20-year Implant Survival in Periodontally Healthy and Com... | NCT04983758

Studies
20-year Implant Survival in Periodontally Healthy and Compromised Patients

NCT04983758

Sponsor

University of Turin, Italy

Status

Unknown status

Last Update Posted

Jul 30, 2021Actual

Enrollment

149Estimated

Phase

Not provided

Conditions

Dental Implant Failed
Peri-Implantitis
Bone Loss

Interventions

Oral Rehabilitation with dental implants

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Estimated

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Jul 6, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Jul 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Jul 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

149Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PHP			Other: Oral Rehabilitation with dental implants
Moderate PCP			Other: Oral Rehabilitation with dental implants
Severe PCP			Other: Oral Rehabilitation with dental implants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Rehabilitation with dental implants	Other	Patients have been treated with oral dental implants supporting fixed dental prostheses	Moderate PCP PHP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Marginal Bone loss	Changes in mm of the peri-implant marginal bone loss	Baseline; 10-year at the 20-year follow-up examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mario Roccuzzo	Contact	+390117714732		mario.roccuzzo@unito.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Torino	Recruiting	Torino			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation
D015921	Dental Implants

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided