- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281056
Impact of Tooth Loss and Denture on Oral Senses and Food Preferences (AlimaPAC)
Impact of Complete Tooth Loss and Denture on Oral Sensory Abilities and Food Preference
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adeline Braud, Doctor
- Phone Number: 01 40 19 39 87
- Email: adeline.braud@aphp.fr
Study Contact Backup
- Name: Yves Boucher, Professor
Study Locations
-
-
-
Paris, France, 75002
- Service odontologie Hôpital Rothschild
-
Contact:
- Adeline Braud, Dr
- Phone Number: 01 40 19 39 87
- Email: adeline.braud@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Tooth removal
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
|
Teeth have been removed and replaced by means of dentures for at least one year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
taste detection thresholds
Time Frame: up to 30 days
|
Using an Electrogustometer
|
up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chemical taste identification ability
Time Frame: up to 30 days
|
Using taste strips (Burghard)
|
up to 30 days
|
Quantitative sensory testing
Time Frame: up to 30 days
|
Using an algometer, von frey filament, a thermode.
|
up to 30 days
|
Food preferences and selectivity
Time Frame: up to 30 days
|
Questionnaire food selectyivity and preference (Maitre et al., 2014)
|
up to 30 days
|
Taste appetence
Time Frame: up to 30 days
|
Questionnaire PrefQuest (Deglaire et al., 2012)
|
up to 30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Adeline Braud, Doctor, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP190340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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