NCT05897736

Brief Summary

Patients included in the study will be recruited after arriving at the Faculty of Dentistry of the University of Zagreb. During the clinical examination, the patient's periodontal status (bleeding during probing, and the depth of the pockets around the implant) and a control x-ray will be taken to check bone loss. Saliva sampling will occur at 3-time points, when establishing the diagnosis of periimplantitis, before the start of therapy, and at the first control after treatment.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Oct 2023

Typical duration for all trials

Status
not yet recruiting

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 Progress89%
Oct 2023Sep 2026

First Submitted

Initial submission to the registry

June 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

June 1, 2023

Last Update Submit

June 1, 2023

Conditions

Keywords

salivary mineralsperi-implantitisperi-implant healthsalivary biomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in levels of salivary minerals with disease progression/regression

    If it is shown that the minerals of bone metabolism change according to the direction of recovery, it is possible to use salivary minerals (calcium, magnesium and phosphates) as an aid in the prognosis of the course of recovery and reduce the time needed to make a decision on the type and intensity of therapy, as well as the loss itself and implant replacement

    one year

Study Arms (1)

peri-implant patient

Patients with diagnosed peri-implantitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

•Patients who come for examination and treatment of the inflammatory process of a dental implant, peri-implantitis at School of dental medicine University in Zagreb. In order to confirm the diagnosis of peri-implantitis, the clinical criteria are as follows: • bleeding and/or suppuration during light probing; • probing depth of ≥ 3 mm; • loss of bone level ≥ 1 mm apical from the most coronary part of the intraosseous part of the implant.

You may qualify if:

  • diagnosed peri-implantitis

You may not qualify if:

  • uncooperative patient
  • younger then 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Dragana Gabrić

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 9, 2023

Study Start

October 1, 2023

Primary Completion

October 20, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

June 9, 2023

Record last verified: 2023-06