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Proplast implants used in otology and in facial reconstructive surgery.

Proplast, a self-stabilising alloplastic material, was evaluated in ear surgery and in facial reconstructive surgery. Proplast implants were used on 33 patients to reconstruct the ossicular chain (total or partial ossicular replacement prosthesis), or to rebuild the mastoid cavity. The lack of extrusion over a 24-month period is encouraging. In facial reconstructive surgery 11 patients received Proplast implants to augment and restore facial contours. Contamination with saliva remains a problem, owing to the high porosity of Proplast, which could harbour infection. When Proplast was sterile when implanted, no extrusion appeared over a 12-month period. Although the patients presented here were followed up for a relatively short time, they provide reason for some optimism that the vexed question of alloplastics applied in the field of ear, nose and throat surgery may be solved.

Chin↗

Facial implants.

The application of endosseous dental implants for the retention and stabilization of extraoral prostheses and hearing aids has been shown to be effective functionally and aesthetically. Implants have reduced the need for adhesive use, simplifying cleaning procedures and thus extending the life of the prosthesis. Implant-retained prostheses have provided patients the opportunity to participate in routine activities such as work, shopping, swimming, and jogging with less fear of losing their prosthesis. The implants' impact on patients has resulted in their ability to function in society with confidence that their defects will be less noticeable and their ability to respond to the environment enhanced. The culmination of these effects have without doubt improved the overall quality of life for patients. As with any new technology, its application will encounter unanticipated problems and some limitations in use. As the art and science of this technique evolve, however, it is anticipated that it will result in the ability to provide improved health care for patients.

Activities of Daily Living↗

Surgical considerations for endosseous implants in the craniofacial region: a 3-year report.

From 1987 to 1990, 28 patients were treated with titanium implants (Brånemark flange fixtures) in the craniofacial area for the support of craniofacial prosthesis or anchorage of bone-conduction hearing aids in the Orofacial Implant Center at the University of California, Los Angeles (UCLA). A total of 88 implants were placed, of which 22 were placed in previously irradiated areas. Twenty-three of the implants were placed in the orbital area, 37 in the mastoid area, 20 in the nasal area, and eight in various other craniofacial regions. Seven implants were lost in four different patients. The proper location and positioning of implants in specific areas of the craniofacial regions, as well as soft-tissue complications and management, are discussed.

Adolescent↗

Misfit and functional loading of craniofacial implants.

PURPOSE: This study sought to develop an understanding of the magnitude and types of loads generated on craniofacial implants supporting an auricular prosthesis. MATERIALS AND METHODS: Strain gauges were used to measure the in vitro and in vivo misfit loads generated when connecting auricular-style superstructures to implants and the in vivo functional load generated during the removal and insertion of the auricular prostheses. In addition, the vertical misfit of the 11 custom-built two-implant superstructures used in the in vitro study was measured. RESULTS: Superstructures used in the in vitro study that were considered clinically passive still had considerable preloads. In addition, the calibrated loads, which would result from the vertical misfit alone, did not account for the magnitude of the generated preloads. CONCLUSION: The clinical definition of misfit based on vertical distortion of the superstructure did not quantify the resulting misfit load. Measured in vivo functional loads were smaller than the misfit loads.

Adult↗

Clinical evaluation of implants retaining edentulous maxillary obturator prostheses.

PURPOSE: Fabricating a maxillary obturator can be challenging. Placement of implants can have a dramatic effect on the stability and retention of the prosthesis in the edentulous maxillectomy patient. This article provides clinical retrospective analysis of osseointegrated implants used to retain maxillary obturators. MATERIAL AND METHODS: Patient charts and radiographs were reviewed to determine implant status, bone loss patterns, and implant survival rates. Twenty-six patients were included with 102 implants placed, from which there were 19 intact withdrawals (implants lost because of recurrent disease or patient death), five implants with unknown status, 24 implant failures, and 54 functional implants. RESULTS: The overall survival rate for implants in this patient population was 69.2%. The percent implant survival rate was 63.6% for the irradiated group (67.0% before radiation, 50.0% after radiation) and 82.6% for the nonirradiated group. Implants located in anterior sites demonstrated statistically significant differences in annual bone height changes compared with posterior sites. CONCLUSIONS: The majority of implant failures (18 of 24) occurred either at stage II surgery or before loading. Implants placed during tumor resection, implants placed within the maxillectomy defects, and implants receiving postoperative radiation demonstrated low survival rates.

Adult↗

Quality of life of maxillectomy patients using an obturator prosthesis.

BACKGROUND: The psychosocial adaptation of patients who had undergone a resection of the maxilla for cancer of the maxillary antrum and/or hard palate with the placement of an obturator prosthesis to restore speech and eating function was studied. METHODS: Forty-seven patients were interviewed who had a maxillectomy with an obturator prosthesis at Memorial Sloan-Kettering Cancer Center, an average of 5.2 years (SD = 2.4 years) ago, 94% of whom had some of their soft palate resected. Interviews were conducted by telephone by a trained research interviewer, using a series of questionnaires to assess their satisfaction with the functioning of their obturator, and the psychological, vocational, family, social, and sexual adjustment. Measures included the Obturator Functioning Scale (OFS). Psychosocial Adjustment to Illness Scale (PAIS), Mental Health Inventory (MHI), Impact of Event Scale, and Family Functioning Scale. RESULTS: Using multiple regression and discriminant function analyses, satisfactory functioning of the obturator prosthesis, as measured by the OFS, was found to be (1) the most highly significant predictor of adjustment, as measured by the PAIS (p < .0001) and the MHI Global Psychological Distress Subscale (MHI-GPD) (p < .001), and (2) significantly related to their perception of the negative socioeconomic impact of cancer upon their lives. The most significant predictor of better obturator functioning were the extent of resection of their soft palate (one third or less, p < .001), and hard palate (one fourth or less, p < .01). Specific aspects of obturator functioning that most significantly correlated with better adjustment (PAIS, MHI-GPD) were: less difficulty in pronouncing words (r = .40 and r = .51, respectively, p < .01), chewing and swallowing food (r = .27-.46, p < .05), and less change in their voice quality after surgery (r = .52 and r = .56, respectively, p < .001). CONCLUSIONS: These findings suggest that a well-functioning obturator significantly contributes to improving the quality of life of maxillectomy patients.

Adaptation, Psychological↗

Irritation test of tissue adhesives for facial prostheses.

STATEMENT OF PROBLEM: Adhesives are commonly used to improve the retention of a facial prosthesis to the skin. Although no requirement exists for facial prosthetic adhesives, an adhesive should be nonirritating and nontoxic. PURPOSE: This study assessed the irritative potential of facial prosthetic adhesives by using an in vitro technique for detection of eye-irritating chemicals. MATERIAL AND METHODS: Ten adhesives were evaluated by the hens egg test chorioallantoic membrane method. Adhesives were applied to the chorioallantoic membrane in fertilized hen eggs, and the membrane examined by a photomacroscope for injury to the blood vessels. The average irritation score was calculated from the recorded times for the debut of hemorrhage, lysis, and coagulation, and the products were classified as being non, slight, moderate, or strong irritants, based on the irritation score. RESULTS: The predominant injury to the membrane was coagulation of blood vessels, and the exposure time needed to initiate the reaction was dependent on the composition of the product. Four products were classified as strong irritants, 1 as moderate, and the remaining 5 as slight or nonirritant. CONCLUSION: On the basis of a test for eye irritation, the irritant potential of tissue adhesives varied from non to severe. The most severe reactions were mainly seen in products containing the solvent ethyl acetate.

Acetates↗

[Effects of unilateral cleft lip and palate prosthesis on the development of maxillary and facial soft tissue].

OBJECTIVE: The effect of unilateral cleft lip and palate prosthesis on the development of maxillary and facial soft tissue was investigated. METHODS: The standard cephalometric measurement was used in patients with complete unilateral cleft lip and palate operated in different periods. We obtained data by measurement. RESULTS: Hard tissue: ANS-X, PNS-X and N-ANS in the group of patients were statistically different from those of the normal control group, but in ANS-PNS and N-PO, there is no statistical difference in these two groups. Angles of hard tissue: There is statistical difference in < N. W. ANS and < SNA between the control and the group of patients. There is only statistical difference in < SNB between the D group and the control group. There is no difference among other groups. Ratios of hard tissue: The ratios of ANS-X/S-X and PNS-X/S-x in the control group were higher than those of the group of patients, and the ratios of S-Go/N-Po, Ar-Go/N-Po and N-Po/AN in the group of patients were higher than those of the control group. The ratio of NMC/SUBN: It is the highest ratio in the control group, and there is no difference between ratios in the control group and the C group, but there is statistical difference between the control and other patient groups (P < 0.05). CONCLUSION: Comparing with normal persons, the defect of maxillary length development is apparent in the patients with complete unilateral cleft lip and palate due to congenital development deformity. The figure of soft tissue in patients with unilateral cleft lip and palate is anastomotic with the figure of their hard tissue. The excavation of bony middle 1/3 in face results in paramorphia of soft tissue adhering on the bony tissue. We can conclude that in order to obtain better articulation function, the palatoplasty should be carried out early.

Adolescent↗

Self-induced nasal ulceration.

BACKGROUND: Nasal ulcerations have many causes. Ulcerations that are self-induced are difficult to diagnose and treat. Two rare conditions with self-induced nasal ulceration are trigeminal trophic syndrome (TTS) and factitious disorder (FD). Trigeminal trophic syndrome is characterized by trigeminal anesthesia, nasal alar ulceration, and facial paresthesia. Appearance of the nasal ulcer after trigeminal ablation for neuralgia is diagnostic. Self-induced nasal lesions that occur in FD are primarily distinguished from those in TTS by the presence of normal trigeminal nerve function and frequent patient denial of lesion manipulation. OBJECTIVES: To increase physician awareness of the disorders leading to self-induced nasal ulceration and to discuss management issues in our patient series. DESIGN: A retrospective review of 7 cases in which the patients presented for reconstructive consultation between March 1985 and October 1997 and were found to have self-induced nasal ulcerations. SETTING: Tertiary university medical center. RESULTS: Five patients were identified with TTS and underwent nasal reconstruction an average of 43 months (range, 4-72 months) after nasal ulcer presentation. Four of the 5 patients developed ulcer recurrence between 1 and 58 months after reconstruction; secondary reconstruction resulted in recurrence in 2 of these patients. Two patients were identified with FD and self-induced nasal ulceration. One of these 2 patients underwent total nasal reconstruction 15 months after ulcer occurrence and developed recurrence 2 weeks after surgery. CONCLUSIONS: Self-induced nasal ulceration remains a difficult condition to diagnose and treat. Readily treatable conditions should be excluded, and diagnostic workup should include tissue biopsy and laboratory studies. Patients with TTS may have associated ocular findings, and those who do should be referred for ophthalmologic consultation. Surgical reconstruction can be considered in the highly motivated patient with TTS; however, delayed ulcer recurrence is common. Patients with FD should be treated primarily with local wound care and referred for psychiatric intervention. We strongly recommend nasal prosthetic devices as the primary means of aesthetic correction and discourage surgical repair in the patient with FD.

Adolescent↗

Malar augmentation: a 5-year retrospective review of the silastic midfacial malar implant.

OBJECTIVES: To determine the effectiveness and safety of the Silastic midfacial malar implant and to review indications, patient selection, technique, and complications of malar augmentation. DESIGN: Five-year retrospective review of clinical cases with at least 2-year follow-up. PATIENTS: A cohort of 60 consecutive private patients with complaints of malar hypoplasia or facial asymmetry. SETTING: A plastic surgery clinic. INTERVENTION: Silastic midfacial malar implants were fitted in each patient. Most underwent implantation via the canine fossa approach and in conjunction with another facial plastic procedure. MAIN OUTCOME MEASURES: Subjective patient satisfaction, photographic grading using a visual analog scale, and complications. RESULTS: Of the 60 patients, 51 (85.0%) reported an excellent result after at least a 2-year follow-up. Ten patients (16.7%) had some form of undesirable sequelae; however, only 4 (3.4%) of 118 implants had to be revised. Photographically, all 60 patients graded postoperative improvement. CONCLUSIONS: Findings support the contention that the Silastic midfacial malar implant is a safe and effective alloplastic alternative to treat malar hypoplasia and facial asymmetry. The complication and revision rates are acceptable. Relative technical ease of insertion makes malar augmentation an excellent adjunct for rhytidectomy and rhinoplasty.

Adolescent↗

Comparison of functional and quality-of-life outcomes in patients with and without palatomaxillary reconstruction: a preliminary report.

BACKGROUND: Orodental rehabilitation of hemipalatomaxillectomy defects can be accomplished by using a prosthetic obturator or a vascularized bone-containing free flap. Whereas prosthetic obturation offers several advantages, including the opportunity for immediate dental restoration without the need for further surgery, vascularized bone grafts provide permanent closure of the oronasal communication and bone sufficient for the placement of osseointegrated implants. OBJECTIVE: To compare the functional and quality-of-life (QOL) outcomes in patients rehabilitated with a prosthetic obturator with defect-matched patients who underwent reconstruction with a vascularized bone-containing free flap. METHODS: Four hemipalatomaxillectomy patients rehabilitated with a tissue-borne prosthetic obturator were compared with 4 defect-matched hemipalatomaxillectomy patients who underwent reconstruction with a vascularized bone-containing free flap. All of the patients were objectively assessed for speech, mastication, and QOL. Functional status was assessed by mastication testing, voice analysis, and nasorhinometry. Swallowing-related QOL was assessed using a patient-reported, validated swallowing QOL questionnaire, and donor site morbidity was assessed using upper extremity and lower extremity questionnaires. RESULTS: Patients who underwent reconstruction with a vascularized bone-containing free flap achieved higher mastication and speech assessment scores with less oronasal reflux than defect-matched patients rehabilitated with a prosthetic obturator. Swallowing QOL and donor site assessments demonstrated that compared with their prosthetic counterparts, reconstruction patients enjoyed a better QOL without incurring significant donor site morbidity. CONCLUSIONS: Although palatomaxillary reconstruction with vascularized bone-containing free flaps requires a second operative site, this method of orodental rehabilitation of the hemipalatomaxillectomy defect can achieve superior functional and QOL outcomes relative to defect-matched patients rehabilitated with a prosthetic obturator.

Humans↗

The biologic basis for the clinical application of the silicones. A correlate to their biocompatibility.

The polysiloxanes (silicones) are a group of inert and inorganic compounds that were introduced over two decades ago. The pure form, termed medical-grade silicone, has a wide variety of clinical applications. Almost all surgical fields have used a product made of silicone. Silicone has been found to be an inert material, with minimal reaction of the biologic system to its presence. However, multiple clinical problems still exist due to certain applications of silicone products. The problems are related to its surface properties; In the blood thrombi form around silicone implants that may dislodge and cause symptoms around the implants. Scar formation may occur, and internal wound healing problems in the breast cause spherical contracture. In the eyes, where transparencies are needed, as in the intraocular lens implant, the scar interfaces with the visual image transmissions. Some of these internal problems relate to the hydrophobic nature of the silicone surface and have been resolved in part by adsorbing a wetting agent, such as povidone, to the surface. Such obviation has gained wide clinical application in surface coating of the intraocular lens. In search of an ideal implantable material, silicone, the most applicable, is still far from being called the ideal implant. Perhaps with the changes of its surface properties, such as introducing wetting agents to its surface, a new dimension in clinical applications will open the horizons of silicone in the 1980s.

Animals↗

Functional dental rehabilitation of massive palatomaxillary defects: cases requiring free tissue transfer and osseointegrated implants.

BACKGROUND: Mandibular reconstruction with functional dental rehabilitation using a free tissue transfer bone flap as the substrate for osseointegrated implant-borne or implant-retained dental prostheses is well described. Similar use of these techniques in maxillary dental rehabilitation is less frequent and has received less attention in the literature. However, in selected cases of extensive composite defects of the maxilla, free tissue transfer reconstruction of the maxillary arch and the use of implant-borne or implant-retained dental prostheses is the only satisfactory method of achieving functional dental rehabilitation. METHODS: Three cases of maxillary reconstruction and dental rehabilitation using free tissue transfer with implant-borne or implant-retained prostheses are presented. Patient selection, reconstructive technique, and the biomechanical considerations in maxillary dental rehabilitation of large palatomaxillary defects are presented. RESULTS: The patients in this report were restored to full maxillary dental functioning. One implant of 17 implants placed in free flap bone was lost due to failure of osseointegration; 94% of the implants placed are stable an average of 18 months after dental rehabilitation was complete. CONCLUSIONS: In selected patients with extensive palatomaxillary defects due to ablative surgery or trauma, the use of free tissue transfer and osseointegrated implant-borne or implant-retained dentures may be the only method possible to restore maxillary dental function. Dental rehabilitation of large maxillary defects presents a number of biomechanical challenges which must be clearly understood and overcome to achieve a long-term, functional dental rehabilitation.

Adult↗

Long-term ingrowth and apposition of porous hydroxylapatite implants.

Bone implant materials are often used to fill in bone gaps that frequently result from orthognathic and craniofacial reconstruction. The substrate hydroxylapatite (HA) is commonly implanted into the bone voids, resulting from these conditions due to its established biocompatibility and osteoconductive properties. The porous structure of HA provides a three-dimensional guideline for fibrovascular ingrowth, facilitating the process that ultimately results in the deposition of new bone. Porous HA (Interpore, 200) implants were implanted in the mandible or maxilla of nine humans and removed after 14-30 months (19.1-month mean). There was no evidence of an inflammatory response. The sample composition and apposition against the implant were determined using point counting and a digitizing tablet and software. Percent ingrowth in available space (%IAS) was defined as %Bone/(%Bone + %Void). A new measure of implant saturation (%IAS-%Apposition of bone) was established to help determine the fundamental manner in which long-term HA implants incorporate bone. In the mean, the samples were composed of 27% bone, 21% void, and 53% implant. The apposition percentages averaged 60% bone, 16% void, and 24% soft tissue. The %IAS averaged 58%, and implant saturation averaged -3%, indicating that a near-balance between the implant and surrounding bone has been established.

Adolescent↗

Effect of nitinol implant porosity on cranial bone ingrowth and apposition after 6 weeks.

The present study addresses two aspects of the use of nitinol in cranial bone defect repair. The first is to verify that there is substantial bone ingrowth into the implant after 6 weeks; the second is to determine the effect of pore size on the ability of bone to grow into the implant during the early (6-week) postoperative period. Porous equiatomic (equal atomic masses of titanium and nickel) nickel-titanium (nitinol) implants with three different morphologies (differing in pore size and percent porosity) were implanted for 6 weeks in the parietal bones of New Zealand White rabbits. Ingrowth of bone into the implants and apposition of bone along the exterior and interior implant surfaces were calculated. The mean pore size (MPS) of implant type #1 (353 +/- 74 microm) differed considerably from implant types #2 (218 +/- 28 microm) and #3 (178 +/- 31 microm). There was no significant difference among implant types in the percentages of bone and void/soft tissue composition of the aggregate implants. The amount of bone ingrowth also was not significantly different among the implant types. Implant #1 was significantly higher in pore volume and thus had a significantly higher volume of ingrown bone (2.59 +/- 0.60 mm3) than implant #3 (1. 52 +/- 0.66 mm3) and a greater amount, but not significantly greater, than implant #2 (1.76 +/- 0.47 mm3). Pore size does not appear to affect bone ingrowth during the cartilaginous period of bone growth in the implant. This implies that within the commonly accepted range of implant porosities (150-400 microm), at 6 weeks bone ingrowth near the interface of nitinol implants is similar.

Alloys↗

Quantification of bone ingrowth into porous block hydroxyapatite in humans.

This study sought to quantify bone ingrowth from a single bone-implant surface into porous block hydroxyapatite used in maxillofacial applications. Seventeen maxillary hydroxyapatite implants (implant time of 4-138 months, 39-month mean) were harvested for analysis from 14 patients. The implants had been placed into the lateral maxillary wall during orthognathic surgery, juxtapositioned to the maxillary sinus. Ingrowth was measured in 100-microm increments from a bone-implant interface to a depth of 1500 microm. Bone ingrowth averaged over the 14 patients (0-1100 microm depth) is described by the equation % ingrowth - 20% * (depth in millimeters) + 41.25% (R2 = 0.98, n = 10 incremental depths). Beyond 1100 microm, the average ingrowth remained constant at 15.0 +/- 0.7%. The duration of implantation also showed as affect on the percent ingrowth into the implants at the incremental depths, and the percent ingrowth asymptotically approached a maximum. Overall, the composite average data from all depths is best described by the logarithmic function % ingrowth = 15% * ln(implantation time in months) - 24.0% (R2 = 0.71, n = 14 patients). Several factors may come into play in determining bone ingrowth including the mechanical environment, the osteoconductivity of the implant material, and the osteogenic capability of the tissues in the pore spaces. Measurements of bone ingrowth are most influenced by the depth into the implant and the time the implant was in the body; the age of the patient had little affect on bone ingrowth.

Adolescent↗