Long-term Outcomes of Implants in Patients with Periodontitis (Impl_longterm)

March 3, 2025 updated by: Dr. Antonio Ciardo, Heidelberg University

The aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive periodontal care (SPC). For this purpose, 150 patients with periodontitis and implants are re-examined cross-sectionally (T0), and the changes in the main peri-implant and periodontal target parameters are compared retrospectively at the specified observation time points (T-5, T-7, T-10).

Potential influencing factors to peri-implant conditions include patient-related factors, therapy-related factors and implant-related factors. In addition, patients will be surveyed using validated questionnaires on oral health-related quality of life (OHIP-G14), and a number of common risk factors for periodontits and peri-implant conditions.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

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

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Heidelberg University

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

Yes

Sampling Method

Non-Probability Sample

Study Population

The study cohort is recruited from patients of the Department of Conservative Dentistry at Heidelberg University Hospital who have undergone systematic periodontal therapy, have a dental implant, and meet the other inclusion criteria.

Description

Inclusion Criteria:

Patient-related:

  • At least one dental implant present
  • Age ≥ 18 years at the beginning of the observation period
  • Verbal and written consent
  • Complete periodontal and dental status at one of the defined observation time points with 6 probing sites per tooth/implant and bleeding on probing (BOP) recorded during the periodontal maintenance phase

Locally:

  • a contralateral control tooth to the implant is present at the first defined observation time point
  • BOP recorded on the implant

Exclusion Criteria:

  • No written and verbal consent
  • Younger than 18 years

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
Time Frame
changes in periodontal pocket depths
Time Frame: over five, 7.5, and ten years of supportive periodontal care
over five, 7.5, and ten years of supportive periodontal care

Collaborators and Investigators

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

Sponsor

Heidelberg University

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)

September 1, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-476/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Periodontitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe