NCT04281056

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Mar 2022Apr 2027

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 16, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

February 20, 2020

Last Update Submit

December 12, 2025

Conditions

Keywords

Teeth lossedentulousnessdenturetasttrigeminal sensesoral sensory ability

Outcome Measures

Primary Outcomes (1)

  • taste detection thresholds

    Using an Electrogustometer

    up to 30 days

Secondary Outcomes (4)

  • Chemical taste identification ability

    up to 30 days

  • Quantitative sensory testing

    up to 30 days

  • Food preferences and selectivity

    up to 30 days

  • Taste appetence

    up to 30 days

Study Arms (2)

Control

NO INTERVENTION

Tooth removal

EXPERIMENTAL

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

Procedure: Tooth removal and their replacement by means of a denture

Interventions

Teeth have been removed and replaced by means of dentures for at least one year

Tooth removal

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service odontologie Hôpital Rothschild

Paris, 75002, France

RECRUITING

MeSH Terms

Conditions

Anodontia

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Adeline Braud, Doctor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline Braud, Doctor

CONTACT

Yves Boucher, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 21, 2020

Study Start

March 16, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations