NCT04983758

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 6, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 6, 2021

Last Update Submit

July 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant survival rate

    Change in percentage of dental implants in situ / dental implants placed

    Baseline; 10-year at the 20-year follow-up examination

Secondary Outcomes (1)

  • Marginal Bone loss

    Baseline; 10-year at the 20-year follow-up examination

Study Arms (3)

PHP

Other: Oral Rehabilitation with dental implants

Moderate PCP

Other: Oral Rehabilitation with dental implants

Severe PCP

Other: Oral Rehabilitation with dental implants

Interventions

Patients have been treated with oral dental implants supporting fixed dental prostheses

Moderate PCPPHPSevere PCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Torino

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Peri-ImplantitisBone Diseases, Metabolic

Interventions

RehabilitationDental Implants

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesDental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mario Roccuzzo

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 30, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

July 1, 2023

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations