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Peri-Implantitis and Peri-implant MucositisNCT07638969

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

An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 90 yearsHealthy volunteers can take part
What is being tested?
Dental implant
Type of treatment
Medical device
How many people
150 participants
Where
1 siteSpain
Study dates
6 Jun 2026to 1 Jul 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Patients restored with dental implants

Who may be able to join

  • Implants placed >12 months
  • TICARE dental implants

Who cannot join

  • Implants placed < 12months
  • Other implant systems

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alberto Monje, DDS, MS, PhD contact

+34924218141

amonjec@umich.edu

Spain1 site, 1 recruiting
  • Cicom Monje

    Badajoz, 06001

    Jorge OSORIO, DDS, +34924205117, amonjec@umich.edu

    Recruiting

Other trials in Spain

About this 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.

Read more

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

Being tested
Dental implant
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental implantDevice

    Dental implants placed in alveolar bone

Study groups in NCT07638969
Study groupRoleWhat they receive
Peri-implant healthPeri-implant mucositis
Receives: Device: Dental implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peri-implant diseases

    Mucositis of periimplantitis

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start6 Jun 2026
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638969
Sponsor's protocol ID
CHUB 003026 OB
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alberto Monje, DDS, MS, PhD (+34924218141, amonjec@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-implant diseases (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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