NCT07633912

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 4, 2024

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Peri-implantitis

    Bone loss (≥3mm) occurring with clinical signs of inflammation

    >12 months

Interventions

Impact of implant-related local factors on the onset/progression of peri-implantitis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Partially edentulous patients with dental implants exhibiting peri-implantitis

You may qualify if:

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

You may not qualify if:

  • Complete edentulous patients
  • Inconsistent definition of peri-implantitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, 06011, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Alberto Monje Correa, DDS, MS, PhD

    CICOM MONJE

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

June 8, 2026

Study Start

August 10, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

June 8, 2026

Record last verified: 2024-12

Locations