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NCT06305000
This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is: Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone? Our study consists of 4 groups: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples. Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.
NCT07393828
This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis. Peri-implant mucositis is a reversible inflammatory condition of the peri-implant soft tissues caused primarily by bacterial biofilm accumulation. Effective plaque control is essential for the prevention of disease progression to peri-implantitis. However, there is limited clinical evidence regarding the comparative effectiveness of different interproximal oral hygiene devices in implant-supported sites. A total of approximately 75 patients with posterior single implants and peri-implant mucositis will be recruited. Participants will be randomly allocated to one of the study groups, each using a specific interproximal oral hygiene device as part of their daily oral hygiene regimen. All participants will receive standardized oral hygiene instructions at baseline. Clinical parameters related to peri-implant inflammation and plaque accumulation will be assessed at baseline and at follow-up visits at 1, 3, and 6 months. The primary outcome is the reduction of peri-implant biofilm accumulation. Secondary outcomes include changes in clinical inflammatory parameters around the implants. The results of this study are expected to provide clinically relevant evidence to support evidence-based recommendations for interproximal oral hygiene in patients with dental implants affected by peri-implant mucositis.
NCT07349095
1. Background and Rationale The visual diagnosis of peri-implant mucosal erythema (redness), a key sign of inflammation, is highly subjective and varies significantly among clinicians, leading to inconsistencies in early detection and monitoring of peri-implant diseases. There is a critical need for an objective, quantitative, and reliable tool to standardize this assessment. Recent advances in artificial intelligence (AI) and colorimetric analysis of digital intraoral scans offer a promising solution to this clinical challenge. 2. Primary Objectives This diagnostic study aims to: Develop and validate a core colorimetric index that objectively quantifies mucosal erythema from digital intraoral scan data. Develop and validate an AI model that automatically calculates this index and provides a binary diagnosis (erythema present/absent) at the image level. Develop and validate a second AI model for precise localization (object detection) of erythematous regions on standard clinical software screenshots. Evaluate the clinical utility of the AI system by assessing its impact on the diagnostic accuracy, consistency, and confidence of clinicians with varying experience levels. 3. Study Design This is a multiphase diagnostic accuracy study conducted at a single academic center. It comprises three sequential phases with independent validation: Phase 1 (Development \& Internal Validation): Analysis of intraoral scans to derive the color index and train the AI models using an internal dataset. Phase 2 (External Technical Validation): Prospective validation of the trained AI models on an independent cohort of patients from a separate branch of the hospital. Phase 3 (Clinical Utility Assessment): A prospective, controlled, observer study where clinicians perform diagnoses with and without AI assistance. 4. Participants and Methods Data Source: Adult patients with dental implants who received intraoral scans using a 3Shape TRIOS 3 scanner. Image Data: Two formats are used: 1) Processed 3D surface files (PLY format) for colorimetric analysis, and 2) Standardized 2D screenshots from the 3Shape software for object detection. Reference Standards: Expert consensus on erythema (primary) and Bleeding on Probing (BOP, clinical inflammatory standard). AI Development: Deep learning models (e.g., convolutional neural networks) will be trained for index calculation, image-level diagnosis, and region localization. Observer Study: Participating clinicians (experts, general dentists, and students) will diagnose a set of test images both unaided and with AI assistance (which displays the color index value and/or bounding boxes). 5. Key Outcome Measures Diagnostic Accuracy: Area under the receiver operating characteristic curve (AUC), sensitivity, specificity (with 95% confidence intervals). Technical Performance: Intraclass correlation coefficient (ICC) for automated measurement agreement; Mean Average Precision (mAP) and Dice Similarity Coefficient for object detection. Clinical Impact: Change in diagnostic accuracy (AUC), inter-observer agreement (Kappa), and diagnostic confidence scores when using AI assistance. 6. Significance This study seeks to translate a subjective clinical sign into an objective, AI-powered diagnostic biomarker. If successful, the proposed system could become a valuable decision-support tool in daily practice and clinical research, promoting earlier, more consistent, and standardized monitoring of peri-implant tissue health, ultimately improving patient care.
NCT07304752
Evaluate whether the type of probe (plastic vs. metallic) modifies the accuracy of peri-implant probing in single-unit implants, by comparing the probing depth recorded with the prosthesis in place versus without the prosthesis (ΔPD, mm). Secondarily, explore the influence of prosthetic design and implant position on probing values and on other clinical and radiographic parameters.
