Additional Augmentation Procedures Research Articles

(229) A Pilot Study of a Novel PRP Protocol to Increase Penile Length, Girth, and Function

Abstract Introduction A study of a novel PRP protocol to increase penile length, girth, and function Intro: Various solutions have been utilized to increase penis size, including fillers, fat transfers, traction devices, suspensory ligament ligation, and silicon augmentation. None of these improve length, girth, function and are completely safe. PRP is an autologous source of growth factors. The RestoreX is a well-studied traction device. Vacuum erection devices provide a stimulus for circumferential penile growth. Nitric Oxide boosters improve blood flow and nighttime erections. Objective The P-Long Study aims to find a safe and reproducible way to increase the length, girth, and function of a normal male penis. Methods The study is IRB approved and patient consented. Inclusion criteria: healthy men aged 20 to 55 with normal erectile function (SHIM greater than 22) and no Peyronie’s Disease, previous penile interventions, or congenital penile issues. Measurement of penile length and girth were performed by the patient on an erect penis during self-stimulation at full tumescence with standard protocol and measuring instruments (transparent rigid ruler and flexible tape measure) and documented with digital images. No PDE-5 inhibitors or Trimix were used. Measurements were taken at baseline and once a month for six months. PRP was administered in the right and left corpora under ultrasound guidance once a month for six months using PureSpin double spin system (60cc blood drawn) Centrifuge technical data show an average platelet recovery of 84% and average concentration of 6.6 times that of the whole blood sample. Using this data, the injection of 10cc of PRP, assuming a starting platelet count of 250K/microliter, would contain approximately 1.65 billion platelets. Traction with RestoreX 20 minutes bid and suction with Joel Kaplan penis pump (pressure 5-10 for 12 minutes bid (1 minute x 2 and 5 minutes x 2.) Nitric Oxide boosting supplement (trade name AFFIRM) with a dose of 3 gm L-Citrulline and 1 gm beet extract (nitrate). Results 29 men have completed treatment. The mean age was 32 and mean baseline erect penile length was 5.70 and girth was 5.25. Erect penis length was 0.805 inch greater after six months from baseline (N=29, paired t-test t=13.641 p value=0.000). Circumference was 0.469 inch greater (N=29, paired t-test t=13.498 p value=0.000). Using a Likert scale, all participants reported better erectile function. Conclusions The P-Long Protocol is potentially a safe way to improve erect penile length 0.81 inches and girth 0.47 inches over a period of six months and subjectively improve function in a healthy penis. The P-Long Protocol does not require any synthetic injectables or foreign bodies or extensive penile traction. The P-Long Protocol ultrasound-guided PRP injection can be taught to urologists and sexual medicine practitioners. It does not preclude additional augmentation procedures and is potentially an acceptable first option for men interested in penile enhancement. This study provides a guide for expectations for growth for men using the protocol. The slope of the growth curve indicates possible continued growth with additional treatments. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.

(130) Increasing Penile Length and Girth in Healthy Men Using a Novel Protocol: The P-Long Study

Abstract Introduction Various therapies have been utilized to increase penile length and girth, with some exhibiting significant adverse event profiles, including fillers, fat transfers, suspensory ligament ligation, and silicon augmentation. Our team sought to evaluate a novel combination therapy to enhance penile characteristics using platelet-rich plasma (PRP) as a source of autologous growth factors, penile traction for lengthening, a vacuum erection device for girth enhancement, and nitric oxide precursor supplements to augment penile vascular smooth muscle function. Objective To evaluate the safety and efficacy of combination therapy with PRP, traction, vacuum device, and nitric oxide boosting nutritional supplements to increase penile length, girth, and function in healthy men. Methods A prospective, non-randomized study was designed (NCT04231422) to evaluate the efficacy of combination therapy in healthy men aged 20-55 with baseline normal erectile function and no penile pathology. Penile length and girth measurements were obtained using at-home photography of an erect penis with maximal tumescence. Measurements were obtained at baseline and at monthly intervals x 6 months. PRP (a modified P-Shot ® Procedure) was administered in the right and left corpora under ultrasound guidance once a month for six months using PureSpin double spin system (60cc blood drawn). Centrifuge technical data show an average platelet recovery of 84% and an average concentration of 6.6 times that of the whole blood sample. Using this data, the injection of 10cc of PRP, assuming a starting platelet count of 250K/microliter, would contain approximately 1.65 billion platelets. Subjective erectile function was assessed with a 5 point Likert Scale. RestoreX traction device was utilized for 20 minutes, twice daily, and a Dr Joel Kaplan vacuum erection device was applied with 5-10 mmHg pressure x 12 minutes (1 min x 2, 5 min x 2). Oral nitric oxide boosting supplementation was with AFFIRM, consisting of 3 gm L-Citrulline and 1 gm beet extract. Results A total of 32 men have been enrolled, with 16 having complete data available for review. The 6-month mean increase in the size of the erect penis was 0.85 inches in length (95% CI: 0.75 to 0.94, p-value < 0.01) (range 0.5-1.44) with a linear increase in size. The 6-month mean increase in circumference was 0.47 inches (95% CI: 0.37 to 0.57, p-value <0.01) (range 0.2-0.75). Mean age was 32 and mean baseline erect penile length was 5.70 and girth was 5.25. All 16 participants reported better penile rigidity with erections. No adverse events were reported. Conclusions Results from a pilot study using a novel combination therapy (P-Long Protocol) in healthy men demonstrated increases in penile length, girth, and subjective rigidity improvement compared to baseline with no adverse effects. External validation is warranted. The P-Long Protocol does not require any synthetic injectables or foreign bodies. It does not preclude additional augmentation procedures. The slope of the growth curve indicates possible continued growth with additional treatments. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: BTL Inc.

ПРИМЕНЕНИЕ ГЛУБОКОГО ОБУЧЕНИЯ ДЛЯ АУГМЕНТАЦИИ И ГЕНЕРАЦИИ ПОДВОДНОГО НАБОРА ДАННЫХ С ПРОМЫШЛЕННЫМИ ОБЪЕКТАМИ

The purpose of the study: development of a deep learning method for augmentation and generation of a problem-oriented dataset containing industrial objects, including the development of more efficient data generation and augmentation algorithms based on deep learning, which allow you to create more diverse and realistic data corresponding to industrial objects that can be transferred from one style domain to another. The goal set in the study is related to the actual scientific and technical problem of providing computer vision in systems operating in the underwater environment. These can be autonomous uninhabited underwater vehicles that look for breaks in pipelines, analyze oil leaks, the movement of schools of fish, etc. However, today there is not enough data containing the described objects in the conditions of their real existence. Thus, it is necessary to provide the training sample with realistic images. Research methods: the CycleGAN architecture, which converts a dataset containing images of various objects taken in a laboratory or in a conventional aboveground environment into a dataset containing the cha¬racteristics of an underwater environment. To evaluate the developed augmentation algorithm, it is proposed to use image classification by domains, which can be performed using the ResNet convolutional neural network. Results of the study. A tool is presented to solve the problem of the lack of underwater datasets, a deep learning model is developed, which is used to create images with underwater elements. The model works on the principle of a cyclic generative adversarial network, which receives a real image of an industrial facility in surface conditions as an input, and returns a generated image of the same industrial facility in underwater conditions as an output. Visual analysis of images shows that this method is quite adequate. In addition, a test on the classification model showed almost 100% ability of the neural network to distinguish between domains. Conclusion. The study showed that the CycleGAN model can be used to create images of various objects in the underwater environment. In the future, it is possible to search for additional augmentation procedures, in addition, augmentations of the generated set can be used images, which will also provide researchers and developers with sufficient material with industrial facilities in the underwater environment. This can improve the quality of developments.

Alveolar ridge preservation in extraction sockets of periodontally compromised teeth: A systematic review and meta-analysis.

Alveolar ridge preservation (ARP) procedures can limit bone changes following tooth extraction. However, the role of ARP in periodontally compromised socket lacks strong scientific evidence. The aim of this systematic review and meta-analysis was to evaluate the outcomes of ARP following extraction of periodontally compromised teeth in comparison with extraction alone in terms of hard tissue changes, need for additional augmentation at the time of implant placement, and patient-reported outcomes. Electronic databases were searched to identify randomized controlled trials (RCTs) that compared ARP in periodontally compromised sockets with spontaneous socket healing. The risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Five studies with 134 extraction sockets in 126 participants were included. Of these, ARP was performed in 77 sites, while the remaining sites were intentionally left to heal without any ARP treatment. The follow-up time varied between 6 and 12 months. Overall meta-analysis showed significant differences in changes in ridge height (mean difference (MD) -0.95; 95% confidence interval (CI) -1.43 to -0.47; p=.0001) and bone volume (MD -38.70; 95% CI -52.17 to -25.24; p < .0001) in favor of ARP. The use of ARP following extraction of periodontally compromised tooth was also associated with significantly less need for additional bone grafting at the time of implant placement. Within the limitation of this review, ARP following extraction of periodontally compromised teeth may have short-term positive effects on alveolar ridge height and bone volume and minimize the need for additional augmentation procedures. However, the evidence is of very low to low certainty.

Clinical benefits of ridge preservation for implant placement compared to natural healing in maxillary teeth: A retrospective study.

