NCT07530211

Brief Summary

This cross-sectional study evaluates the impact of systemic risk factors, including diabetes mellitus, smoking, cardiovascular disease, and osteoporosis, on peri-implant health status and clinical indices. The study included 93 patients with a total of 314 implants that have been in function for at least three years. The primary goal is to determine how these systemic conditions influence the prevalence of peri-implant mucositis and peri-implantitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

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

March 11, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

9 days

First QC Date

March 23, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

Diabetes MellitusSmokingCardiovascular DiseaseOsteoporosisPeri-implant Health

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Peri-implant Diseases

    Distribution of dental implants categorized into three status groups: healthy, peri-implant mucositis, and peri-implantitis based on clinical and radiographic criteria

    Minimum 3 years post-loading veya At clinical assessment, at least 3 years after implant loading

Secondary Outcomes (3)

  • Gingival Index (GI)

    At least 3 years after implant loading

  • Plaque Index (PI)

    At least 3 years after implant loading.

  • Probing Depth (PD)

    At least 3 years after implant loading.

Study Arms (5)

Smoking Group

Patients who are current smokers or use tobacco products

Other: Clinical and Radiographic Periodontal Assessment

Diabetes Mellitus Group

Patients diagnosed with diabetes mellitus

Other: Clinical and Radiographic Periodontal Assessment

Cardiovascular Disease Group

Patients with a history of cardiovascular diseases

Other: Clinical and Radiographic Periodontal Assessment

Osteoporosis Group

Patients diagnosed with osteoporosis

Other: Clinical and Radiographic Periodontal Assessment

Systemically Healthy Group

Individuals with no systemic diseases and no history of smoking

Other: Clinical and Radiographic Periodontal Assessment

Interventions

Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status

Cardiovascular Disease GroupDiabetes Mellitus GroupOsteoporosis GroupSmoking GroupSystemically Healthy Group

Eligibility Criteria

Age27 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients who visited the Department of Periodontology at Inonu University Faculty of Dentistry. The sample includes systemically healthy individuals and patients diagnosed with diabetes mellitus, cardiovascular disease, or osteoporosis, as well as current smokers.

You may qualify if:

  • Patients with at least one dental implant in function for at least three years.
  • Patients aged between 27 and 72 years.
  • Availability of complete clinical and radiographic records.

You may not qualify if:

  • Implants in function for less than 3 years.
  • Pregnancy or lactation.
  • History of radiation therapy in the head and neck region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Dentistry

Battalgazi, Malatya, 44300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-ImplantitisDiabetes MellitusSmokingCardiovascular DiseasesOsteoporosis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 15, 2026

Study Start

March 11, 2026

Primary Completion

March 20, 2026

Study Completion

March 23, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The de-identified individual participant data (IPD) that support the findings of this study are available from the corresponding author upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available beginning 6 months and ending 36 months following publication
Access Criteria
Requests for data should be directed to the corresponding author via email. To gain access, data requestors will need to provide a methodologically sound proposal

Locations