NCT07300657
Background: Dental implant therapy is a well-established and predictable procedure for replacing missing teeth, with high long-term survival rates. However, poor oral hygiene remains one of the main modifiable risk factors for peri-implant diseases such as mucositis and peri-implantitis. Objective: The aim of this randomized controlled clinical trial is to evaluate the effectiveness of an artificial intelligence (AI)-based chatbot, developed and validated by dental experts, in improving oral hygiene and clinical outcomes in patients with implant-supported restorations, compared to traditional educational methods such as printed leaflets and dental hygienist sessions. Methods: A total of 110 adult patients rehabilitated with dental implants were randomly assigned to either an AI chatbot intervention group or a control group receiving standard oral hygiene education. The chatbot provides continuous, personalized education and motivation through natural language interaction. Clinical and radiographic parameters, including plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and marginal bone loss (MBL), were recorded at baseline and at follow-up visits. Expected outcomes: It is hypothesized that the use of an AI-based chatbot will significantly improve oral hygiene compliance and clinical outcomes compared to conventional methods. Significance: The study aims to demonstrate the potential of AI-assisted patient education in promoting long-term peri-implant health and preventing peri-implant diseases.
NCT07295743
The study was conducted at the Division of Periodontology, Bolu Abant İzzet Baysal University Faculty of Dentistry. Participants were systemically healthy individuals aged 18 to 70 who had received dental implant prostheses within the past five years and had high-quality panoramic radiographs. The peri-implant status of the subjects was evaluated using various indices and radiographic analyses in accordance with Chicago's Classification of Periodontal and Peri-Implant Diseases and Conditions. Additionally, measurements of gingival thickness, gingival phenotype, keratinized gingival width, and emergence angle were performed.
NCT07104760
Peri-implantitis is a pathological condition characterized by the inflammation of peri-implant connective tissues and progressive alveolar bone loss. There is a global concern about the increasing prevalence of this disease, which may affect up to 43% of implants in function. This cohort study will evaluated the long term follow up of a randomized, controlled, double-blind placebo study that evaluated the regenerative treatment of peri-implant diseases with surgical debridement and Er,Cr:YSGG AG laser associated with systemic antibiotics. A total of 80 subjects with peri-implantitis (PD\>5mm, BoP and/or sup, bone loss \>3mm) will be treated reavluated after 10years follow-up. Clinical, radiographic, and microbiological parameters will be recorded at baseline and 120 months follow-up. The primary outcome variable of this trial was be the difference between groups for the change in clinical attachment level from baseline to 6 months. We did consider composite outcomes, although not as the primary outcome. We also aim to evaluate the number and percentage of patients (and implants) reaching the following clinical endpoint for treatment: Probing depth \< 5mm, absence of bleeding on probing and no further bone loss (Heitz-Mayfield and Mombelli, 2014). The secondary variables will be the differences between groups in PI, GI, BOP, SUP and PD and microbial profile.
NCT06923748
This randomized clinical trial aims to compare the efficacy of two interproximal cleaning devices-superfloss and interdental brushes- in patients diagnosed with peri-implant diseases. The study evaluates plaque control and bleeding scores. Patients will be randomly assigned to one of two oral hygiene protocols and will be monitored through clinical examinations and validated questionnaires assessing both clinical and radiographic parameters and patient-reported outcomes.
NCT06383351
Despite extensive research on periodontitis, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. The study aims to assess patient perception of these diseases and their impact on quality of life through a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics at "Le Scotte" University Hospital and will undergo diagnosis followed by questionnaire assessments. No follow-up visits are planned, and validated questionnaires will be administered to evaluate perception and impact on quality of life. Study procedures will include recording biometric peri-implant parameters and administering questionnaires such as the Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14).
NCT06137846
The investigators are evaluating the therapeutic outcomes of two cleaning instruments on treating peri-implant mucositis. Peri-implant mucositis is inflammation around an implant that is limited to only the gum tissue and is characterized by bleeding on probing, pus, and without any evidence of bone loss. The investigators wish to compare the amount of inflammation and bacteria through measurements (like probing depth) and by collecting fluid and plaque samples around participants' implant after using one of the two cleaning instruments.
NCT07047261
The peri-implant mucositis is an inflammatory and reversible lesion that surrounds the peri-implant mucosa without loss of supporting bone, clinically characterized by bleeding on gentle probing. It has been estimated that it affects approximately 21% to 88% of individuals and 9% to 51% of implant sites, with prevalences of 47% and 29%, respectively. Experimental clinical researches show that peri-implant mucositis can be reversed if proper biofilm management is maintained. Prevention and regression of inflammation around the implant can be achieved through proper oral hygiene and an effective supportive care protocol, which may include regular clinical check-ups, radiographic assessments, oral hygiene instructions and professional mechanical plaque removal (PMPR). Therefore, adjunctive measures such as self-administration of oral rinse antiseptics (i.e. chlorhexidine) may be considered. For examples, the use of a chlorhexidine-based gel in combination with xanthan (XanCHX), in addition to PMPR has demonstrated clinical improvements in the treatment of periodontitis. The aim of the present study was to investigate the potential benefits of XanCHX gel in adjunction to PMPR in patients affected by peri-implant mucositis, promoting a complete healing of the affected tissues.
