Oral mucositis management with photobiomodulation, Bidens pilosa L. (Asteraceae) and Curcuma longa L. (Zingiberaceae), the FITOPROT herbal medicine, and its influence on inflammatory cytokine levels: a randomized clinical trial.

PURPOSE: This randomized clinical trial aimed to compare the effects of a mucoadhesive formula, containing curcuminoids from Curcuma longa L. and glycerinated extract of Bidens pilosa L. (FITOPROT), associated with photobiomodulation (PBM), and of PBM exclusively, on the incidence of oral mucositis (OM)-induced by radiotherapy (RT) in the head and neck region, and the salivary expression of inflammatory cytokines, in patients with head neck cancer. METHODS: Patients were randomly assigned into two intervention groups-FITOPROT + PBM (n = 25) or PBM (n = 27). PBM protocol comprised a wavelength of 660 nm, 25 mW, 0.25 J/point, and daily irradiation from the first until the last day of RT. FITOPROT was gargled twice a day. All patients underwent a preventive oral care program throughout the study. OM degree, salivary concentration of nitrite, and inflammatory (IL-1, TNFα, IL-6, IL-8, and IL-12p70), and anti-inflammatory (IL-10) cytokines were assessed at baseline, and at the 7th, 14th, 21st, and 30th RT sessions. RESULTS: There were no differences in the OM degree between groups, but the RT dose significantly affected the OM. The RT significantly affected the salivary nitrite, TNFα, IL-1ß, and IL-10 concentrations. CONCLUSION: FITOPROT associated with PBM showed limited effects on preventing the incidence of severe OM compared to PBM alone. However, FITOPROT + PBM may be associated with nitrite and cytokine balance, which may contribute to the occurrence of fewer cases of severe OM. TRIAL REGISTRATION: Brazilian Clinical Trials database (ReBEC; RBR-9vddmr), registered UTN code: U1111-1193-2066, registered in August 8th, 2017.

Mandibular overdentures retained by 1 or 2 implants: a 5-year randomized clinical trial on implant stability and peri-implant outcomes.

AIM: This is a report of the 5-year results of a two-group parallel randomized clinical trial comparing longitudinal implant stability, and clinical and radiographic peri-implant outcomes of mandibular overdentures retained by one (1-IOD group) or two (2-IOD group) implants. METHODS: All participants received 4.1 mm diameter tissue-level implants (Straumann® Standard Plus - SLActive®, Institut Straumann AG), installed in the mandible midline (1-IOD; n = 23) or the lateral incisor-canine area bilaterally (2-IOD; n = 24), and loaded after 3 weeks. Implant Stability Quotient (ISQ) was measured using a resonance frequency device (Osstell® Mentor, Integration Diagnostics) at implant placement, after three weeks (loading), and at the 6-month, 1-, 3-, and 5-year follow-ups. Marginal bone loss and clinical implant outcomes (plaque, calculus, suppuration and bleeding) were assessed periodically up to 5 years after loading. RESULTS: Only minor changes in marginal bone level were observed after 5 years (mean = 0.37; SD = 0.44 mm), and satisfactory and stable peri-implant parameters were observed throughout the 5-year follow-up. No significant differences between groups were found. Overall, the mean primary implant stability was considered high (> 70) for the two groups (1-IOD = 78.1 ± 4.5; 2-IOD = 78.0 ± 5.8). No noticeable changes were observed between implant insertion and loading. A marked increase was observed from insertion to the 6-month follow-up - the mean difference for the 1-IOD group was + 5.5 ± 5.5 (Effect size = 1.00), while for the 2-IOD group, the mean difference was + 6.0 ± 5.6 (Effect size = 1.08). No relevant changes were observed throughout the follow-up periods up to 5 years. Linear mixed-effect model regression showed no influence of the bone-related variables (p > 0.05) and the number of implants (p = 0.087), and a significant effect of the time variable (p < 0.001). CONCLUSION: Satisfactory peri-implant outcomes and stable secondary stability suggest good clinical performance and successful long-term osseointegration of the implants for single and two-implant mandibular overdentures. Using a single implant to retain a mandibular overdenture does not seem to result in detrimental implant loading over the five years of overdenture use. CLINICAL RELEVANCE: This study corroborates the use of a single implant to retain a mandibular denture.

Prolonged use of old dentures: A qualitative study with Brazilian older adults.

OBJECTIVE: To explore older adults' perceptions, motivations and reasons for using and not replacing old and worn complete dentures over prolonged periods. MATERIALS AND METHODS: In-depth, semi-structured interviews were conducted with Brazilian edentulous older adults who were wearing complete dentures which were at least 20 years old. A purposive sampling method was used to recruit participants from an existing waiting list of those referred to a hospital clinic for new dentures. The interviews were video-recorded, transcribed verbatim and analysed using thematic analysis. RESULTS: Sixty-two individuals were assessed and nine were included in the study, aged from 61 to 77 years (mean = 65.4), with seven (77.8%) of them women. The reported time using their current dentures ranged from 22 to 45 years (mean = 28). Content analysis revealed three main themes: the perception of the current dentures' condition after prolonged use; reasons for the prolonged use and non-replacement; and unsuccessful attempts to replace the dentures. Overall, participants acknowledged the poor condition of their dentures and did recognise the need for replacement. Several factors had prompted them to delay or temporarily forego replacement, with financial constraints being the main barrier. Some reported failed attempts to replace the dentures in the past years or months; however, challenging adaptation to the new prostheses led to them reverting back to their old dentures as a fallback solution. CONCLUSION: Factors influencing prolonged denture use in older adults include a complex interplay of financial aspects, treatment awareness, access and personal factors. Dental professionals can play a pivotal role in promoting timely denture adjustment or replacement by addressing these factors through patient education and personalised care.

Mandibular overdenture retained by four one-piece titanium-zirconium mini implants: A 2-year RCT on patient-reported outcomes.

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.

Mandibular overdenture retained by four one-piece titanium-zirconium mini implants: A 2-year follow-up on prosthodontic outcomes.

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.

A cross-sectional CBCT assessment of the relative position of one-piece titanium-zirconium mini-implants placed for mandibular overdentures using non-guided surgery.

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.

Topographical and histological analysis of keratinized mucosal grafts removal techniques an ex-vivo study in porcine mandibles.

The aim of this study was to assess the surface and tissue quality of keratinized mucosa grafts (KMG) obtained using the conventional scalpel and mucotome techniques. This was an experimental in vitro/ex vivo study involving six porcine hemi-mandibles. Specimens were harvested using both the mucotome and conventional scalpel techniques, with randomization determining the choice of technique for tissue removal. The specimens were prepared following predefined laboratory protocols and subsequently subjected to optical microscopy for evaluating epithelial and connective tissue and scanning electron microscopy for topographical and 3D profilometry analysis. Tissues harvested using the mucotome exhibited a linear base and uniform thickness, along with the presence of submucosa and fibrous connective tissue, all of which are ideal for graft success. Differences in the surface characteristics of specimens obtained through the two techniques were observed during a comparative analysis of images obtained through both microscopy types. KMG obtained using the mucotome technique displayed greater uniformity and reduced undesirable cell presence compared to the scalpel technique, thereby enhancing the likelihood of success in soft tissue graft surgical procedures. This study provides valuable insights to oral healthcare professionals and may contribute to future research aimed at achieving more successful surgeries, shorter postoperative recovery times, reduced discomfort, and an overall more positive patient experience.

Mandibular overdenture with a single implant in the canine region (c-SIMO): a feasibility study.

OBJECTIVES: The aim of this multi-center pilot study was to assess the viability and feasibility of a novel treatment concept - the canine-positioned single implant mandibular overdenture (c-SIMO), with the single implant placed on the patient's preferred chewing side instead of the midline. MATERIALS AND METHODS: Participants received a single implant in the canine region of their preferred chewing side, based on an Asymmetry Index observed during mastication. The pre-existing mandibular denture was transformed into a c-SIMO on a spherical attachment. The primary outcome was oral health-related quality of life (OHRQoL), measured with GOHAI and OHIP-EDENT. Secondary outcomes included denture satisfaction index (DSI), chewing efficiency (CE), maximum bite force (MBF), implant survival and success, and prosthetic maintenance. Data analysis included descriptive statistics and bivariate comparison tests. RESULTS: Fifteen participants received the c-SIMO treatment (mean age: 69.9 ± 7.0). Implant success and survival rates were 100% at 1 year. Patient-reported outcome measures improved significantly compared to pre-treatment values (OHIP-EDENT: p = 0.001; DSI: p = 0.001; GOHAI: p = 0.002). Masticatory outcomes also improved significantly (CE: p = 0.001; overall MBF: p = 0.005). Post-implant, MBF was significantly higher in the ipsilateral side compared to the contralateral side at 2 weeks (p = 0.019) and 3 months (p = 0.015), but no longer at T3 (p = 0.730). Common prosthodontic events included denture base adjustments (n = 17) and matrix activation (n = 9). CONCLUSIONS: This pilot study concludes that c-SIMO is a promising treatment option, and a potential alternative to the single midline implant overdenture. CLINICAL RELEVANCE: The novel treatment concept of a canine-positioned single implant mandibular overdenture could be a viable treatment alternative to the midline positioning.

The association between referral by specialists in oral diagnosis on survival rates of patients with oral cancer: A retrospective cohort study.

BACKGROUND: To assess the influence of diagnosis and referral provided by specialists in oral diagnosis on disease-free survival and overall survival of patients with oral cancer. METHODS: A cohort of 282 patients with oral cancer treated at a regional cancer hospital from 1998 to 2016 was analyzed retrospectively. The referral register of the patients was analyzed and assigned to two groups: (1) those referred by oral diagnosis specialists (n = 129), or (2) those referred by nonspecialized professionals (n = 153). The cancer treatment evolution was assessed from the patients' records, and the outcome was registered concerning cancer recurrence and death. Sociodemographic and clinicopathological variables were explored as predictors of disease-free survival and overall survival. RESULTS: Group 1 exhibited lower T stages and a reduced incidence of regional and distant metastases. Surgery was performed in 75.2% of cases in Group 1, while in Group 2, the rate was 60.8%. Advanced T stages and regional metastases reduced the feasibility of surgery. Higher TNM stages and tumor recurrence were associated with decreased disease-free survival, while surgical intervention was a protective factor. Higher TNM stage had a negative impact on the overall survival. CONCLUSION: Specialized oral diagnosis did not directly impact disease-free survival and overall survival and did not influence the indication of surgery in oral cancer; however, it was associated with the diagnosis of early tumors and better prognosis.

Reliability of a face scanner in measuring the vertical dimension of occlusion.

OBJECTIVE: This study evaluated the reliability of a face scanner in measuring the vertical dimension of occlusion (VDO). METHODS: Fully dentate volunteers (n = 20; mean-age = 30.0 ± 10.7 years) were recruited. Clinical facial measurements were obtained using a digital caliper and a face scanner (Obiscanner, Fifthingenium, Italy). The scans were imported into a mesh-processing software, and the distances were measured digitally. Measurements were obtained for each participant with the jaws positioned in maximal intercuspation (MI) and with increased vertical distances of 2, 4, and 6 mm. Vertical and horizontal measures were obtained using facial anatomical landmarks: Glabella (GL), Pronasale (PrN), Subnasale (SbN), inferior border of the right and left Alare, Labiale superius (Ls), right and left Cheilion (Ch), Soft Pogonion (SPg), right and left Tragus of the ear (Tr), for all selected vertical positions. Data analysis included intra-class correlation coefficient (ICC), pairwise comparison tests, Bland-Altman plots, and Passing-Bablok regression. RESULTS: 120 VDO measurements (clinical=60, digital=60) were recorded by two independent evaluators. Mean differences between digital and clinical measurements ranged from 0.054 ± 0.14 mm to 0.203 ± 0.13 mm. All parameters were strongly correlated (r > 0.93; p < 0.001). ICC estimates revealed excellent reliability, and the measuring procedure yielded the same results on repeated trials irrespective of the raters and measurement methods. Bland-Altman plots revealed a difference, between digital and clinical measurements, of 1.7 % for the vertical measurements. Regression analysis revealed no significant proportional difference between the two methods, so both can be used interchangeably. CONCLUSIONS: The findings of this study demonstrate that VDO can be measured accurately from face scans using 3D mesh-processing software and that even small changes in the VDO could be detected using the digital methods. CLINICAL SIGNIFICANCE: Findings provide evidence about the reliability of a digital method for jaw relation registrations and may be applied towards incorporating this method into clinical workflows for computer-aided-design/ computer-assisted-manufacturing (CAD-CAM) dentures.

Changes in masticatory performance and bite force after treatment with mandibular overdentures retained by four titanium-zirconium mini implants: One-year randomised clinical trial.

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.

A 1-Year Parallel-Group Randomized Clinical Trial Comparing the Effectiveness of a Mandibular Complete Denture vs an Early Loaded Single-Implant Overdenture.

