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Peri-implantitis clinical trials

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NCT ID: NCT06390124 Active, not recruiting - Peri-Implantitis Clinical Trials

Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21)

Start date: September 1, 2022
Phase: Phase 4
Study type: Interventional

Peri-implantitis is considered a bacteria-mediated inflammatory disease that leads to a progressive loss of support. During the last decade, research has been striving to understand this entity and strategies for primary and secondary prevention of the disease; However, all of them are about the effectiveness of different therapeutic modalities for their management. In general, it was stated that surgical therapy was ineffective in resolving inflammation. Therefore, surgical strategies are usually needed to eradicate the pathology. Taking advantage of the knowledge acquired during approximately a period of time about the surgical treatment of periodontitis, if you propose several alternatives. These are mainly based on the morphology of the defect, although other factors, such as the lack of keratinized mucosa or the habit of smoking can alter the decision-making process. As such, peri-implantitis with angular defects (i.e., defects with infraosseous components) is indicated for reconstructive measurements with no barrier membranes. On the other hand, horizontal defects (i.e., defects with supra-crestal components) are more likely to resolve by resecting therapy with or without bone contouring measures. It is interesting to note that, although early data indicated that the morphology of the peri-implantitis defect often shows a well-contained circumferential defect, it has recently been shown that it often presents a 2/3 wall defect configuration, where the buccal plate is commonly missing bone wall. The reason for this characteristic may recur in the dimension of the basal alveolar bones, insufficient critical buccal bone thickness or implant positioning13 in relation to the bone envelope. In addition, it should be noted that ~ 25% of peri-implantitis diagnosed on a daily basis exhibit a combined configuration of defects (i.e., a combination of infraosseous and supra-critical components). For their reconstructive treatment, many biomaterials have been documented, among them several protocols proposed by our research group. However, the use of biological agents or growth factors has not been investigated for a long time. Platelet Derived Growth Factor (PDGF, Platelet Derived Growth Factor) is one of several Growth Factors or proteins that regulate cell growth and Cellular Division. PDGF plays a significant role, especially for Angiogenesis, which implies the growth of blood vessels from the existing vascular tissue. Uncontrolled angiogenesis is characteristic of cancer. Chemically the PDGF is a Glucoprotein chains A (-AA) or B (-BB) or composed of them (-AB). In the field of periodontics, periodontal regeneration has been shown to be successful in obtaining radiographic bone gain and tissue regeneration.

NCT ID: NCT06148012 Active, not recruiting - Peri-Implantitis Clinical Trials

Investigation Of Marginal Bone Loss In Implants With Different Surface Properties And Geometric Designs: A Retrospective Clinical Study

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Purpose: The aim of this study was to investigate the influence of surface characteristics and geometric design on marginal bone loss and bone quality in dental implants. Materials and Methods: A total of 378 implants from 114 patients were evaluated in this study using panoramic and periapical radiographs. Implants were categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations were conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. After obtaining measurements of marginal bone loss and fractal analysis data, the significance of differences between groups was statistically evaluated.

NCT ID: NCT05834946 Active, not recruiting - Periodontitis Clinical Trials

Biological Responses Affecting Early-stage Dental Implant Placement in Patients With History of Periodontitis

Start date: March 4, 2021
Phase: N/A
Study type: Interventional

This prospective parallel, double-blind, four-arm randomised controlled clinical study is planned to assess the difference in the level of the inflammatory biomarkers expressed following the placement of the first dental implant in patients with history of periodontitis (successfully treated) and healthy controls without the disease, during implant osseointegration period. The subjects in both groups will also be randomised to receive one of the two types of implants provided which have different surface treatment.

NCT ID: NCT05765942 Active, not recruiting - Peri-implantitis Clinical Trials

MicroRNAs and Cytokines in Peri-Implantitis Tissue

Start date: June 1, 2022
Phase:
Study type: Observational

Peri-implantitis is a non-linear and accelerating pattern of loss of supporting bone tissue associated with clinical signs of inflammation and increased probing depths compared to baseline measurements. It can present as an asymptomatic condition with infection and fast progression of bone resorption or clinically symptomatic with mucosal inflammation, redness, edema, mucosal enlargement, bleeding on probing (BOP), suppuration, increased probing depth, and radiographic bone loss. The host immune defense against bacterial challenge is responsible for the damage, and the local immune-inflammatory process is associated with disrupted bone remodeling. New studies looking for predictive and accurate early biomarkers for this pathology have the utmost relevance. David Baltimore et al. proposed a feedback loop involving miRNA-146a and TLR signaling, which has been shown to be up-regulated in inflammatory diseases such as osteoarthritis and rheumatoid arthritis. miRNA-146a and miRNA-155 were the first miRNAs identified to be induced in immune cells stimulated by TLRs and proinflammatory cytokines. Precision medicine uses molecular research and different biomarkers, population studies, and big data analysis to recreate complex disease models. Several studies have compared the miRNA profiles of patients with periodontitis with healthy patients. Although periodontitis and peri-implantitis share many features, researchers' findings of periodontitis are not necessarily applicable to peri-implantitis. In fact, based on emerging evidence, peri-implantitis, and periodontitis exhibit several key differences, including their histopathological and molecular characteristics. Considering the aforementioned analysis, inflammatory miRNAs may be differentially expressed in peri-implantitis tissue compared with healthy gingival tissue. This study will investigate the gene expression levels of miRNA-146a and miRNA-155 and their correlation with inflammatory levels of their target genes in human gingival tissue surrounding dental implants diagnosed with peri-implantitis and health.