NCT06392256
The goal of this randomized clinical study is to investigate the impact of soft tissue phenotype modification following free gingival grafting (FGG) in addition to the non-surgical mechanical therapy of peri-implant mucositis (PM) with keratinized mucosa width (KMW) \< 2 mm over a 6-month follow-up period. Therefore, the following questions related to the study are raised: • Does soft tissue modification following free gingival grafting around the implants with KMW \< 2 mm, in addition to non-surgical mechanical therapy of PM, affect the change in bleeding on probing and the rate of complete disease resolution? Patients who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University, are systemically healthy, have implant-supported restorations installed at least one year prior to their enrollment, and are diagnosed with PM on these implants will be selected for the study. Patients with KMW \< 2 mm at the respective implant sites will be treated with non-surgical mechanical treatment combined with soft tissue augmentation with FGG or non-surgical mechanical treatment alone.
NCT06915623
This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods. The central research question is: Does the gel reduce gum bleeding? Researchers will compare the effects of traditional dental cleaning alone wit those of dental cleaning combined with gel administration, focusing on overall gum health around implants. The study will enroll eight participants-some with early gum issues, such as bleeding gums, and others with healthy gums. Each participant will be randomly assigned to receive either regular dental cleaning or the cleaning paired with gel application. The study process includes the following steps: 1. Participants will visit the clinic and receive one of the two treatments randomly. 2. One week later, they will complete a printed survey detailing any symptoms or discomfort experienced . 3. After four weeks, participants will return to the clinic for checkups and tests to measure progress.
NCT06867250
This research aims to explore the influence of vitamin D on the body's defense system by examining its impact on specific proteins involved in immune response and inflammation in the soft tissues surrounding dental implants. Also aims to determine how vitamin D levels affect these proteins and their role in protecting peri-implant tissues from microbial infections and inflammation.
NCT06863116
Peri-implant diseases, such as peri-implant mucositis and peri-implantitis, are inflammatory conditions that affect the tissues surrounding dental implants. If untreated, these diseases can lead to bone loss and implant failure. This study investigates whether low oxygen levels (hypoxia) in the peri-implant environment influence ferroptosis, a type of cell death associated with oxidative stress. The research focuses on three key biomarkers: hypoxia-inducible factor-1 alpha (HIF-1α), glutathione peroxidase-4 (GPX-4), and malondialdehyde (MDA). A total of 45 participants with 62 dental implants were included in the study. They were divided into three groups: peri-implant health, peri-implant mucositis, and peri-implantitis. Peri-implant crevicular fluid (PICF) samples were collected, and the levels of HIF-1α, GPX-4, and MDA were measured using laboratory tests. The study aims to determine whether hypoxia affects ferroptosis-related pathways by altering GPX-4 and MDA levels. Understanding these mechanisms could provide new insights into peri-implant disease progression and help develop improved treatment strategies.
NCT06761521
68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients. The condition of the attachment tissues of these implants is monitored at a control visit after five years.
NCT06288919
The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts. A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups: * Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS) * Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used. Different subgroups will be defined according to the material of the dental crown of the related implant. The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index.
NCT06740123
To date, systemic/local antibiotics, antimicrobials, laser application, and probiotics have been used as adjuncts to improve the outcome of non-surgical periodontal treatment for both periodontitis and peri-implantitis patients. H42® hydrogel, obtained by combining a high molecular weight hydrogel with type I collagen, is a collagen paste for regenerating periodontal/peri-implant pockets caused by periodontitis/peri-implantitis. This study aimed to clinically, biochemically, and radiologically evaluate the effect and reliability of hydrogel application into the pocket in addition to non-surgical periodontal treatment in the treatment of periodontal and peri-implant pockets. Fifteen patients with stage 2 periodontitis, each with 30 teeth and 30 implants with 5-8 mm pocket depth in the contralateral quadrants, and a total of 30 patients, will be equally divided into two groups. The test group will receive non-surgical periodontal treatment followed by H42 hydrogel application (Hydrogel Oral- 3 syr 0.4 cc/syr), while the control group will receive only non-surgical periodontal treatment. All patients will undergo the same procedure of non-surgical periodontal treatment
NCT05356806
the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.
NCT04052373
This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis. Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.