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Saliva and Dental Calculus in Handicapped People

Primary Purpose

Disabled Persons

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
saliva sampling + dental calculus collection
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disabled Persons focused on measuring Handicapped individuals

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Outcomes

Primary Outcome Measures

Saliva composition and dental calculus composition

Secondary Outcome Measures

Full Information

First Posted
July 3, 2007
Last Updated
July 5, 2021
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00495989
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disabled Persons
Keywords
Handicapped individuals

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
saliva sampling + dental calculus collection
Primary Outcome Measure Information:
Title
Saliva composition and dental calculus composition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Aps, DDS, MSc, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

Saliva and Dental Calculus in Handicapped People

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