Local Factors in the Onset/Progression of Peri-implantitis: A Retrospective Study

June 5, 2026 updated by: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

With the increasing burden of peri-implantitis worldwide, interest in the management of this pathology has flourished. However, there is a lack of consensus in the search for a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable results. Among these, evidence supported the application of resective, reconstructive or combined approaches to limit progressive bone loss and achieve soft tissue health. However, to date, the most appropriate modality is unknown and the decision-making process derives from the understanding gained in the management of periodontitis.

A very relevant aspect of peri-implantitis is that the prevalence tends to be higher at the patient level than at the implant level. This indicates that it is a pathology in which there are localized factors that may contribute to the onset and/or perpetuation of the pathology. Some of the factors that have been demonstrated in the literature point to the characteristics of the peri-implant soft tissues, as well as the position of the dental implants. However, the role of each local factor in the predisposition or protection of peri-implant disease or health is still largely unknown. The objective of this study is therefore to evaluate, in partially edentulous patients with multiple implants, the localized factors associated with peri-implantitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Variables to explore:

Patient-related variables:

  • Periodontal health (health, pathology)
  • Periodontal status classification (stage, grade)
  • Smoker (S, NS, FS)
  • Compliance (NC, C, CE)
  • Age (y)
  • Time since implants (y)
  • Pathology (DM, CVD, OP, other)
  • Medication
  • Anticoagulant (y/n)
  • Plaque control (<20%, >20%, >50%)

Clinical variables:

  • Keratinized mucosa (narrow, wide, lack)
  • Vestibule (Deep ≥4mm, shallow <4mm, lack)
  • Number of implants supporting the prosthesis (n)
  • Implant location in the fixed prosthesis (mesial, distal, medial)
  • Interproximal access with a 0.5mm brush between implants (IP-i)
  • Interproximal access with a 0.5mm brush between implants implant-tooth (IP-t)
  • Prosthesis type (SC, FPD)
  • Cemented or screw-retained (C, S)
  • Ceramic to connection (Y/N)
  • Prosthesis material (Zr, Cr-Co)
  • Implant (NB, ST, TC, DT, BTI, other)
  • Implant diameter (mm)
  • Implant length (mm)
  • Position (M, PM, A, a, pm, m)

Radiographic variables:

  • Distance between implants (m-d)
  • Distance to adjacent tooth (m-d)
  • Occlusal deviation towards buccal-lingual (b-l)
  • Apico-coronal position with respect to adjacent tooth (a-c) with respect to LAC
  • Apico-coronal position with respect to adjacent implant (a-c) with respect to coronal
  • Inclination (implant deviation º) (m-d), (b-l) and º
  • Defect configuration (Monje et al. 2019)
  • Implant type (BL, TL)
  • Transmucosal abutment (Y, N, short <2mm, long ≥2mm)
  • Inadequate implant-prosthesis connection (Ill-fitting)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06011
        • Centro de Implantologia Cirugia Oral y Maxilofacial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Partially edentulous patients with dental implants exhibiting peri-implantitis

Description

Inclusion Criteria:

  • Partially edentulous patients
  • Peri-implantitis and non-peri-implantitis implants
  • Readable x-ray and clinical signs of inflammation/health

Exclusion Criteria:

  • Complete edentulous patients
  • Inconsistent definition of peri-implantitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peri-implantitis
Time Frame: >12 months
Bone loss (≥3mm) occurring with clinical signs of inflammation
>12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Alberto Monje Correa, DDS, MS, PhD, Cicom Monje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18002909(B)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Publication in a journal in dentistry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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