- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07638969
Occurrence of Peri-Implant Complications: A Multifactorial Cross-Sectional Study
Dental implants have become, over recent decades, one of the most effective and predictable therapeutic options for replacing missing teeth. Due to their high survival rates and their ability to restore both function and aesthetics, implants are now a fundamental component of modern restorative dentistry. However, despite their widely documented success, implant-supported rehabilitations are not exempt from complications, especially biological ones, which may compromise long-term prognosis. Understanding these events and the factors that influence them represents a significant clinical and scientific need.
Among the most frequent biological complications are peri-implant mucositis and peri-implantitis, inflammatory conditions that affect the soft and hard tissues surrounding the implant. Their onset is closely related to the formation and accumulation of bacterial biofilm on the prosthetic and implant surfaces, triggering an inflammatory response that, in advanced cases, can lead to progressive marginal bone loss. The literature suggests that the prevalence of these pathologies has increased as implant treatments have become more common, reinforcing the importance of evaluating the biological behavior of implants in various clinical contexts.
In this regard, microbiological assessment is a cornerstone for understanding the etiology and progression of peri-implant complications. The structural characteristics of biofilm around implants differ partially from those observed around natural teeth, which may influence the virulence of the microorganisms involved and their ability to induce inflammation. Moreover, patient-related factors-such as systemic health status, habits like smoking, or oral biofilm control-as well as implant-related variables-such as surface characteristics, macro-geometry, and prosthetic design-can modify microbial composition and tissue response. Therefore, microbiological evaluation not only identifies predominant pathogens but also provides essential information for developing individualized preventive and therapeutic strategies.
Alongside biological and microbiological assessment, radiographic evaluation has become an indispensable method for assessing bone stability around dental implants. Conventional and digital radiographic techniques allow clinicians to objectively monitor marginal bone loss, considered one of the most important parameters for determining the long-term success or failure of implants. Correlating radiographic findings with clinical indicators of inflammation provides a comprehensive understanding of implant health and enables early detection of potential complications. Additionally, radiographic interpretation helps identify surgical and prosthetic factors associated with bone remodeling, such as the three-dimensional position of the implant, crown-to-implant ratio, abutment design, or the patient's bone quality.
Despite the extensive knowledge available on implant therapy, uncertainties remain regarding the interplay between biological, microbiological, and radiographic factors in the development and progression of peri-implant complications. Evidence suggests that these elements do not act independently but rather form an integrated system where biofilm, immune response, and bone stability influence one another. For this reason, research that combines these three dimensions is essential to achieving a more complete understanding of implant behavior in real clinical scenarios.
The present research project aims to evaluate the behavior of dental implants in relation to biological complications, microbiological findings, and radiographic outcomes, with the goal of identifying patterns, associations, and potential risk factors that may affect treatment success. This multidimensional approach will allow the analysis not only of inflammation or bone loss but also of the microbial composition associated with these conditions and its relationship with clinical and radiographic findings. By integrating these components, the study seeks to generate evidence that contributes to improving diagnostic, maintenance, and treatment protocols for patients rehabilitated with dental implants.
The importance of this investigation lies in the need to optimize the long-term predictability of implant-supported treatments. Early detection of complications, identification of key microorganisms involved in peri-implant diseases, and precise evaluation of bone stability are essential tools for ensuring successful outcomes. Furthermore, the results of this study may support patient education regarding biofilm control and enhance clinical strategies aimed at preventing peri-implant pathology.
Taken together, the simultaneous analysis of biological, microbiological, and radiographic aspects will provide a comprehensive perspective on peri-implant conditions and a deeper understanding of the factors that determine the performance of dental implants. Ultimately, the study intends to genera
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alberto Monje, DDS, MS, PhD
- Phone Number: +34924218141
- Email: amonjec@umich.edu
Study Locations
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-
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Badajoz, Spain, 06001
- Recruiting
- Cicom Monje
-
Contact:
- Jorge OSORIO, DDS
- Phone Number: +34924205117
- Email: amonjec@umich.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Implants placed >12 months
- TICARE dental implants
Exclusion Criteria:
- Implants placed < 12months
- Other implant systems
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Peri-implant health
Peri-implant mucositis
|
Dental implants placed in alveolar bone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peri-implant diseases
Time Frame: 12 months
|
Mucositis of periimplantitis
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB 003026 OB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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