Early implant placement with or without alveolar ridge preservation in single tooth gaps renders similar esthetic, clinical and patient-reported outcome measures: One-year results of a randomized clinical trial.

OBJECTIVES: To test whether early implant placement with alveolar ridge preservation (ARP) results in different esthetic, clinical and patient-reported outcome measures (PROMs) compared with early implant placement without ARP. MATERIAL AND METHODS: Seventy-five patients requiring single tooth extraction in the anterior maxilla were recruited. Following tooth extraction, the patients were randomly allocated to three groups: (a) ARP using demineralized bovine bone mineral containing 10% collagen (DBBM-C) covered by a collagen matrix (CM) (n = 25), (b) ARP using DBBM-C covered with a palatal graft (PG) (n = 25) and (c) spontaneous healing (control) (n = 25). Eight weeks after tooth extraction, a CBCT was taken and early implant placement was performed in all patients. Esthetic, clinical and PROMs were evaluated one year post-loading. RESULTS: A total of 70 patients were available for re-examination at one year post-loading. The median mid-facial mucosal margin change amounted to -0.02 mm (IQR -0.27-0.46) in the CM group, -0.13 mm (IQR -0.44-0.25) in the PG group and -0.14 mm (IQR -0.29-0.07) in the control group, with no significant differences between the groups. Mean PES scores amounted to 7.0 ± 1.4 in the CM group, 7.1 ± 1.5 in the PG group and 7.3 ± 1.7 in the control group without significant differences between the groups. Plaque, bleeding on probing and probing depth did not differ between treatment groups. PROMs in general revealed no significant differences between the groups. CONCLUSION: Early implant placement with ARP using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP. When a failing tooth can be replaced with an implant within 2 months after tooth extraction, the added value of ARP might be clinically negligible.

Soft tissue contour and radiographic evaluation of ridge preservation in early implant placement: A randomized controlled clinical trial.

OBJECTIVES: To compare two ridge preservation techniques and spontaneous healing in terms of hard and soft tissue changes 2 months after tooth extraction. MATERIAL AND METHODS: The study was designed as a randomized controlled trial and included 75 patients. After single tooth extraction in the maxillary incisor/premolar area, patients were randomly allocated to one of the following groups: (a) ridge preservation with a xenogeneic bone substitute covered with a collagen matrix (CM-group), (b) ridge preservation with a xenogeneic bone substitute covered with a free palatal graft (PG-group) or (c) spontaneous healing (control). Eight weeks after tooth extraction, implants were placed and clinical, profilometric and radiographic evaluations were performed. In addition, the need for further guided bone regeneration (GBR) at implant placement was assessed. The differences between the treatment groups were compared with the One-way ANOVA or Kruskal-Wallis test with the corresponding post hoc analysis. The proportions of the categorical parameters were compared with the Fisher´s exact test. RESULTS: Seventy-five patients underwent early implant placement 8 weeks after tooth extraction and were evaluated. CM-group (-0.9 SD 0.6 mm) and PG-group (-1.0 SD 0.8 mm) showed less horizontal bone resorption compared to the control group (-3.2 SD 2.1 mm) (p < .001). Moreover, the necessity of GBR at implant placement was significantly less in CM-group (32%) and PG-group (24%) when compared to control group (72%) (p = .001). Patients in CM-group experienced less pain than PG-group, one week after tooth extraction (p = .042). No significant differences were found regarding graft evaluation, post-operative complications, and soft tissue contour. CONCLUSIONS: Ridge preservation using a xenogeneic bone substitute covered with a collagen matrix or a palatal graft, results in less bone resorption and fewer GBR procedures at early implant placement compared to spontaneous healing.

The effect of resorbable membranes on one-stage ridge augmentation in anterior single-tooth replacement: A randomized, controlled clinical trial.

AIM: To evaluate the effect of resorbable membranes on one-stage ridge augmentation procedures in small (2-4 mm) buccal bony dehiscences in anterior maxillary single-tooth replacement. MATERIALS AND METHODS: Patients with a buccal bony dehiscence after implant placement in the esthetic zone were randomly allocated to one-stage ridge augmentation with (M+) or without a membrane (M-). Second-phase surgery was performed after 8 weeks, and follow-up was performed 1, 6, and ≥12 months after loading. Outcomes included implant survival and success, complications, clinical and radiographic parameters, esthetic results and patient satisfaction. RESULTS: Fifty-two patients were randomized to one-stage ridge augmentation with (n = 25) or without use of a membrane (n = 27). No significant differences in implant survival and success have been observed. The risk of having a small mucosal dehiscence was more than six times higher in the M+ group than in the M- group (RR 6.24, 95% CI 0.81 to 48.21). At the last follow-up, the bleeding index (BI) was marginally higher in the M+ group (14/9/2/0) compared to the M- group (24/2/0/0) (U = 205, Z = -2.97, p = .003, r = .42). The median change in marginal bone level was statistically lower in the M+ group (0.06 mm) than the M- group (0.60 mm) at last follow-up (U = 120, Z = -2.73 a p = .006 r = .42). Total pink esthetic index (PES) and white esthetic score (WES) and combined PES/WES were not significantly different between treatment groups at more than 12 months after loading. Only the subcategory root convexity/soft tissue color scored significantly lower in the M+ group (1.5) compared to the M- group (2.0) at the last follow-up (U = 172, Z = -2.34, p = .019 r = .34). No differences were found in patient satisfaction. CONCLUSION: The use of a resorbable membrane in small buccal bony dehiscences in anterior maxillary single-tooth replacement resulted in less marginal bone loss, but showed more mucosal dehiscences, higher bleeding scores and lower scores on root convexity and soft tissue color after at least one year of loading. No effect was seen on implant survival and success, overall esthetic results, and patient satisfaction. The research protocol was registered at the Dutch Trial Register (NTR) with ID NTR6137.

Alveolar ridge changes 1-year after early implant placement, with or without alveolar ridge preservation at single-implant sites in the aesthetic region: A secondary analysis of radiographic and profilometric outcomes from a randomized controlled trial.

OBJECTIVES: To assess both the radiographic and profilometric outcomes of early implant placement with or without alveolar ridge preservation (ARP) (using two different ARP techniques) after 1 year of loading. MATERIALS AND METHODS: Seventy-five patients with a failing single tooth in the anterior maxilla were randomly allocated to three groups (1:1:1): (a) ARP using demineralized bovine bone mineral containing 10% collagen (DBBM-C) covered by a collagen matrix (CM), (b) ARP using DBBM-C covered with a palatal graft (PG), and (c) unassisted socket healing (control). Eight weeks after tooth extraction, early implant placement was performed in all patients. Cone-beam computed tomography (CBCT) and impressions were taken 8 weeks after tooth extraction (ARP/unassisted healing) prior to implant placement and 1-year post-loading. Radiographic and profilometric outcomes were evaluated. RESULTS: Out of the 70 patients available for re-examination at 1-year post-loading, 55 datasets could be assessed (ARP-CM 19; ARP-PG 17; Control 19). The need for additional guided bone regeneration (GBR) at implant placement amounted to 31.6% (ARP-CM), 29.4% (ARP-PG), and 68.4% (unassisted healing). Adjusted models revealed that residual buccal bone height and additional GBR at implant placement significantly influenced the magnitude of the alveolar changes at 1 year (p < 0.05). In patients with ARP (group ARP-CM or ARP-PG) without additional GBR, the presence of bone convexity amounted to 36.0% (9/25) at 1-year post-loading. For patients that received ARP and additional GBR at implant placement, the frequency of bone convexity increased to 72.7% (8/11) (p = 0.042). Regarding profilometric measurements, a tendency toward agreement with radiographic outcomes was observed. CONCLUSIONS: Early implant placement with ARP can attenuate alveolar ridge changes at 1-year post loading by minimizing both radiographic and profilometric alterations. However, early implant placement with simultaneous GBR consistently yields superior radiographic and profilometric outcomes, regardless of whether ARP is performed.

ITI consensus report on zygomatic implants: indications, evaluation of surgical techniques and long-term treatment outcomes.

OBJECTIVES: The aim of the ITI Consensus Workshop on zygomatic implants was to provide Consensus Statements and Clinical Recommendations for the use of zygomatic implants. MATERIALS AND METHODS: Three systematic reviews and one narrative review were written to address focused questions on (1) the indications for the use of zygomatic implants; (2) the survival rates and complications associated with surgery in zygomatic implant placement; (3) long-term survival rates of zygomatic implants and (4) the biomechanical principles involved when zygoma implants are placed under functional loads. Based on the reviews, three working groups then developed Consensus Statements and Clinical Recommendations. These were discussed in a plenary and finalized in Delphi rounds. RESULTS: A total of 21 Consensus Statements were developed from the systematic reviews. Additionally, the group developed 17 Clinical Recommendations based on the Consensus Statements and the combined expertise of the participants. CONCLUSIONS: Zygomatic implants are mainly indicated in cases with maxillary bone atrophy or deficiency. Long-term mean zygomatic implant survival was 96.2% [95% CI 93.8; 97.7] over a mean follow-up of 75.4 months (6.3 years) with a follow-up range of 36-141.6 months (3-11.8 years). Immediate loading showed a statistically significant increase in survival over delayed loading. Sinusitis presented with a total prevalence of 14.2% [95% CI 8.8; 22.0] over a mean 65.4 months follow-up, representing the most common complication which may lead to zygomatic implant loss. The international experts suggested clinical recommendations regarding planning, surgery, restoration, outcomes, and the patient's perspective.

Esthetics and Patient-Reported Outcomes of Implants Placed with Guided Bone Regeneration and Complete Native Bone: A Prospective Controlled Clinical Trial.

PURPOSE: When encountering a buccal bone defect during implant placement, guided bone regeneration (GBR) is a well-accepted method for bone reconstruction. However, it is still unclear if the esthetic and patient-reported outcomes are comparable to implants placed in native bone. The purpose of this prospective trial was to compare implants placed with a GBR procedure for a small (≤ 4 mm) buccal defect with implants placed completely in native bone (control). MATERIALS AND METHODS: Patients were allocated to the GBR group or control group during implant placement in the esthetic zone. Implants were placed after at least 12 weeks of healing of the extraction sockets. A buccal bone defect of ≤ 4 mm resulted in allocation to the GBR group. Follow-up was performed until 12 months after loading. Outcome measurements were as follows: esthetic scores, patient-reported outcome measurements, implant survival and complications, clinical indices, and radiographic measurements. RESULTS: In total, 45 patients were included, of which 23 underwent a GBR procedure after implant placement, and in 22 patients no GBR was necessary. No significant differences in esthetic outcomes were seen between the two groups. At the final follow-up, a mean pink esthetic score (PES) of 7.8 (SD: 1.5) was seen for the GBR group and 8.4 (SD: 1.4) for the control group. Regarding the white esthetic score (WES), a mean of 9.1 (SD: 1.0) was found for both groups. Patients of both groups were equally satisfied with their mucosa and crown. A mean visual analog score (VAS) for the soft tissues of 8.6 (SD: 1.0) in the GBR group and 8.8 (SD: 0.9) for the control group was noted. A mean VAS of 9.2 (SD: 0.8) was noted for the crown in the GBR group and 8.6 (SD: 2.0) in the control group. Implant survival was 100%, and there were no significant differences in complications, plaque/bleeding/gingiva indices, width of attached mucosa, and marginal bone loss. CONCLUSION: Implants placed in the esthetic zone with GBR or complete native bone coverage showed successful esthetic outcomes and satisfied patients with predictable clinical and radiographic parameters after more than 1 year of loading. Within the limits of this study, GBR for a small buccal bone defect seems to be a reliable technique with good esthetics and patient-reported outcomes.

The future of biologic agents in the treatment of Sjögren's syndrome.

The gain in knowledge regarding the cellular mechanisms of T and B lymphocyte activity in the pathogenesis of Sjögren's syndrome (SS) and the current availability of various biological agents (anti-TNF-alpha, IFN- alpha, anti-CD20, and anti-CD22) have resulted in new strategies for therapeutic intervention. In SS, various phase I and II studies have been performed to evaluate these new strategies. Currently, B cell-directed therapies seem to be more promising than T cell-related therapies. However, large, randomized, placebo-controlled clinical trials are needed to confirm the promising results of these early studies. When performing these trials, special attention has to be paid to prevent the occasional occurrence of the severe side effects.

The clinical value of membranes in bone augmentation procedures in oral implantology: A systematic review of randomised controlled trials.

PURPOSE: To determine the clinical value of membranes in bone augmentation procedures such as ridge augmentation with simultaneous (one-stage) and delayed (two-stage) implant placement, sinus augmentation surgery, ridge preservation and immediate implant placement. MATERIALS AND METHODS: In April 2016, Embase, Medline (Ovid-SP), Cochrane Central, Web of Science and PubMed (as supplied by the publisher) were searched. There were no restrictions regarding language or publication date. Randomised controlled trials that reported membranes in bone augmentation procedures with a minimum follow-up period of 6 months after implant loading or that described geometrical changes of the bone graft at re-entry were included. Membrane placement had to be the only variable in the procedure. Outcomes were implant failure, complications, horizontal bone gain and resorption, graft resorption, defect height reduction, marginal bone loss around implants, aesthetic results and patient satisfaction. The results were pooled using fixed-effect models with mean differences (MDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes. RESULTS: After screening the titles and abstracts of 1843 papers, 32 potentially eligible articles were selected. Seventeen articles involving 10 trials were included in this review. These studies presented outcome data for 355 patients. Seven trials were considered to be at a high risk of bias, two at a low risk of bias and one at an unclear risk of bias. Insufficient evidence was found to determine whether there were differences in implant failure rates, marginal bone level changes, aesthetic results or patient satisfaction. For one-stage ridge augmentation (two trials; n = 52), there was evidence of more horizontal bone gain (MD: 0.84 mm, 95% CI: 0.46 to 1.21, P < 0.00001; two trials), defect height reduction (MD: 18.36%, 95% CI: 10.23 to 26.50, P < 0.00001; two trials), and prevention of graft resorption (P = 0.004; one trial) in favour of the membrane-covered group, although substantial heterogeneity was found for horizontal bone gain (Chi2; P = 0.05, I2=74%). There was insufficient evidence to determine whether any differences exist in two-stage ridge augmentation (three trials; n = 81), sinus augmentation (one trial; n = 104) and ridge preservation (one trial; n = 20). For immediate implant placement (three trials; n = 98), there was evidence of an increased defect height reduction in favour of the membrane-covered groups (MD: 6.25%, 95% CI: 1.67 to 10.82, P = 0.007; two trials), although with substantial heterogeneity (Chi2; P = 0.03, I2 = 79%). More complications were observed when a membrane was used (OR: 2.52, 95% CI: 1.07 to 5.93, P = 0.03; three trials). CONCLUSIONS: There is insufficient evidence regarding the effects of membranes on bone augmentation procedures to support any definitive conclusions. Only 10 studies were included; they had limited sample sizes and short follow-up periods, and the majority were at a high risk of bias. However, no difference in implant failure was found, and the possible clinical value is still unknown, as long-term clinical parameters such as marginal bone loss, aesthetic results and patient satisfaction have been insufficiently studied. Conflict-of-interest and source-of-funding statement: The authors declare that they have no possible conflicts of interest. No funding for this review was received.

Systemic diseases and the risk of developing salivary stones: a case control study.

OBJECTIVE: To investigate the possible relationship between the presence of salivary stones and systemic diseases, medication, smoking, and alcohol consumption. STUDY DESIGN: A retrospective, case control study. Medical records of patients with salivary stones and those of control patients without salivary stones were retrospectively reviewed. Data regarding the affected salivary gland, the presence of systemic disease, and the use of medication, tobacco, and alcohol were recorded. Statistical analysis was performed using the Fisher Exact tests. RESULTS: Medical records of 208 patients with salivary stones and those of 208 control patients were reviewed. Of the patients diagnosed with salivary stones, the submandibular gland was affected in 85.6% of the patients, the parotid gland in 9.6%, and the sublingual gland in 2.4% of the patients. None of the recorded systemic diseases was more prevalent in patients with salivary stones. Patients with salivary stones used significantly more antibiotics compared with the control group (P = .037). No significant differences were observed for other types of medication. There was no correlation between salivary stone formation, smoking, and alcohol consumption. CONCLUSIONS: The present study suggested that systemic diseases, medication, smoking, and alcohol consumption play no or only a limited role in the onset of salivary stones.

[Sialendoscopy for obstructive disorders of the salivary glands]. / Sialendoscopie voor obstructieve speekselklieraandoeningen.

Obstructive disorders of the salivary glands usually manifest as a swelling which is associated with meals ('mealtime syndrome') as well as inflammation of the gland. Obstruction of the salivary ducts of the parotid and submandibular glands is usually caused by a salivary stone, mucous plug or by a stenosis. Until recently, the options for diagnosis and treating these conditions were limited. Ultimately, the decision to remove the salivary gland was often made. Sialendoscopy is a recently developed semi-rigid optical technique that can be used to detect and usually treat obstructions in the salivary ductal system. This new, minimally invasive technique has resulted in the reduction of morbidity related to salivary gland obstruction. In many patients, surgical removal of the salivary gland can be avoided by using this technique.

Treatment of mucosa-associated lymphoid tissue lymphoma in Sjogren's syndrome: a retrospective clinical study.

OBJECTIVE: To retrospectively analyze the clinical course of patients with mucosa-associated lymphoid tissue (MALT)-type lymphoma of the parotid gland and associated Sjögren's syndrome (SS). METHODS: All consecutive patients with SS and MALT lymphoma (MALT-SS) diagnosed in the University Medical Center Groningen between January 1997 and January 2009 were analyzed. Clinical course and treatment outcome of SS and MALT lymphoma were evaluated. RESULTS: From a total of 329 patients with SS, 35 MALT-SS patients were identified, with a median followup of 76 months (range 16-153 mo). MALT lymphoma was localized in the parotid gland in all cases. Treatment consisted of "watchful waiting" (n = 10), surgery (n = 3), radiotherapy (n = 1), surgery combined with radiotherapy (n = 2), rituximab only (n = 13), or rituximab combined with chemotherapy (n = 6). Complete response was observed in 14 patients, partial response in 1 patient, and stable disease in 20 patients. In 6 of 7 patients with initially high SS disease activity (M-protein, cryoglobulins, IgM rheumatoid factor > 100 KIU/l, severe extraglandular manifestations), MALT lymphoma progressed and/or SS disease activity increased after a median followup of 39 months (range 4-98 mo), necessitating retreatment. Only 1 patient with MALT who had low SS disease activity showed progression of lymphoma when left untreated. CONCLUSION: An initially high SS disease activity likely constitutes an adverse prognostic factor for progression of lymphoma and/or SS. Such patients may require treatment for both MALT lymphoma and SS. In SS patients with localized asymptomatic MALT lymphoma and low SS disease activity, a "watchful waiting" strategy seems justified.

Salivary gland parameters and clinical data related to the underlying disorder in patients with persisting xerostomia.

This study assessed salivary gland parameters and clinical data in patients referred to our clinic because of persisting xerostomia of unknown origin, in order to facilitate early diagnosis and recognition of the underlying disorder. Most patients were referred for diagnostic analysis of a possible Sjögren's syndrome (SS). A complete diagnostic work-up was available in all patients (n = 176), including data on salivary gland function, saliva composition, sialography, salivary gland swelling, pattern of complaints, general health, and medication. Patients were diagnosed with SS (n = 62), sialosis (n = 45), sodium retention syndrome (n = 30), or medication-induced xerostomia (n = 9). In 30 patients no disease related to salivary gland pathology was found. Unstimulated whole salivary flow was decreased in all patients, except in patients with sodium retention syndrome and in patients without salivary gland pathology. Submandibular/sublingual salivary flow was lowest in SS patients. SS and sialosis patients had increased salivary potassium concentrations, whereas only SS patients had increased sodium concentrations. About half of the sialosis patients mainly complained of persistent parotid gland swelling. Xerostomia-inducing medication was used by most patients. It was concluded that gland-specific sialometry and sialochemistry is useful in discriminating between the various disorders causing persisting xerostomia.

