Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06140654
Other study ID # 17-BRAU-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 30, 2020

Study information

Verified date November 2023
Source Hôpital Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The study population included 125 participants, recruited within the general population and in a dental clinic: -Non-dental group included 62 non-seeking dental treatment subjects, aged 30-65 years, previously recruited during the OralPom survey. -Dental group included 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). Both groups took part in an individual session with a dental practitioner during which food selectivity, medical history, and oral health status were assessed.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Clinical oral examination
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.
Food behavior
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".

Locations

Country Name City State
France Université de Paris Paris

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05977348 - Increasing Food Literacy in Preschoolers to Reduce Obesity Risk N/A
Completed NCT02565472 - Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects N/A
Enrolling by invitation NCT02403882 - Behavioral Economic Interventions at Food Pantries N/A
Completed NCT01792596 - Satiety Effects of Protein and Fiber Added to Pasta N/A
Active, not recruiting NCT04262102 - The Dastatuz Project N/A
Terminated NCT03283033 - School Lunch Salad Bars and Fruit and Vegetable Consumption N/A
Completed NCT04165447 - Evaluating the Effectiveness of Within Versus Across-Category Front-of-Package Lower-Calorie Labelling on Food Demand N/A
Completed NCT02804503 - The Effect of Menu Labels on Calories Ordered in Hispanics N/A
Recruiting NCT05442424 - Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii N/A
Completed NCT05595551 - Process and Effect Evaluation of the Project "Aan Tafel in 1,2,3 Euro" N/A
Recruiting NCT05664256 - Evaluation of a Healthy Food Procurement Policy at Municipality-level in Nepal N/A
Completed NCT04909372 - Environmental Labelling in a Virtual Supermarket N/A
Completed NCT02667184 - The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Healthy Human Subjects N/A
Terminated NCT04243252 - A Trial of Traffic Light Labeling With Behavioral Nudges and a Healthy Recipe Database to Increase Selection of Healthier Foods in Client-choice Food Pantries N/A
Completed NCT05482204 - Do Sustainability Labels Lead to More Sustainable and Healthier Food Choices? N/A
Completed NCT01903499 - Satiety Effects of Beef Compared to Beans N/A
Completed NCT04152785 - Measurement of Greenhouse Gas Emissions From Meals of a University Food Operator N/A
Completed NCT04302792 - New Food Solutions for Cancer Patients N/A
Recruiting NCT05922098 - Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult N/A
Completed NCT04919668 - Effect of Gamification in an Online Grocery Store. N/A