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Tundra lists 16 Implant Complication clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07456163
Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations
Objectives: To compare the influence of pre-fabricated titanium abutments and customized milled zirconia abutments on implant biocompatibility and the peri-implant region, as well as on radiographic bone loss and oral health-related quality of life. Detailed Methodology: This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations. The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period. After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power. The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols. Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis, comprehensive periodontal clinical parameters, measurement of keratinized mucosa thickness, standardized periapical radiographs for marginal bone level assessment, and intraoral digital scanning for volumetric and soft tissue analysis. The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period. This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.
Gender: All
Ages: 18 Years - 70 Years
Updated: 2026-03-17
1 state
NCT04731025
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-02-12
NCT05361980
Pediatric Orthopaedic Implant Safety & Efficacy
Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity. Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy. Prospective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).
Gender: All
Ages: 0 Years - 25 Years
Updated: 2025-11-24
1 state
NCT05729607
Vertical Soft Tissue Augmentation With CTG vs ADM
The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative
Gender: All
Ages: 18 Years - 99 Years
Updated: 2025-09-18
1 state
NCT06649890
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections (SSIs) following implant-based breast reconstruction in female patients, aged 18 and older. It will also assess the safety and overall surgical outcomes when using Xperience™ compared to povidone-iodine. Main Questions the Study Aims to Answer: * Does the use of Xperience™ decrease the incidence of surgical site infections compared to povidone-iodine? * What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience™ and those treated with povidone-iodine? * Are there fewer post-surgical complications with Xperience™ compared to povidone-iodine? Study Design: Participants in this study will be randomly assigned to receive either Xperience™ or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction. Only the research team will know which irrgiation is given- the participant will not know. Participant Will: * Undergo the surgical procedure using one of the two irrigation solutions. * Receive regular post-operative check-ups to monitor for signs of infection and other complications. * Have data collected on any post-surgical complications, the necessity for early implant removal, and overall surgical outcomes.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2025-08-07
1 state
NCT05576922
Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences
The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB
Gender: All
Ages: 18 Years - Any
Updated: 2025-04-10
1 state
NCT06917638
Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol
The goal of this \[type of study: clinical trial\] is to \[investigate the influence of Oversized Drilling Versus Traditional for implant Stability and Crestal Bone Loss.\] in \[ Healthy Patient aged between 20 and 60 years with one missing tooth in the posterior mandible with sufficient bone dimensions\]. The main question\[s\] it aims to answer are: the influence of oversized drilling versus traditional drilling in the mandibular arch, in terms of implant stability and crestal bone levels. The effects of oversized protocol have not been fully explored on the more compact mandibular bone. Participants will Control Group: Under-sized drilling group (UD): Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant. * Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet. * After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading. * The smart peg will then be removed and will be replaced with a healing collar above the gingival margin. * The flap will then be sutured back to its original position around the healing collar with an interrupted suture. * A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
Gender: All
Ages: 20 Years - 60 Years
Updated: 2025-04-08
NCT06355713
Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant. The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena. Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations.
Gender: FEMALE
Ages: 35 Years - 75 Years
Updated: 2025-03-07
NCT06038487
Immediate Versus Delayed Loading of Maxillary Overdenture Implants
The purpose of the study is to evaluate the radiographic, clinical and patient-centered outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to delayed loading approach by primarily evaluating radiographic bone loss of dental implants placed in the maxilla over 36 months
Gender: All
Ages: 21 Years - Any
Updated: 2025-02-28
1 state
NCT06554080
Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces.
This is a retrospective cohort study that evaluates the survival (Outcome 1) of dental implant systems (external connection (Cohort 1) and internal connection (Cohort 2) and the effectiveness of maintaining crestal bone levels (Outcome 2), placed within United Kingdom Armed Forces personnel. The secondary objectives include: assessment of block bone grafting on outcome, assessment of restoration (bridge vs crown on outcome) and assessment of placement technique (immediate, early, delayed placement). Inclusion criteria: all military patients that received dental implants since 2014-2024. Exclusion criteria: military patients that have not received radiographic review or follow-up of the dental implant or who have left service or have a follow-up that is less than 12-months post placement of the dental implant..
Gender: All
Ages: 18 Years - Any
Updated: 2024-08-14
1 state
NCT06515886
Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both.
Gender: All
Ages: 18 Years - Any
Updated: 2024-07-23
1 state
NCT06506695
Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded. This study aims to achieve two goals: 1. To load the implants with a nose or ear prosthesis within one month (preferably \<3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated. 2. Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.
Gender: All
Ages: 18 Years - Any
Updated: 2024-07-17
NCT06477874
Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.
The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability. In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants. This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss
Gender: All
Ages: 18 Years - 55 Years
Updated: 2024-06-27
NCT06447792
Survival Rate of 2 Implant-supported Short-span Fixed Partial Dentures
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability.1 Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.
Gender: All
Ages: 25 Years - 65 Years
Updated: 2024-06-07
NCT06363903
ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation
In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics.
Gender: All
Ages: 18 Years - Any
Updated: 2024-04-12
3 states
NCT06307691
Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol
For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat. Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion. The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability.
Gender: All
Ages: 20 Years - 60 Years
Updated: 2024-03-19