatomical separation of the oral cavity and the nasal/paranasal region. This study reports the clinical results of the use of the zygomatic implants for prosthetic rehabilitation in patients with maxillectomy due to upper jaw tumors. MATERIALS AND METHODS: The study included 16 patients who underwent prosthetic rehabilitation using a zygomatic implant after maxillectomy period from 2021 to 2023. After the tumor was removed, immediate surgical obturators were placed. Main prosthetic rehabilitation was performed 6-12 months after tumor removal, but before that, a temporary obturator was made and used. Six-twelve months after tumor resection, 1-4 zygomatic implants were inserted into the zygomatic bone unilaterally or bilaterally. A total of 42 zygomatic implants were installed, 2 of which were unsuccessful and were removed in 1 patient. The implants were placed using the surgical guide, which was planned and prepared digitally. RESULTS: No postsurgical complications were seen, and the patients were discharged from the hospital after 7-10 days. The patients were able to return to a normal diet (hard food) after just 7 days following surgery, with no further complaints regarding function or pain, apart from the residual edema caused by the intervention. CONCLUSIONS: The use of prostheses fixed on zygomatic implants in patients with maxillary defects is an effective method of prosthodontic rehabilitation in complex clinical cases after maxillectomy.

Tratamento reabilitador com prótese obturadora em paciente acometido por maxilectomia parcial: relato de caso / Rehabilitative treatment with obturator prosthesis in a patient suffering from partial maxillectomy: case report

Introdução: O tratamento de tumores malignos ou benignos, podem resultar em procedimentos cirúrgicos, como a maxilectomia parcial ou total, gerando comunicação bucosinusal nos pacientes. Uma forma de resolver estas alterações maxilofaciais é através do tratamento reabilitador com próteses obturadoras a fim de restabelecer a função mastigatória, estética, fonética e psicológica. Objetivo: o objetivo deste trabalho foi relatar o caso clínico de um paciente oncológico que foi reabilitado com prótese obturadora devido à maxilectomia por neoplasia maligna de seio maxilar. Relato de caso: Paciente de 62 anos, sexo masculino, procurou atendimento odontológico no Centro de Oncologia Bucal da Universidade Estadual Paulista "Júlio de Mesquita Filho" (UNESP) de Araçatuba ­ SP após a realização de uma maxilectomia parcial com comunicação bucosinusal e foi encaminhado para o Curso de Especialização em Prótese Dentária da Faculdade de Odontologia ­ Unesp/Araçatuba-SP para a reabilitação. Foi proposto, primeiramente a realização da prótese obturadora para fechar a comunicação bucosinusal e uma prótese total inferior para o arco antagonista e, posteriormente, a realização de uma prótese facial. Conclusão: O tratamento reabilitador com próteses obturadoras possui um bom resultado estético e funcional, favorecendo uma melhor função mastigatória e fonética, e melhorando consideravelmente a condição psicológica que é muito afetada nos pacientes submetidos a maxilectomia total ou parcial, sendo necessário uma boa interação com toda a equipe multiprofissional envolvida para que haja um melhor tratamento integrado para a reabilitação e melhora da qualidade de vida(AU)

Introduction: The treatment of malignant or benign tumors can result in surgical procedures, such as partial or total maxillectomy, generating oral communication in patients. One way to resolve these maxillofacial changes is through rehabilitative treatment with obturator prostheses in order to reestablish masticatory, aesthetic, phonetic and psychological function. Objective: the objective of this work was to report the clinical case of a cancer patient who was rehabilitated with an obturator prosthesis due to maxillectomy for malignant neoplasia of the maxillary sinus. Case report: A 62-year-old male patient sought dental care at the Oral Oncology Center of the Universidade Estadual Paulista "Júlio de Mesquita Filho" (UNESP) in Araçatuba ­ SP after undergoing a partial maxillectomy with oral cavity and was referred for the Specialization Course in Dental Prosthesis at the Faculty of Dentistry ­ Unesp/Araçatuba-SP for rehabilitation. It was proposed, firstly, to create an obturator prosthesis to close the bucosinusal communication and a total lower prosthesis for the antagonistic arch and, later, to create a facial prosthesis. Conclusion: Rehabilitative treatment with obturator prostheses has a good aesthetic and functional result, favoring better chewing and phonetic function, and considerably improving the psychological condition that is greatly affected in patients undergoing total or partial maxillectomy, requiring good interaction with the entire the multidisciplinary team involved so that there is better integrated treatment for rehabilitation and improved quality of life

Quality of life in oncologic patients after maxillectomy operations: clinical case series on different rehabilitation protocols.

OBJECTIVE: The study's purpose was to compare the quality of life (QoL) in oncologic patients treated with different rehabilitation protocols following maxillary tumor resections. PATIENTS AND METHODS: The patients were divided into three groups. Group A: 18 Patients with maxillary obturator prosthesis. Group B: 17 Patients with simultaneous autologous tissue reconstruction. Group C: 12 Patients with prosthesis on zygomatic implants. The post-operative QoL was compared using standard questionnaires, investigating items like pain, mood, social relations, and specific functions that could potentially compromise the post-operative QoL. A secondary analysis compared reconstructed vs. non-reconstructed patients. RESULTS: Most questionnaire items did not show significant differences among groups. Statistically significant outcomes were found in two parameters (social contact and sexuality), in which patients treated with zygomatic implants had the best satisfaction, and patients with obturator prostheses showed the lowest satisfaction. Patients belonging to the non-reconstructed group showed better moods than those in the reconstructed group, while taste problem complaints and pain were lower in the reconstructed group. CONCLUSIONS: Although the type of reconstruction procedure depends on the type of maxillectomy to be performed and on the general health situation of each patient, the impact of the rehabilitation protocol on the patients' QoL should be accounted for when planning the treatment.

Nasolabial morphological changes in patients with unilateral cleft lip and palate using a Korat-modified nasoalveolar moulding appliance with primary correction.

OBJECTIVE: The objective of this study is to measure the morphological changes of the nose and lip in patients with unilateral cleft lip and palate before and after cheiloplasty with primary rhinoplasty (primary correction) in conjunction with Korat-NAM usage. DESIGN: Longitudinal cohort study. SETTING: Cleft Center Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand. SUBJECTS: Twenty-six patients with unilateral cleft lip and palate. INTERVENTIONS: Control group: only active obturator before primary correction. Experimental group: an active obturator and Korat-NAM I before primary correction. A customized endotracheal tube was retained in the nostril for 3 weeks before switching to Korat-NAM II for 1 year. MAIN OUTCOME MEASURES: Six measurements comprising nostril rim length, nostril height, nostril sill width, columella angle, vertical lip height, and horizontal lip length were measured from the patients' photographs. All measurements, except the columella angle, were reported as the cleft side/non-cleft side value ratio. Measurements were taken at the initial appointment, immediately before, 3 weeks after, and 1 year after primary correction. RESULTS: Nostril rim length ratio, nostril height ratio, nostril sill width ratio, columella angle on the cleft side, and vertical lip height ratio were improved using Korat-NAM before and 3 weeks after primary correction. Nostril rim length and height ratios were significantly better than the control group. CONCLUSIONS: Korat-NAM improved nose and lip morphology before primary correction. An overcorrection improved the nose and lip morphology on the cleft side. The nostril rim length and vertical lip height on the cleft side also improved with Korat-NAM II 1 year after primary correction.

Full digital workflow of a 2-piece obturator with polyetherketoneketone in a patient with maxillectomy and trismus: A clinical and laboratory report.

The computer-aided design and computer-assisted manufacturing of a 2-piece definitive palatal obturator 3D printed from polyetherketoneketone and 2 acrylic resins with a fully digital workflow are presented for a patient who was diagnosed with adenoid cystic carcinoma and who developed severely limited mouth opening after surgery and radiotherapy. The 18-month follow-up period revealed satisfactory function, tissue compatibility, retention, and esthetics for this patient with a maxillectomy and severe trismus.

Recommendations for post-rehabilitation care of maxillofacial prostheses

Aim: This study aimed to review the scientific literature to describe the main care and hygiene protocols for different types of maxillofacial prostheses (MFP). Methods: A bibliographic search on the PubMed / Medline database using the following keywords: ["maxillofacial prosthesis" OR "ocular prostheses" OR "palatal obturators"] AND ["Cleaning" OR "disinfection"] AND ["care"] AND ["color stability"] OR ["denture cleansers" OR "cleansing agents"]. Articles addressing materials, cleaning and disinfection protocols, and care related to MFP were included. The following exclusion criteria were applied: no adequate methodology, incompatibility with the area of interest, and unavailability for reading in full. Results: The papers were grouped into the following topics: facial prostheses, ocular prostheses, maxillofacial intraoral prostheses, and retention systems. Conclusion: Despite the MFP changes over time, its degradation decreases upon following the recommendations and post-adaptation care. The guidelines for cleaning and disinfection must be individualized to guarantee the longevity of the prosthesis and the patient health

The Effect of the Wall Thickness of 3D-Printed Obturator Bulbs on Masticatory Function in Patients with Aramany Class I Defects: A Randomized Crossover Clinical Trial.

PURPOSE: To evaluate the effect of obturator bulb thickness on the masticatory performance and weight of obturator prostheses in edentulous hemimaxillectomy patients. MATERIALS AND METHODS: A randomized, single-blind, three-period crossover trial was conducted with 17 edentulous patients. Each patient was provided with three definitive 3D-printed obturator prostheses. Obturators were divided into three groups: group 1 (G1; 1-mm bulb); group 2 (G2; 2-mm bulb); and group 3 (G3; 3-mm bulb). After fabrication, the weight of each obturator was measured with a digital analytical balance. The patients used each obturator for a period of 2 weeks without a passive period (ie, they did not stop using the obturator). The masticatory function of each obturator was evaluated with an adapted Sato questionnaire and the sieve test. Data were analyzed using one-way ANOVA and Pearson correlation analysis (α = .05). RESULTS: According to the results of the Sato questionnaire and sieve test, G1 demonstrated the highest masticatory function scores (70.88 ± 9.39; 1.06 ± 0.06), while G3 exhibited the lowest scores (48.23 ± 7.69; 0.92 ± 0.05; P < .001). The weight of the obturators was significantly different between groups (G1 = 31.58 ± 1.09 g; G2 = 33.99 ± 1.21 g; G3 = 36.57 ± 1.13 g; P < .001). The correlation between masticatory function and the weight of the obturator was significant (P < .05). CONCLUSIONS: This study revealed that 1-mm obturator bulb thickness was an effective fabrication method for improving masticatory function and reducing the weight of obturator prostheses in edentulous hemimaxillectomy patients.

Prosthetic rehabilitation after hemimaxillectomy: a case report.

Maxillofacial defects created by the surgical resection of a tumor negatively impact the mastication, phonation, swallowing, and psychological function of patients. A 68-year-old woman received a diagnosis of oral squamous cell carcinoma involving the hard palate. The hemimaxillectomy procedure for tumor resection created a defect on the left side of the palate. This case report describes the patient's cancer treatment from presurgical planning to final rehabilitation with a conventional obturator and subsequent follow-up care for 1 year. The rehabilitation strategy was satisfactory for the patient, reestablishing lost function and esthetics.

Digital workflow and virtual validation of a 3D-printed definitive hollow obturator for a large palatal defect.

This clinical report describes how a hollow obturator prosthesis was designed and fabricated for an 82-year-old partially edentulous patient with a large palatal defect. Computer-aided design (CAD) was used to design, articulate, and align the mandibular denture with the obturator prosthesis. The prosthesis was printed, adjusted chairside, rescanned, and made hollow by using a CAD software program. The prosthesis was printed in resin with a dental 3D printer. Quantitative evaluations of clinical (prosthesis dimensions, rest, and occlusal vertical dimensions) and virtual (surface area, volume, weight, interpoint mismatches, spatial overlap) parameters found that the 3D-printed prosthesis required an additional 5% chairside modification. The greatest differences in volume (24.7% less) and weight (22.2% less) were observed when the modified obturator bulb was made hollow via CAD. Hollowing the bulb, therefore, reduced the spatial overlap in volume by 16.8%.

Refabrication of an implant-retained obturator using the denture duplication technique in a bilateral maxillectomy patient with a free fibula osteocutaneous flap.

PURPOSE: We aimed to introduce a simple method for refabrication of an implant-retained obturator using the denture duplication technique while retaining the custom abutments for a patient who underwent bilateral maxillectomy and reconstruction with a free fibula osteocutaneous flap. We have proposed this technique to facilitate the impression-making procedure for this extensive maxillary defect and to avoid lengthy and complicated laboratory procedures. METHODS: A custom tray was developed by duplicating the fitting surface of an old obturator using silicone putty. The tray was used for a bite-pressure impression wherein both definitive impression and jaw relation were obtained simultaneously, reducing the time required for the placement of a new obturator. CONCLUSIONS: We used the denture duplication technique to refabricate an implant-retained obturator while retaining the custom abutments. Decreased chairside time, fewer visits, the use of easily available materials, and uncomplicated laboratory procedures make this technique more economical and acceptable for patients. Using this approach, the patient was able to use the old prosthesis until the delivery of the new prosthesis. The replacement obturator that was developed using this method maintained an acceptable level of oral function.

Microbial Analysis of Obturators During Maxillofacial Prosthodontic Treatment Over an 8-Year Period.

The aim of the study was to investigate the microbial colonization (by Candida species, anaerobic and facultative anaerobic bacteria) of maxillary obturators used for the restoration of maxillary defects, including during radiotherapy.Retrospective cohort study.Fifteen patients requiring a maxillary obturator prosthesis had swabs of their obturators and adjacent tissues taken at different stages of their treatment over a period of 8 years.Identification of microbial species from the swabs was carried out using randomly amplified polymorphic DNA polymerase chain reaction (RAPD PCR) analysis, checkerboard DNA-DNA hybridization, CHROMagar Candida chromogenic agar, and DNA sequencing.Candida species were detected in all patients and all patients developed mucositis and candidiasis during radiotherapy which was associated with an increase in colonization of surfaces with Candida spp., particularly C albicans. Microbial colonization increased during radiotherapy and as an obturator aged, and decreased following a reline, delivery of a new prosthesis, or antifungal treatment during radiotherapy.Microbial colonization of maxillary obturators was related to the stage of treatment, age of the obturator material, radiotherapy and antifungal medications, and antifungal treatment may be recommended if C albicans colonization of palatal tissues is greater than 105 colony-forming units per cm2 following the first week of radiotherapy.

Modified vestibuloplasty of the zygomaticoalveolar crest to gain intradefect support for an obturator prosthesis.

This clinical report details a novel surgical modification at the time of maxillectomy to improve obturator function. A vestibuloplasty and split thickness skin graft of the zygomaticoalveolar crest created a denture-bearing surface that, when engaged, provided support and stability for the obturator prosthesis. This report outlines the surgical and prosthodontic procedures and the results achieved.

Rehabilitation of a mid-facial defect using maxillary obturator with a maxillary expansion device and orbital prosthesis.

Midfacial defects are defined as congenital or acquired defects in the horizontal plane at the middle third of the face and communicate with intraoral maxillary defects. These defects lead to speaking difficulty, difficulty in saliva control and deglutition, mastication, and esthetics. Prosthetic rehabilitation of such defects with maxillofacial prosthesis is a challenging task. Maxillary defects with bilateral undercuts present are common. This case report explains to achieve retention by engaging the bilateral undercuts with the desired path of insertion and obtaining adequate retention of these prostheses. This clinical case report presents prosthetic rehabilitation of a mid-facial defect involving one orbit and the premaxilla region with the help of silicone orbital prostheses and magnets along with an expansion device. This dramatically improved the patient's speech, mastication, deglutition, esthetics, and self-confidence.

Intraoral customized Z-spring-retained delayed surgical obturator for rare cases of bilateral subtotal maxillectomy.

While dealing with a grave second wave of ongoing pandemic COVID-19, India also saw a surge in cases of COVID-19-associated mucormycosis, a systematic fungal infection caused by the Mucorales species. Mucormycosis is a highly angioinvasive, rapidly spreading fungal infection. In numerous cases of mucormycosis, bilateral subtotal maxillectomy was performed due to unpredictable and indefinable advancement of fungus clinically. Effective obturation of bilateral maxillectomy defect is a difficult task and as this is a relatively uncommon surgical problem, insufficient data are available on the construction of delayed surgical obturator for such cases. The aim of this article is to discuss the design of Z-spring-retained delayed surgical obturator which is easy to fabricate, easy to rectify, cost-effective, and comfortable for the patients compared to previous spring-retained obturators. This surgical obturator is retained through Z-spring made of 1.02 mm thick wire. Due to the thick gauge, this spring counters postsurgery trismus and develops the seal between the acrylic plate and dorsum of the tongue during deglutition thus helps the patient in taking a soft diet initially. Novelty in this case is the design of the spring, which makes it beneficial for both patient and prosthodontist.

Influence of Apical Diameter on Filling Material Extrusion during Retreatment - A Micro-CT and CBCT evaluation.

AIM: To investigate whether foraminal widening performed at primary treatment has an effect on the amount of apically extruded obturator material during retreatment and to evaluate the sensitivity of cone beam computed tomography (CBCT) in detecting extruded obturator material. METHODS: Forty palatal roots of maxillary molars were selected based on micro-CT and divided into two groups (n=20): with foraminal widening (WE) and without foraminal widening (NE). To standardize the apical foramen, all specimens were instrumented to the foramen using the Protaper Next system, up to instrument X3. The WE group was instrumented to the foramen up to instrument X5, and the NE group was instrumented 1 mm lower. The canals were obturated 1 mm below the apical foramen with gutta-percha and AH Plus and stored for 7 days at 37 °C and 95% humidity. Roots were fixed in microtubes filled with 1.5% agar gel. The obturation material was removed with Reciproc R50. Scans of the teeth and agar were performed using micro-CT and CBCT. Comparison between groups and between methods was performed using Mann-Withney test (p ≤0.05). RESULTS: No statistical difference was found when comparing the extruded material between groups using micro-CT (p = 0.589) or CBCT (p = 0.953). CBCT measured a greater volume of extruded material than micro- CT (p = 0.0004). CONCLUSION: Foraminal widening had no effect on the extrusion of filling material during retreatment. The CBCT favored the evaluation of apically extruded filling material.

Prosthetic management of a postsquamous cell carcinoma patient with maxillomandibular resection including lip.

Maxillofacial defects not only create esthetic and functional problems for the patient but also have psychological and social impact on the patient. The present clinical report describes the management of a patient who had undergone partial maxillectomy, hemimandibulectomy, and partial resection of the lip on the left side. Rehabilitation of this patient was done using silicone lip prosthesis and maxillary obturator. These prostheses improve the esthetics, function, and provide confidence to the patient, hence improving his social life. The lip prosthesis was retained by two magnets that were attached to the denture cum obturator to provide good retention and stability to the lip prosthesis.