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

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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

      • 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

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

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.

Investigators

  • 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)

August 10, 2024

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

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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