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Impact of Tooth Loss and Denture on Oral Senses and Food Preferences (AlimaPAC)

Primary Purpose

Tooth-loss

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tooth removal and their replacement by means of a denture
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tooth-loss focused on measuring Teeth loss, edentulousness, denture, tast, trigeminal senses, oral sensory ability

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Study Group : being completely edentulous and wearing denture for at least one year, wearing denture during meals, with clean and stable dentures. Controls:

controls Group : dentate subjects (25 teeth at leas, non endodontically treated) with molars in Angle's Class I occlusion, having no functional disturbance of mastication and not undergoing dental treatment at the time of the recording. Matched with subjects of the study group for age, sex, tabacco consumption, and saliva flow rate.

Exclusion Criteria:

  • Aged under 18 or over 80 Y,
  • not consenting to participate
  • suffering from dental
  • periodontal or gum pain for the last month.

Sites / Locations

  • Service odontologie Hôpital Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Tooth removal

Arm Description

Tooth removal and their replacement by means of a denture Teeth have been removed and replaced by means of dentures for at least one year

Outcomes

Primary Outcome Measures

taste detection thresholds
Using an Electrogustometer

Secondary Outcome Measures

Chemical taste identification ability
Using taste strips (Burghard)
Quantitative sensory testing
Using an algometer, von frey filament, a thermode.
Food preferences and selectivity
Questionnaire food selectyivity and preference (Maitre et al., 2014)
Taste appetence
Questionnaire PrefQuest (Deglaire et al., 2012)

Full Information

First Posted
February 20, 2020
Last Updated
February 20, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04281056
Brief Title
Impact of Tooth Loss and Denture on Oral Senses and Food Preferences
Acronym
AlimaPAC
Official Title
Impact of Complete Tooth Loss and Denture on Oral Sensory Abilities and Food Preference
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Tooth loss impacts taste abilities and food intake. Present study aims at pertaining the impact of teeth loss and the replacement by means of complete denture on taste and trigeminal abilities, and on food preferences, and taste appetence.
Detailed Description
Two groups of participants will be included. Participants wearing complete denture for at least one year (n=20) and their matched controls for age, sex, tobacco, and saliva secretion (n=20). Their oral sensory abilities of participants will be assessed including taste (electrogustometric thresholds, chemical taste identification ability) and trigeminal quantitative sensory testing. Food preferences and selectivity (Maitre et al., 2014) and taste appetence (Deglaire et al., 2012) will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth-loss
Keywords
Teeth loss, edentulousness, denture, tast, trigeminal senses, oral sensory ability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Tooth removal
Arm Type
Experimental
Arm Description
Tooth removal and their replacement by means of a denture Teeth have been removed and replaced by means of dentures for at least one year
Intervention Type
Procedure
Intervention Name(s)
Tooth removal and their replacement by means of a denture
Intervention Description
Teeth have been removed and replaced by means of dentures for at least one year
Primary Outcome Measure Information:
Title
taste detection thresholds
Description
Using an Electrogustometer
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Chemical taste identification ability
Description
Using taste strips (Burghard)
Time Frame
up to 30 days
Title
Quantitative sensory testing
Description
Using an algometer, von frey filament, a thermode.
Time Frame
up to 30 days
Title
Food preferences and selectivity
Description
Questionnaire food selectyivity and preference (Maitre et al., 2014)
Time Frame
up to 30 days
Title
Taste appetence
Description
Questionnaire PrefQuest (Deglaire et al., 2012)
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study Group : being completely edentulous and wearing denture for at least one year, wearing denture during meals, with clean and stable dentures. Controls: controls Group : dentate subjects (25 teeth at leas, non endodontically treated) with molars in Angle's Class I occlusion, having no functional disturbance of mastication and not undergoing dental treatment at the time of the recording. Matched with subjects of the study group for age, sex, tabacco consumption, and saliva flow rate. Exclusion Criteria: Aged under 18 or over 80 Y, not consenting to participate suffering from dental periodontal or gum pain for the last month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline Braud, Doctor
Phone
01 40 19 39 87
Email
adeline.braud@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yves Boucher, Professor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Braud, Doctor
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service odontologie Hôpital Rothschild
City
Paris
ZIP/Postal Code
75002
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeline Braud, Dr
Phone
01 40 19 39 87
Email
adeline.braud@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Tooth Loss and Denture on Oral Senses and Food Preferences

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