- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140654
Oral Health-related Patterns of Food Selectivity in Dental Populations
Oral Quality of Life and Food Intake Survey
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Paris, France, 75006
- Université de Paris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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 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 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. |
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 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".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food selectivity score
Time Frame: During clinical examination session (1 hour) at baseline
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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.
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During clinical examination session (1 hour) at baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adeline Braud, PhD, Unievrsité Paris Cité
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-BRAU-02
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
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