NCT06140654

Brief Summary

The present study was undertaken in order to describe the clinical profiles of food selective behavior in 35-65 years dental and non-dental populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
Last Updated

November 20, 2023

Status Verified

November 1, 2023

Enrollment Period

3.1 years

First QC Date

November 14, 2023

Last Update Submit

November 18, 2023

Conditions

Keywords

eating behaviorfood preferences

Outcome Measures

Primary Outcomes (1)

  • Food selectivity score

    The food selectivity score measures the number of avoided foods. The score ranges from 0 to 71, 0 meaning no food selectivity and 71 meaning high food selectivity.

    During clinical examination session (1 hour) at baseline

Study Arms (2)

Non-dental group

62 non-seeking dental treatment subjects, aged 30-65 years, previously recruited within the general population from december 2017 to january 2018. Declared painful conditions including temporo-mandibular disorder, cephalalgia, oral or dental pain were initially considered as excluding conditions. Exclusion criteria also included diagnosis of acute orofacial disease (i.e. rhinitis) or sensory trouble (i.e. anosmia, dysgeusia) neither at the time of the experiment nor in the recent past, pregnancy, head and neck irradiation, eating disorders, enteral or parenteral feeding, and cognitive impairment or impaired communication. They took part in an individual session with a dental practitioner of about 30-min during which food selectivity, medical history, and oral health status were assessed.

Diagnostic Test: Clinical oral examinationDiagnostic Test: Food behavior

Dental group

63 patients recruited from September 2019 to December 2020 among patients seeking/pending dental treatment within the university dental clinic of the Rothschild hospital (AP-HP Sorbonne University, Paris, France). Inclusion criteria were: age between 35 and 65 years, literate French speakers, willing and able to complete the survey in a single setting. Patients suffering from cognitive impairment or impaired communication were excluded. They took part in an individual session with a dental practitioner of about 30-min during which food selectivity, medical history, and oral health status were assessed.

Diagnostic Test: Clinical oral examinationDiagnostic Test: Food behavior

Interventions

Clinical oral examinations are conducted by a dental practitioner. They point out the number of teeth (ranging from 0 to 32), the number of occlusal functional units (OFU, ranging from 0 to 10, with one unit considered as a pair of antagonist premolars and molars that had at least one contact area during maximum intercuspal relationships, evaluated by asking the participants to clench on a 200 µm thick articulating paper, the presence of dental prostheses (fixed prosthesis and removable denture), the number of denture worn during meals (removable partial or complete denture, either maxillary or mandibular, or both, with number ranging from 0 to 2), the number of decayed, missing, filled teeth (DMFT index, based on 28 teeth), and the Russel's periodontal index which is presently preferred to the Community (namely CPITN) because it takes tooth mobility into account.

Dental groupNon-dental group
Food behaviorDIAGNOSTIC_TEST

Food selective behavior is assessed using a food selectivity questionnaire previously developed for French adults 34. Participants will be interviewed and asked to check each food item they do not eat among a list of 71 familiar products which includes raw foods and dishes from the following categories: starters, meat, fish, egg, garnish, dairy products, desserts, bread, and beverages. A food selectivity score corresponding to the total number of avoided foods will be assessed for each participant. For each avoided food, participants explain why they do not eat it among reasons including "I don't know it", "I dislike it", "I suffer from chewing or swallowing it (oral discomfort)", "I experience difficulties digesting the food", "This food is forbidden for medical reason", and "This food is forbidden for ethical or religious reasons".

Dental groupNon-dental group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

French adults, aged from 30 to 65 years old.

You may qualify if:

  • Non-dental group : non-seeking dental treatment subjects, aged 30-65 years.
  • Dental group: patients seeking/pending dental treatment within the university dental clinic of the Rothschild hospital (AP-HP Sorbonne University, Paris, France), aged between 35 and 65 years, literate French speakers, willing and able to complete the survey in a single setting.

You may not qualify if:

  • For non dental group :Declared painful conditions including temporo-mandibular disorder, cephalalgia, oral or dental pain, diagnosis of acute orofacial disease (i.e. rhinitis) or sensory trouble (i.e. anosmia, dysgeusia) neither at the time of the experiment nor in the recent past, pregnancy, head and neck irradiation, eating disorders, enteral or parenteral feeding, and cognitive impairment or impaired communication.
  • Patients suffering from cognitive impairment or impaired communication are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Paris

Paris, 75006, France

Location

MeSH Terms

Conditions

Mouth DiseasesFood PreferencesFeeding Behavior

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesBehaviorBehavior, Animal

Study Officials

  • Adeline Braud, PhD

    Unievrsité Paris Cité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in oral rehabilitation

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 20, 2023

Study Start

December 1, 2017

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

November 20, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations