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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04281056
Other study ID # APHP190340
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2020
Est. completion date July 2020

Study information

Verified date February 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Adeline Braud, Doctor
Phone 01 40 19 39 87
Email adeline.braud@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
France Service odontologie Hôpital Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary taste detection thresholds Using an Electrogustometer up to 30 days
Secondary Chemical taste identification ability Using taste strips (Burghard) up to 30 days
Secondary Quantitative sensory testing Using an algometer, von frey filament, a thermode. up to 30 days
Secondary Food preferences and selectivity Questionnaire food selectyivity and preference (Maitre et al., 2014) up to 30 days
Secondary Taste appetence Questionnaire PrefQuest (Deglaire et al., 2012) up to 30 days
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