The purpose of this retrospective study was to determine clinical benefits of ridge preservation in terms of surgical invasiveness of implant placement compared to natural healing in the maxilla. This study included 178 patients with 206 implants placed at ridge-preserved sites and 493 patients with 656 implants placed at naturally healed sites in maxillary anterior and posterior regions. Patient- and implant-related data were collected from electronic dental records including additional augmentation procedures performed before or during implant placement and surgical complications. Cumulative survival rate was assessed using Kaplan-Meier method. The annual peri-implant marginal bone loss between the two groups was compared using the Mann-Whitney U test. The follow-up period was 24.4±18.1months (mean±standard deviation) for ridge-preserved sites and 45.7±29.6months for naturally healed sites. Sinus augmentation was performed at similar frequencies in the two groups, but lateral approach was applied significantly more at naturally healed sites (37.2%) than ridge-preserved sites (8.3%, p≤.001). There was no intergroup difference in the cumulative survival rate or annual peri-implant marginal bone loss. Ridge preservation can be clinically beneficial for minimizing the invasiveness of implant surgery by simplifying the procedure when sinus augmentation is expected in the maxilla.

Assessment of basal implants in compromised ridges.

Aim:The aim of the present study was to evaluate clinically, radiographically, and functionally the outcomes of immediately loaded basal implants when placed in patients with compromised bone/alveolar ridges.Materials and Methods:A total of 18 systemically healthy (9 male and 9 female) subjects with compromised bone with poor quantity or quality were included in the study. A total number of 57 implants was placed, out of which 26 implants were placed in maxilla and 31 implants in mandible. There were 6 patients in which single implants were placed and in rest of the 12 patients, multiple implants were placed, out of which full mouth rehabilitation was done in one patient. In 10 patients, implants were placed immediately in fresh extraction socket and in 7 patients, implants were placed in healed edentulous site. In all the patients, loading was done immediately within 72 h of implant placement. All patients were evaluated for primary and secondary stability, pain, periimplant bone levels using IOPA with grid and CBCT, bleeding, suppuration, sulcular bleeding index, prosthetic complications, and patient satisfaction at specified time intervals.Result:All the values obtained during the study were expressed in the form of mean, standard deviation, and standard error of the mean. The parameters were compared between groups using Paired t-test for intragroup comparison at a similar time, i.e., baseline, 1 month, and 3 months. The data collected was comprehensively analyzed using SPSS software. All implants were successful, with no incidence of infection, nil mobility at the end of the study period of 6 months.Conclusion:Thus, it can be concluded from the present study, that Basal implants can play a vital role in the rehabilitation of patients, where compromised quality and/or quantity of bone is present and additional augmentation procedures would be required for the placement of conventional root form implants.

Complications related to bone augmentation procedures of localized defects in the alveolar ridge. A retrospective clinical study.

This retrospective clinical study aims to evaluate complications after augmentation of localized bone defects of the alveolar ridge. From standardized registrations, the following complications related to bone augmentation procedures were recorded: soft tissue dehiscence, infection, sensory disturbance, additional augmentation procedures needed, and early implant failure. A total of 223 patients (132 women, 91 men; mean age 23.5years; range 17-65years) with 331 bone defects had bone augmentation performed into which 350 implants were placed. Soft tissue dehiscence occurred in 1.7% after GBR procedures, 25.9% after staged horizontal ridge augmentation, and 18.2% after staged vertical ridge augmentation. Infections were diagnosed in 2% after GBR procedures, 12.5% after sinus floor elevation (SFE) (transcrestal technique), 5% after staged SFE, 11% after staged horizontal ridge augmentation, and 9% after staged vertical ridge augmentation. Additional augmentation procedures were needed in 2% after GBR procedures, 37% after staged horizontal ridge augmentation, and 9% after staged vertical ridge augmentation. A total of six early implant failures occurred (1.7%), four after GBR procedures (1.6%), and two (12%) after staged vertical ridge augmentation. Predictable methods exist to augment localized defects in the alveolar ridge, as documented by low complication rates and high early implant survival rates.

The Bone Lamina Technique: A Novel Approach for Lateral Ridge Augmentation—A Case Series

The goal of this case series is to present a novel treatment approach for lateral ridge augmentation. Four systemically healthy patients (aged 48 to 59 years) with inadequate dental alveolar ridge widths were selected for inclusion. All ridge defects were augmented using a xenogeneic cortical bone shield in combination with particulated bone substitutes and a thin collagen barrier. At baseline and after 6 months, digital cone beam computed tomography scans were performed. Biopsy specimens were harvested at reentry surgery and processed for histologic analysis. The results revealed a sufficient amount of bone structure for implant placement without additional augmentation procedures. The histologic analysis demonstrated that new bone formation had taken place and the bone shield had resorbed entirely. This case series indicates that the bone lamina technique has the biologic and mechanical properties to successfully achieve hard tissue augmentation of deficient ridges.