Salivary proteomic and genomic biomarkers for primary Sjögren's syndrome.

OBJECTIVE: To identify a panel of protein and messenger RNA (mRNA) biomarkers in human whole saliva (WS) that may be used in the detection of primary Sjögren's syndrome (SS). METHODS: Mass spectrometry and expression microarray profiling were used to identify candidate protein and mRNA biomarkers of primary SS in WS samples. Validation of the discovered mRNA and protein biomarkers was also demonstrated using real-time quantitative polymerase chain reaction and immunoblotting techniques. RESULTS: Sixteen WS proteins were found to be down-regulated and 25 WS proteins were found to be up-regulated in primary SS patients compared with matched healthy control subjects. These proteins reflected the damage of glandular cells and inflammation of the oral cavity system in patients with primary SS. In addition, 16 WS peptides (10 up-regulated and 6 down-regulated in primary SS) were found at significantly different levels (P < 0.05) in primary SS patients and controls. Using stringent criteria (3-fold change; P < 0.0005), 27 mRNA in saliva samples were found to be significantly up-regulated in the primary SS patients. Strikingly, 19 of 27 genes that were found to be overexpressed were interferon-inducible or were related to lymphocyte filtration and antigen presentation known to be involved in the pathogenesis of primary SS. CONCLUSION: Our preliminary study has indicated that WS from patients with primary SS contains molecular signatures that reflect damaged glandular cells and an activated immune response in this autoimmune disease. These candidate proteomic and genomic biomarkers may improve the clinical detection of primary SS once they have been further validated. We also found that WS contains more informative proteins, peptides, and mRNA, as compared with gland-specific saliva, that can be used in generating candidate biomarkers for the detection of primary SS.

Variability of flow rate when collecting stimulated human parotid saliva.

The aim of this study was to estimate the accuracy and reproducibility of citric-acid-stimulated parotid saliva sampling. In healthy volunteers a strong correlation (r2 = 0.79) between flow rates from the left and right parotid gland was observed. In patients with Sjögren's syndrome this correlation (r2 = 0.90) was even stronger. The intraindividual variation in healthy volunteers was 23.3 +/- 5.9%. Increasing the number of collections did not reduce this variation significantly. In head and neck cancer patients, to estimate whether repeated measurements result in more reliable baseline values for use in clinical studies, repeated collections did not result in a significant reduction of intrapatient variation, similar to the results with the healthy volunteers. Thus, notwithstanding the good agreement between left and right flow rates, a high variation in parotid flow rates has to be considered when planning clinical trials evaluating the effects of treatment on salivary gland functioning.

The relation between histological, tumor-biological and clinical parameters in deep and superficial leiomyosarcoma and leiomyoma.

PURPOSE: Leiomyosarcomas (LMS) of deep and superficial tissues were examined to identify prognostic markers explaining their different biological behaviour and to define differences between cutaneous and subcutaneous LMS. LMS and leiomyomas (LM) of the skin were compared to and consistent differences that could aid in the (sometimes difficult) diagnosis. PATIENTS: Material was obtained from 27 patients with a deep LMS, 14 with a superficial LMS, and 21 with a LM. METHODS: Proliferation markers (mitotic and Ki-67 indices), DNA ploidy, size, grade, and the amount of apoptosis were studied. Statistical analysis was performed and survival curves were constructed by the Kaplan-Meier method and compared by the log-rank test. RESULTS: Superficial LMS were smaller than deep LMS (p < 0.05), and the overall survival of patients with a superficial LMS was better than with a deep LMS (p < 0.05).Within the group of superficial LMS only entirely subcutaneous, and not cutaneous tumors metastasized.No differences were found in the other examined parameters. Proliferation and apoptotic indices were significantly higher in superficial LMS compared to superficial LM. DISCUSSION: The difference in clinical outcome between patients with a superficial and deep LMS, seems to be related to site and size.The metastatic potential of subcutaneous LMS, however, seems to be related to location alone and not to size.The amount of apoptosis and proliferation can be used as additional criteria in the differentiation between superficial LMS and LM.