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OBJECTIVE: To assess the relative position of mini-implants to retain a mandibular overdenture, according to the surgical protocol, technical and anatomical factors. METHODS: Mandibular cone-beam computed tomography (CBCT) scans were analyzed for 73 patients who received four one-piece titanium-zirconium mini-implants. Drilling was performed using a 1.6 mm needle drill and a 2.2 mm Pilot Drill, according to the bone density with a surgical stent. Post-insertion CBCT images in DICOM format were analyzed using the E-Vol-DX software with BAR filters. Divergence angle between implants and between implants and the overdenture path of insertion was measured using CliniView 10.2.6 software. RESULTS: Divergence between implants ranged from 0° to 22.3° (mean = 4.2; SD = 3.7) in the lateral and from 0° to 26.2° (mean = 5.3; SD = 4.1) in the frontal projections (p < .001). Only 1 (0.2%) and 3 (0.7%) of the measurements were higher than 20° in the lateral and frontal views, respectively. The mean angulations between the implant and the path of insertion for the overdenture were 9.3° (SD = 7.5) and 4.0° (SD = 2.9) for the lateral and frontal views, respectively (p < .001). Regression analyses showed a significant association between the divergence of implants and the frontal view projection (p < .001), greater distance between the paired implants (p = .017), the flapped surgical protocol (p = .002), higher final insertion torque (p = .011), and deeper preparation with the needle drill (p < .001). CONCLUSIONS: The mini-implants were placed with low divergence angles and satisfactory parallelism. Factors including shorter distances between the implants, higher density bone, and a flapless surgical approach all contributed positively to improved parallelism of the mini-implants.

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AIM: The positive impact of implant interventions on dental patient-reported outcomes is an essential parameter of treatment effectiveness. This study assessed the 2-year changes in patient satisfaction and oral health-related quality of life (OHRQoL) of edentulous patients treated with a four mini implant mandibular overdenture (IOD) METHODS: The study was planned as a 2 × 2 factorial randomized clinical trial that tested two surgical approaches (flapped or flapless) and two loading protocols (immediate and delayed) using a titanium-zirconium mini implant (Straumann Mini Implant System®) and a PEEK retentive system (Straumann® Optiloc® Retentive System). Outcome measures (OHIP-Edent scores and the McGill Denture Satisfaction questionnaire) were assessed before treatment and at the 3-, 6-, 12-, and 24-month follow-ups. The Friedman test and multiple regression using Generalized Estimating Equations (GEE) were used for data analysis, considering the per-protocol (PP) and intention-to-treat (ITT) approaches RESULTS: Seventy-four patients were randomized to the study groups. No implant failure occurred during the study period. Marked improvement in all post-treatment periods compared to baseline were observed for the two outcomes. No significant effect of patient's gender, age, and surgical protocol on the study outcomes. The effect of treatment provision was significant for the two outcomes in the PP and ITT approaches (p < 0.001). A barely significant positive effect of the immediate loading was observed for OHIP-Edent in the PP approach (p = 0.020) CONCLUSION: IOD treatment significantly improved patient-reported outcomes measures, with sustained benefits over the two years of overdenture use, and can be considered a promising treatment option in for the edentulous mandible.

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OBJECTIVE: This 2-year prospective study reports the incidence of prosthetic complications and maintenance events after treatment with mandibular overdenture retained by four mini implants opposed to a maxillary denture. METHODS: Implant intervention included flapless or flapped surgery combined with immediate or delayed loading, as part of a randomized clinical trial. Four one-piece titanium-zirconium mini-implants (Straumann Mini Implant System) were inserted, and the retentive PEEK elements (Optiloc) were incorporated into the overdenture using chairside procedures. Prosthodontic complications and maintenance events were recorded over a 2-year follow-up, and the final outcome was defined according to standardized criteria. Data analysis included descriptive statistics, incidence and incidence density rates, and Kaplan-Meier survival. RESULTS: 73 out of 74 patients (64.9 % female), mean age of 64 (SD=8.2) years, completed the study follow-up (one withdrew after 9 months). Implant survival was 100 %. A total of 163 prosthodontic events occurred in 53 patients (72.6 %), and 20 patients had no clinical complaints or maintenance needs. The most common procedures were adjustment/repair of the overdenture base (47.0 %), replacement of retentive inserts (19.8 %), and laboratory relining (12.9 %). A high prosthodontic success rate was achieved (93.2 %), and all patients presented serviceable overdentures and continuous use after the resolution of prosthodontic complications. The incidences of matrix replacement and laboratory relines were low in the first year, while denture base adjustments were common within the first year, especially in the first 6 months. CONCLUSION: The mini implant system showed high prosthodontic success rates. Minor adjustments/repairs during the initial follow-up were common. Relines and matrix replacements tend to occur after one year of overdenture use, and matrix replacements may occur as a consequence of the need for relining.

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OBJECTIVE: This prospective study is part of a randomised clinical trial and reports the changes in masticatory performance (MP) and bite force, and explores their influential factors, 1 year after the provision of mandibular overdentures retained by four titanium-zirconium mini implants. METHODS: Edentulous patients received conventional complete dentures, followed by placement of four mini implants (Straumann® Mini Implant System) in the anterior mandible and converting the conventional prosthesis into a mandibular overdenture. Treatment protocols were randomised using a 2×2 factorial design combining different surgical (flapped vs. flapless) and loading (immediate vs. delayed) protocols. MP was assessed using a two-colour mixing ability test and a colorimetric analysis to measure the level of colour mixing (Variance of Hue-VoH). Maximum voluntary bite force (MBF) was measured by a digital gnathodynamometer in the posterior and anterior regions. Sex, age, surgical and loading protocols and ridge morphology were tested as independent variables. MP and MBF tests were performed at baseline (pre-treatment) and the 3-, 6- and 12-month after implant loading. Descriptive statistics, independent t-test, and linear mixed-effect model (LMM) regression were used for data analysis. RESULTS: Seventy-four participants were assessed and 73 completed the 1-year follow-up. Statistically significant improvements in functional parameters were observed in all follow-up periods compared to baseline (p < .001). The flapless protocol was associated with higher improvement in MP at the 3-month follow-up (p = .004), while less resorbed ridges were associated with better MP (p = .038) and higher MBF (p < .001). CONCLUSION: The mandibular overdenture protocol using four titanium-zirconium mini implants was effective in improving MP and MBF of edentulous patients, compared to pre-treatment values. The findings also suggest that improvements in chewing function and bite force are impacted by clinical factors since better outcomes were observed for flapless surgeries and less resorbed edentulous ridges. CLINICAL TRIAL REGISTRATION: ClinicalTrials.Gov ID NCT04760457.

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OBJECTIVE: To report the 1-year implant survival/success and peri-implant outcomes of mandibular overdentures retained by four titanium-zirconium mini implants (Straumann® Mini Implant System), and to assess how surgery and loading protocols influence these outcomes. MATERIALS AND METHODS: A 2 × 2 factorial randomized clinical trial (RCT) tested the combined effects of two loading protocols (immediate or delayed) and two surgical approaches (flapless or flapped) on the success/survival of the mini implants, and peri-implant parameters (plaque, bleeding, sulcus depth, gingival position, and marginal bone loss). Outcomes were assessed up to 1-year after loading, and generalized estimating equations (GEEs) were used to analyze longitudinal and within-patient clustered data. RESULTS: Two hundred and ninety-six implants were placed in 74 patients. The implant survival/success rates after 1 year were 100%, and no major biological complications were observed. After 1-year, descriptive data suggest no noticeable changes in plaque scores, whilst a reduction in bleeding scores at the 6-month and 1-year follow-ups compared to baseline. Good longitudinal stability was observed for the probing depth and gingival margin height measures. Overall mean marginal bone loss was 0.68 (±0.68) mm after 3 months and 0.89 (±0.75) mm after 1-year. The flapless protocol showed better results on soft tissue stability and health but a slightly higher risk for marginal bone loss. CONCLUSION: The results of this RCT suggest that mandibular overdentures retained by this novel mini implant system represent a safe and predictable treatment option as confirmed by implant survival/success and peri-implant outcomes, even when flapless surgery and immediate loading protocols are adopted.