PURPOSE: To assess the effectiveness of converting a conventional mandibular denture (CMD) into a single-implant mandibular overdenture (SIMO). MATERIALS AND METHODS: Edentulous patients received a new CMD and were randomly assigned to the CMD or SIMO group. For SIMO patients, a midline early-loaded implant was inserted and incorporated into the CMD after 3 weeks. Patient satisfaction and oral health-related quality of life were assessed at baseline and up to 1 year. Regression models were constructed using Generalized Estimating Equation (GEE). RESULTS: After 12 months, 32 patients were assessed (CMD: n = 17; SIMO: n = 15). Significant improvement was observed for the SIMO group compared to baseline measures. CONCLUSIONS: SIMO may be considered an effective alternative for patients unsatisfied with their CMDs.

Single lateral implant for mandibular overdentures as a fallback solution or a viable treatment alternative: Four case reports.

This report of four clinical cases aims to illustrate the use of a lateral implant as a solution for implant overdentures in the mandible in different clinical situations. The first two cases describe the clinical situations of patients wearing two-implant mandibular overdentures until the failure of one of the implants, one due to implant loss and the other due to a fracture of an abutment screw, and how the conditions were managed. The third case illustrates the placement of a single implant to retain an overdenture, where a midline implant, as originally planned, was not feasible due to anatomic reasons. The final case describes the use of a lateral implant to support and retain a single-implant mandibular overdenture. The four cases demonstrate that a single lateral implant can be utilized as sole retention in cases of a failing contra-lateral implant and as an alternative to a single implant in the midline.

Reliability between the two-colour chewing gum and the gummy-jelly tests used for the assessment of masticatory performance.

OBJECTIVE: This study aimed to evaluate the reliability of two methods used to assess masticatory performance and attempt to correlate them to achieve interchangeability between the methods. METHODS: Twelve healthy dentate volunteers (men = 6, women = 6; mean age = 28.3 ± 4.1) with no known dental or medical pathologies were requested to participate in this study. Each participant completed three masticatory performance assessments, including two two-colour mixing-ability tests using chewing-gums (CG: gum#1 and gum#2) and the gummy-jelly (GJ) test. For each method, participants created five samples each (total = 15 measurements per participant, gum#1 = 5, gum#2 = 5, GJ = 5). For the gum#1 and gum#2 methods, the predetermined chewing cycles were fixed at 10, 15, 20, 25 and 30 cycles, and for the GJ method, the time duration was fixed at 10, 15, 20, 25 and 30 s. The parameter measures were submitted to Z-score transformation, and Bland-Altman plots were generated to graphically compare the differences between two techniques against their means. Additionally, mountain plot was used to assess the cumulative distribution of measurement error between the methods. RESULTS: A total of 180 measurements were recorded. There were significant correlations between the number of chewing cycles/chewing time and masticatory performance using the gum#1 (r = -.753; p < .001), gum#2 (r = -.838; p < .001) and GJ (r = .730). When all tests were considered together for each method, significant correlations were found (p < .001). A descriptive range of mean values aiming to produce reference value ranges for predictive purposes was achieved considering the interchangeably among the methods [CG = GJ (VoH-mg = dL): 10 cycle = 10 s: 0.329 = 110; 15 cycles = 15 s: 0.177 = 164; 20 cycles = 20 s: 0.130 = 205; 25 cycles = 25 s: 0.086 = 200; 30 cycles = 30 s: 0.077 = 267]. CONCLUSION: The strong correlations and high consistency between the two masticatory performance methods found in this study conclude that the two assessment methods are reliable and interchangeable. Further evaluations are warranted to arrive at a conversion formula for translation of the results between the two methods.

Effects of a mucoadhesive phytomedicine (Curcuma longa L. and Bidens pilosa L.) on radiotherapy-induced oral mucositis and quality of life of patients undergoing head and neck cancer treatment: randomized clinical trial.

PURPOSE: To assess the effect of a mucoadhesive herbal medicine containing curcuminoids and a glycerinated extract of Bidens pilosa L. (FITOPROT) in association with photobiomodulation (PBM) therapy and a Preventive Oral Care Program (POCP) compared to PBM and POCP in the treatment of radiotherapy (RT)-induced oral mucositis (ROM) and in the quality of life of these patients. METHODS: A double-blind clinical trial was performed with head and neck cancer patients undergoing RT or chemoradiotherapy. Participants were randomized into two groups: Group 1 (n=27): PBM and POCP; and Group 2 (n=25): PBM, POCP and FITOPROT. The PBM protocol was daily irradiation, 660 nm, 25mW, 0.25 J/point from the first until the last day of RT. The FITOPROT was used as mouthwash twice a day. ROM was evaluated based on the scales of the World Health Organization and National Cancer Institute. The quality of life was evaluated using the University of Washington Questionnaire, OHIP-14 and Patient-Reported Oral Mucositis Symptom Scale. The MMAS-8 questionnaire was used to evaluated the adherence to POCP and FITOPROT. Data were collected at baseline, 7th, 14th, 21st, and 30th RT sessions. RESULTS: No statistical differences were found between the groups for the ROM evaluation. Both groups experienced worsening of the quality of life during the RT. No statistically significant differences between groups were observed for any of the instruments evaluated. CONCLUSION: The results suggest that PBM associated with FITOPROT and POCP control the severity of ROM and stabilize the QoL of patients with head and neck cancer. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC-RBR-9vddmr; UTN code: U1111-1193-2066), registered in August 8th, 2017.

Implant survival/success and peri-implant outcomes of titanium-zirconium mini implants for mandibular overdentures: Results from a 1-year randomized clinical trial.

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.

Willingness to accept or refuse mandibular implant overdenture treatment: A prospective study on edentulous enrolled in a clinical trial.

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.

Prosthodontic outcomes of mandibular overdenture treatment with one or two implants: 4-year results of a randomized clinical trial.

OBJECTIVE: To assess the incidence of prosthodontic maintenance events and complications during 4 years of follow-up after mandibular overdenture treatment with one or two implants. METHODS: Participants received one or two implants inserted in the midline (1-IOD group) or the lateral incisor-canine area bilaterally (2-IOD group). Implants were loaded with an early loading protocol after 3 weeks. Programmed recall visits were scheduled at the 6-, 12-, 36-, and 48-month follow-ups and nonprogrammed visits in case of prosthodontic complaints. The type of maintenance was registered, and the final treatment outcome was classified as successful, surviving, unknown, dead, repair, or retreatment. RESULTS: Forty-seven participants, mean age 65.4 ± 8.6, 74.5% female, were included (1-IOD = 23; 2-IOD = 24) and 44 completed the 4-year follow-up. A total of 159 prosthodontic maintenance events occurred and 89 in unscheduled visits. The most common event was the need for minor modifications of the denture base due to sore spots in the oral mucosa (n = 56 in 31 patients), matrix activation (n = 54 in 34 patients), and overdenture fracture (n = 25 in 18 patients). A "successful" or "surviving" outcome could be attributed to 57.5% of cases, whereas 38.3% needed repair. No significant differences in the incidence of prosthodontic events or treatment outcomes were found between the two groups. CONCLUSIONS: Findings show that 1-IODs perform similar to 2-IODs when considering the incidence of fractures and the need for prosthodontic maintenance, including adjustments of the overdenture and the attachment system.

Mandibular bone characteristics, drilling protocols, and final insertion torque for titanium-zirconium mini-implants for overdentures: A cross-sectional analysis.

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.

Expected and perceived burdens in patients receiving mandibular overdentures retained by one or two implants.

PURPOSE: This study aimed to assess patients' expected burdens before treatment and their perceived burdens after the surgical and prosthodontic procedures of mandibular overdenture treatment and to evaluate factors influencing patients' perceptions. METHODS: Data were collected from 47 participants enrolled in a randomized clinical trial comparing mandibular overdentures retained by one or two implants. A 20-item questionnaire measured on a four-point Likert scale covering the surgical and prosthetic treatment procedures was used to assess the patients' perception of the procedural burdens before (expected burdens) and immediately after (experienced burdens) each procedure. Operators' perceptions of intercurrences associated with the procedures were also assessed as an independent variable. RESULTS: Low levels of perceived burdens were observed both before and after treatment. The mean overall scores of 1.65 ± 0.46 and 1.53 ± 0.33 for expected and experienced burdens, respectively, indicated that most items ranged between "not burdensome at all" and "somewhat burdensome." Significant differences between expected and experienced burdens were found for eight items (P < 0.001). Considering the treatment stages, expected burdens scored higher in the pre-surgical, surgical, and prosthetic stages and lower in the post-surgical phase than experienced burdens. Overall, the experienced burdens were significantly affected by the expected burdens (P < 0.001) and operator's perceived burdens(P = 0.045). CONCLUSIONS: Treatments were associated with low levels of perceived burdens related to surgical and prosthodontic procedures and were highly correlated with the expected burdens before treatment. However, patients tend to overestimate the expected burdens before treatment, especially for surgical procedures.