Saliva and Dental Calculus in Handicapped People - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 3, 2007

Last Updated Date

April 9, 2009

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

Saliva composition and dental calculus composition

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00495989 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Saliva and Dental Calculus in Handicapped People

Official Title ^†

The Relationship Between Saliva and Dental Calculus in a Population of Institutionalized Handicapped Persons

Brief Summary

This is an evaluation of potential differences in saliva composition and dental calculus composition between orally fed and tube fed individuals in an institutional environment.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Open Label, Active Control, Single Group Assignment, Safety Study

Condition ^†

Disabled Persons

Intervention ^†

Procedure: saliva sampling + dental calculus collection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

100

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

handicapped (mentally and/or physically) persons in an institute
older than 5 years of age
both sexes
full medical records available

Exclusion Criteria:

healthy individuals
disabled individuals not staying in an institution

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00495989

Responsible Party

Johan Aps, University Hospital Ghent

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Ghent

Collaborators ^††

Investigators ^†

Principal Investigator:

Johan Aps, DDS, MSc, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.