A Randomized Clinical Trial to Evaluate and Compare Implants Placed in Augmented Versus Non‐Augmented Extraction Sockets: 3‐Year Results

The alveolar ridge undergoes reabsorption and atrophy subsequent to tooth removal and thus exhibits a wide range of dimensional changes. Preservation of the alveolar crest after tooth extraction is essential to enhance the surgical site before implant fixture placement. The aim of this randomized clinical study is to investigate and compare the need for additional augmentation procedures at implant insertion, as well as the success rate and marginal bone loss for implants placed in the grafted sites versus those placed in naturally healed sites. Forty patients with ≥1 hopeless tooth were randomly allocated to: 1) a test group, receiving extraction and grafting corticocancellous porcine bone; and 2) a control group, receiving extraction without any graft. After 7 months of healing, implants were inserted in each of the sites. The implants were submerged and loaded after 4 months with metal-ceramic rehabilitation. The follow-up included evaluation of implant diameter and length, the need for additional augmentation procedures at implant placement, implant failure, and marginal bone level changes. All patients were followed over a 3-year period. One implant failed in the control group at the second stage of surgery (6 months after placement); one implant failed in the test group after 2 years of loading. The cumulative implant success rate at the 3-year follow-up visit reached 95% for both groups. No statistically significant differences were detected for marginal bone changes between the two groups. It was concluded that implants placed into grafted extraction sockets exhibited a clinical performance similar to implants placed into non-grafted sites in terms of implant survival and marginal bone loss. However, grafted sites allowed placement of larger implants and required less augmentation procedures at implant placement when compared to naturally healed sites.

Reconstruction of Posterior Mandibular Alveolar Ridge Deficiencies With the Piezoelectric Hinge–Assisted Ridge Split Technique: A Retrospective Observational Report

Reconstruction of alveolar defects in the posterior edentulous mandible can be a difficult task. In addition to complicating anatomic features, such as the inferior alveolar nerve, mental foramen, oblique ridge, and lingual undercut of the mylohyoid ridge, edentulous ridges in the posterior mandible have thicker cortices and decreased volumes of vascular trabecular bone than their maxillary counterparts. Traditionally, these areas have been treated with autogenous block grafts. Significant resorption of these grafts, in combination with patient morbidity at secondary donor sites, has led clinicians to seek alternatives for augmenting the edentulous posterior mandible. The aim of this retrospective consecutive case series is to report on both the technique of the piezoelectric hinge-assisted ridge split procedure for augmenting these sites and the results that were achieved. Thirteen patients with 17 horizontal alveolar ridge deficiencies of the posterior mandible were treated with the piezoelectric hinge-assisted ridge split procedure. After an average healing period of 14 weeks, dental implants were placed into the augmented sites. Intrasurgical alveolar ridge measurements taken at the initial surgery and subsequently at the time of implant placement documented the horizontal gains achieved by this procedure. Overall mean gain in horizontal width was 4.03 mm (± 0.67). For single implant-site augmentations, the mean gain was 3.38 mm (± 0.25). For multiple adjacent implant-site augmentations, mean gain was 4.25 mm (± 0.62). A total of 31 dental implants were successfully placed in all sites and none required additional augmentation procedures. There were no instances of adverse outcomes, such as neurosensory deficits or sequestration of mobilized buccal plates. After a minimum of 6 months of loading, all dental implants have been successful. This retrospective observational report demonstrates that the piezoelectric hinge-assisted ridge split procedure can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. Further prospective and larger observational studies are warranted to see if this is true over a larger patient population and to compare this technique to other more traditionally used approaches.

Unconventional implant treatment: I. Implant placement in contact with ankylosed root fragments. A series of five case reports

Implant treatment presumes that implants are placed in bone, without any contact with root. At ankylosed teeth, complete root removal is often invasive; subsequently, the sites require additional augmentation procedures to complete the treatment. The aim of this paper is to report on a series of five cases that have been treated with an approach that avoided extractive invasive surgery and bone damage. The procedure consisted of preparing the osteotomy site by drilling through the root. At the end of the drilling sequence, the root fragments that were not removed were deliberately left at the osteotomy site. Their mobility was checked with a dental pick and when stable an implant was placed in contact with them. The sites were required to be asymptomatic and inflammation free. Ankylosed teeth were replaced with 13-15-mm-long Osseotite implants, four in the anterior maxilla and one in the anterior mandible. All implants healed uneventfully; they have been now loaded for a period of 12-42 months. On peri-apical radiographs, appearance of the bone-implant interface was similar to osseointegrated implants. The remaining root fragments were visible, in contact with the implants; no specific pathological sign could be detected. A limited resorption of dentine was found at one site after 4 years. This series of cases suggests that implants placed in contact with ankylosed root fragments might not interfere with implant integration or harm occlusal function, at least in the mid-term. More cases are warranted before this procedure might be considered as a reliable clinical option when, at ankylosed teeth, one wishes to avoid an invasive extraction surgery.