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.
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
- Conditions the study is for
- Peri-Implantitis and Peri-implant Mucositis
- 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.
Spain1 site, 1 recruiting
- Recruiting
Cicom Monje
Badajoz, 06001
Jorge OSORIO, DDS, +34924205117, amonjec@umich.edu
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 group | Role | What they receive |
|---|---|---|
| Peri-implant health | Peri-implant mucositis Receives: Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Jun 2026
- Study start6 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implantitis and Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Peri-Implant Complications: A Multifactorial Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07638969
- Acronym / sponsor ID
- CHUB 003026 OB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 6 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peri-implant health | – | Device: Dental implantPeri-implant mucositis |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients restored with dental implants
Key inclusion criteria (2 listed)
- Implants placed >12 months
- TICARE dental implants
Key exclusion criteria (2 listed)
- Implants placed < 12months
- Other implant systems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implantDental implants placed in alveolar bone | Device | Peri-implant health |
Primary outcome
Peri-implant diseases
Time frame: 12 months
Mucositis of periimplantitis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.