- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983758
20-year Implant Survival in Periodontally Healthy and Compromised Patients
July 28, 2021 updated by: Mario Roccuzzo, University of Turin, Italy
Long-term (20-year) Implant Survival and Success Rates in Patients Healthy and Compromised Patients
The aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mario Roccuzzo
- Phone Number: +390117714732
- Email: mario.roccuzzo@unito.it
Study Locations
-
-
-
Torino, Italy
- Recruiting
- University of Torino
-
Contact:
- Mario Roccuzzo
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients attending the principle investigator (M.R.), a specialist in periodontology, for dental implant therapy between December 1998 and September 2001 were screened for possible inclusion in the study.
Description
Inclusion Criteria:
- complete edentulism;
- presence of an implant-supported overdenture;
- mucosal diseases;
- alcohol and drug abuse;
- pregnancy;
- uncontrolled metabolic disorders;
- aggressive periodontitis;
- no interest in participating in the study
Exclusion Criteria:
- Everything not as Inclusion Criteria
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PHP
|
Patients have been treated with oral dental implants supporting fixed dental prostheses
|
|
Moderate PCP
|
Patients have been treated with oral dental implants supporting fixed dental prostheses
|
|
Severe PCP
|
Patients have been treated with oral dental implants supporting fixed dental prostheses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant survival rate
Time Frame: Baseline; 10-year at the 20-year follow-up examination
|
Change in percentage of dental implants in situ / dental implants placed
|
Baseline; 10-year at the 20-year follow-up examination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone loss
Time Frame: Baseline; 10-year at the 20-year follow-up examination
|
Changes in mm of the peri-implant marginal bone loss
|
Baseline; 10-year at the 20-year follow-up examination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
July 6, 2021
First Submitted That Met QC Criteria
July 28, 2021
First Posted (Actual)
July 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 30, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 168/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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