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BACKGROUND: Several complete denture wearers have major complaints and may be benefitted from implant treatment. However, the factors that shape the demand for and utilization of implants need further investigation. OBJECTIVE: The aim was to evaluate edentulous patient's willingness to accept or refuse the offer and provision of implant-retained treatment. METHODS: As part of a clinical trial, edentulous subjects were offered a mandibular overdenture retained by four mini-implants opposing a conventional maxillary denture. Treatment was offered without any financial costs for the patients. Patients' level of interest in receiving treatment was assessed using a 5-point Likert scale, and they were asked to respond to a list of reasons that led to their decision to accept or refuse implants. Those who refused implants received conventional prosthodontic interventions as required, and those who accepted implant treatment underwent surgical planning and implant placement. RESULTS: Of 175 eligible subjects, 147 accepted the offer of treatment and were invited to take part in the study (69.4% women, mean age 67.4 ± 10.0 years). Overall, 111 patients (75.5%) expressed a positive intention to undergo implant treatment at the initial contact. Implant treatment was performed for 56.3% (9/16) of those who answered 'probably yes' about their level of interest in implant treatment on the Likert scale, and 69.6% (64/92) of 'certainly yes' (p < .001). Older subjects were less likely to receive implants (OR = 0.93; p = .036), whilst those with a positive intention towards implants (OR = 3.15; p = .001), those previously treated by the dental team (OR = 7.89; p < .001), and who actively demanded implants (OR = 18.1; p < .001) were more likely to accept treatment. Improved chewing was the most common reason for accepting implants, whilst fear of surgery was the most reported reason for refusal. CONCLUSION: Refusal of implants was high among edentate patients even when financial costs were removed. Patients' initial attitude towards acceptance is a key factor in the demand for and uptake of implant therapy.

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OBJECTIVE: The aim of this study was to assess the final insertion torque values achieved using site-specific drilling protocols for a novel mini implant system for removable complete overdentures. Anatomical and technical factors influencing final insertion torque were recorded and analyzed. MATERIAL AND METHODS: Participants were randomized to two surgical protocol groups (flapped or flapless) and all received four mini implants (Straumann® mini implant system; Straumann AG) in the anterior mandible, using a 1.6 mm needle drill and a 2.2 mm pilot drill for the implant bed site preparation. The final insertion torque was recorded as the main outcome variable during surgery. Bone type, radiographical bone density, ridge form, implant length, and the drilling protocol were considered as independent variables. Descriptive statistics, generalized estimating equations (GEE) regression, and heatmap charts were used for data analyses. RESULTS: A total of 296 mini implants were placed in 74 patients (mean age = 64.1 ± 8.0; 64.9% female) using flapless (n = 37) or flapped (n = 37) surgeries. Mean final insertion torque was 55.8 ± 18.4 Ncm (10.5% > 35 Ncm, 48.9% between 35 and 65 Ncm, and 40.6% > 65 Ncm). The needle drill was used in only 43.9% of the implant bed sites. Higher final torque values were observed for higher bone densities (bone type I > II > III, and D1-D2 > D3-D4), highly resorbed ridge forms (5-6 > 3-4), flapped surgeries, and male patients. However, regression models showed that the likelihood of achieving optimal insertion torque (≥35 and ≤65 Ncm) was higher for females (OR = 2.14; 95%CI = 1.14-4.01; p = 0.018), ridge forms 3-4 (OR = 2.87; 95%CI = 1.05-7.85; p = 0.040), and flapless surgeries (OR = 1.96; 95%CI = 1.09-3.51; p = 0.024). CONCLUSIONS: Sufficient primary stability for immediate loading was achieved for the majority of the mini implants placed. Surgical implant bed preparation should be site-specific to achieve optimal primary stability for immediate loading while avoiding excessive insertion torque.

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OBJECTIVE: This factorial randomized clinical trial (RCT) tested the effects of the surgical approach (flapped-FPS vs. flapless-FLS surgery) and loading protocol (delayed-DL vs. immediate-IL) for treatment with a four mini implant mandibular overdenture. MATERIAL AND METHODS: A total of 296 one-piece titanium-zirconium mini-implants were inserted in 74 patients (IL/FLS = 17; IL/FPS = 18; DL/FLS = 20; and DL/FPS = 19). Outcomes included patient's perceived surgical burdens, clinical time, implant survival, and post-surgical symptoms and complications, assessed immediately after surgery, in the 7-day and 6-week follow-ups. RESULTS: Perceived surgical burdens were relatively low, higher for females, and no difference was found between FPS and FLS surgery. Surgical time was lower for FLS surgery. Overall symptoms were mild after 24 h, and higher for females. Less symptoms were recorded for the FLS surgery compared to the FPS for the delayed loading patients, and FLS surgery was associated with a lower risk of bleeding. No early implant failure was observed until the 6-week follow-up. Delayed was associated with discontinuous use of the prosthesis and poor function. Lower complaint rates were observed for immediate loading regardless of the surgery protocol. CONCLUSIONS: Mini implants for mandibular overdenture are a feasible option regardless of surgical access and loading protocol, with high safety and predictable survival rates, and low incidence of post-insertion complications. FLS surgery requires less clinical time and results in easier intraoral prosthetic incorporation of attachments compared to FPS surgeries. Immediate loading did not increase the risk of early implant failure when satisfactory primary stability was achieved.

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Oral health problems are associated with poor quality of life, with the potential to cause functional, aesthetic, nutritional, and psychological difficulties, in addition to pain and suffering. Traditionally, dental treatment outcomes are measured using purely clinical parameters; however, this may be ineffective as these parameters cannot adequately capture the full impact of poor oral health on the patient, or their respective coping strategies. From this perspective, there are significant benefits when the patient's perception of their care is considered, and included in treatment planning and delivery. The impacts perceived by the patient on their treatment outcomes can be measured using patient-reported outcomes (PROS), or more specifically with dPROS, focused on dental patient-reported outcomes. Although there are some instruments available for measuring these outcomes in clinical trials, very little information is available for explaining the context in which these outcomes are considered, and also how to capture this information using appropriate instruments, specially in evidence-based dental practice. This article aims to review the literature, seeking to describe what has been considered about assessing patient's outcomes, as well as how to measure them, and explore the potential benefits of using dPROS in evidence-based prosthodontics and clinical care of partially and fully edentulous patients.

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BACKGROUND: In recent years, the single-implant mandibular overdenture (SIMO) has been proposed as an alternative to more complex overdenture designs as a simplified implant intervention for edentulous patients. OBJECTIVE: The aim of this study was to run a cost-effectiveness analysis alongside a randomized clinical trial comparing the SIMO and the conventional complete denture (CCD) treatment. Imediately loaded external hexagon implant and ball attachment were used for the overdenture goup. Direct costs related to therapies were identified and valuated throughout a 1-year period after delivery, in Brazilian currency (R$) and converted into international dollars (I$) using purchase power parity exchange rates. Treatment effectiveness was measured using the OHIP-Edent and satisfaction scores for calculation of incremental cost-effectiveness ratios (ICER). RESULTS: Outcomes were assessed at the 1-year follow-up for 65 patients (CCD=34; SIMO=31). Overall OHIP-Edent and satisfaction scores improved significantly in the SIMO group, while remained unchanged in the CCD group. The mean overall costs were R$1,179.04 (I$590.99) for the CCD group and R$2,127.91 (I$1,068.20) for the SIMO group - 80.7% incremental cost for SIMO. The ICER calculation for SIMO treatment showed a mean cost of I$48.20 for 1-point reduction in OHIP-Edent scores, and I$12.56 for 1-point increase in satisfaction score. CONCLUSIONS: Findings support the effectiveness of this simplified and low-cost implant intervention for edentulous patients. SIMO also seems a cost-effective alternative to the CCD and the relatively low incremental cost may potentially increase the utilization of dental implants among older subjects, especially those with limited financial resources. CLINICAL SIGNIFICANCE: The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.

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