NCT ID: NCT05615051 Active, not recruiting - Peri-Implantitis Clinical Trials

Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi) - Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes - Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group. The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.

NCT ID: NCT05282667 Active, not recruiting - Clinical trials for Resolution of Pathologic Process

Reconstructive Management of Peri-implantitis

Start date: March 27, 2019
Phase: N/A
Study type: Interventional

With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis. One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy. In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.

NCT ID: NCT05275894 Active, not recruiting - Peri-Implantitis Clinical Trials

Non-surgical Electrolytic Cleaning Peri-implantitis

Start date: October 12, 2022
Phase: N/A
Study type: Interventional

Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.

NCT ID: NCT05171582 Active, not recruiting - Peri-Implantitis Clinical Trials

Peri-implantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The study aimed to assess 6- and 12-months evaluation of clinical, microbiological, and radiography outcomes after performing peri-implantitis regenerative surgical therapy with the bovine bone substitute with or without hyaluronic acid. Materials and Methods: The study could be designed as randomized control clinical trial. Patients with a minimum of one or more early, moderate and advanced stages of the peri-implant lesion will be included in the study. After meeting inclusion criteria, during a regenerative surgical procedure, after mucoperiosteal flap elevation and implant surface decontamination, all patients will be randomly divided into two groups: test group in which bovine bone substitute with hyaluronic acid (HA) (Cerabone plus, Botiss, Germany) will be applied for the filling peri-implant bone defects while in the control group peri-implant bone defects will be filled with bovine bone substitute (Cerabone, Botiss, Germany). Bone grafts will be covered in both groups with collagen dermal matrix (Mucoderm, Botiss, Germany). Clinical, radiograph and microbiological outcomes will be followed at 6 and 12 months after the surgical procedure. ISQ implant stability will be measured before, during a surgical procedure, and 7, 15, 30 days, 3, 6 and 12 months after a surgical procedure.

NCT ID: NCT04421066 Active, not recruiting - Peri-Implantitis Clinical Trials

Histological, Genetic and Epigenetic Analysis of Procedures Related With Dental Implants

Start date: January 29, 2019
Phase:
Study type: Observational [Patient Registry]

In this study genomic, proteomic and histological technologies for the search and characterization of epigenetic modifications and molecular or protein markers, useful in the diagnosis and progression of peri-implant diseases and prevention of implant failure will be used.

NCT ID: NCT04369170 Active, not recruiting - Periimplantitis Clinical Trials

Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments

Start date: April 25, 2019
Phase: N/A
Study type: Interventional

Study Title: Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants, or with intermediate abutments. A Randomized Clinical Trial. - Objectives: To evaluate differences on changes on the interproximal marginal bone level 12 months after the connection of CAD/CAM designed prosthesis with an intermediate abutment (3mm long) or directly placed to bonelevel implants. Secondary objectives will be evaluate changes on the soft tissues and implant survival, as well as patients' satisfaction 3, 6 and 12 months after the connection of the definitive prosthesis. - Design and Outcomes: Randomized double-blinded clinical trial with parallel design to asses the effect of CADCAM designed bridges directly placed - Interventions and Duration: Patients will be selected according to the inclusion/exclusion criteria among those who attend the Unit of Periodontology of the University of Santiago de Compostela. After clinical and radiological implant planning, implant surgical placement will be scheduled. 2 MOZO GRAU® INHEX ST implants, with 3.75 mm or 4.25 mm of diameter and 8mm, 10mm or 11.5mm length will be placed on each patient, according to the bone availability. After 8 weeks of submerged healing, second stage surgery will be performed and definitive impression will be taken. All groups patients will keep a heeling abutment until the definitive prosthesis is placed, 3 weeks later (test group: direct to implant / control group: abutment 3 mm long). Clinical and radiological assessment after 1, 3, 6 and 12 months will be performed. Each participant will be on study about 15 months since the recruitment visit until the end of the study. - Sample Size and Population: Based on previous studies, a sample size calculation determined that a group of 32 subjects, considering possible dropouts, will provide 80% power to detect a true radiographic difference of 0.80mm between groups after 12 months of observation since the definitive prosthesis connection. (Blanco et al 2017, Nóvoa et al 2017). A common standard deviation between groups was calculated (SD=0.715268015). A p ≤ 0.05 value will be considered significant (JM. Domenech & R. Granero 2010). A balanced random permuted block will be applied to prepare the randomization tables, stratifying for smoking habits (yes/no) with a 1:1 ratio between test and control groups.