Classification of Periodontitis Revisited: A Cluster Anal... | NCT03168217

Studies
Classification of Periodontitis Revisited: A Cluster Analysis

NCT03168217

Sponsor

University Paris 7 - Denis Diderot

Status

Unknown status

Last Update Posted

May 30, 2017Actual

Enrollment

235Actual

Phase

Not provided

Conditions

Periodontitis

Interventions

Not provided

Countries

Not provided

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

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Jan 2010Actual

Completion Date

Jun 2017Estimated

First Submitted Date

Jan 17, 2017

First Submission Date that Met QC Criteria

May 25, 2017

First Posted Date

May 30, 2017Actual

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

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hélène Rangé, Clinical Professor, University Paris 7 - Denis DiderotPrincipal Investigator

Lead Sponsor

University Paris 7 - Denis DiderotOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study aims to identify phenotypic groups of patients with periodontitis by applying a cluster analysis.

Detailed Description

This is a retrospective cross-sectional study based on a prospectively maintained database of consecutive patients attending the Departement of Periodontology at the Rothschild hospital. A cluster analysis will help to distinguish clinical and microbiological profils of periodontal patients.

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

235Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Attachment Loss (CAL)	measured in millimeters	one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with periodontitis either aggressive or chronic

Exclusion Criteria:

Patients who had received periodontal therapies or antimicrobial therapy within the 6 months preceding the examination

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

This is a retrospective cross-sectional analysis based on a prospectively maintained database of consecutive patients attending the Department of Periodontology at the Rothschild Hospital of Paris (France)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Bouchard, PhD,DDS	Paris Diderot University	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD Will be shared on request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided