Occurrence of Peri-Implant Complications: A Multifactorial Cross-Sectional Study

NCT07638969 | Recruiting DMC

• 1 other identifier: CHUB 003026 OB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peri-Implantitis and Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Peri-implant diseases

  Mucositis of periimplantitis

  12 months

Study Arms (1)

Peri-implant health

Peri-implant mucositis

Device: Dental implant

Interventions

Dental implant DEVICE

Dental implants placed in alveolar bone

Peri-implant health

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients restored with dental implants

You may qualify if:

• Implants placed \>12 months
• TICARE dental implants

You may not qualify if:

• Implants placed \< 12months
• Other implant systems

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead

Study Sites (1)

Cicom Monje

Badajoz, 06001, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Alberto Monje, DDS, MS, PhD

CONTACT

+34924218141; amonjec@umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Alberto Monje Correa

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 6, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)