Oral DiseaseNCT06140654
Oral Health-related Patterns of Food Selectivity in Dental Populations
An observational study of Oral Disease and Food Selection, run by Hôpital Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Disease, Food Selection
- What is being tested?
- Clinical oral examination and Food behavior
- Type of treatment
- Pill or oral medicine
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: French adults, aged from 30 to 65 years old.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Quality of Life and Food Intake Survey
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.
Read the 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.
- Conditions
- Oral Disease, Food Selection
- Being tested
- Clinical oral examination, Food behavior
- Keywords
- eating behavior, food preferences
- Medical subject headings
- Mouth Diseases, Food Preferences, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical oral examinationDiagnostic test
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 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".
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Clinical oral examination; Diagnostic 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. Receives: Diagnostic Test: Clinical oral examination; Diagnostic Test: Food behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During clinical examination session (1 hour) at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start1 Dec 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Rothschild
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Braud Adeline, Hôpital Rothschild
- Investigators
- Adeline Braud, PhD, Principal investigator, Unievrsité Paris Cité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140654
- Sponsor's protocol ID
- 17-BRAU-02
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 20 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Quality of Life and Food Intake Survey
- ClinicalTrials.gov ID
- NCT06140654
- Acronym / sponsor ID
- 17-BRAU-02
- Conditions
- Oral Disease, Food Selection
- Keywords
- eating behavior, food preferences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Hôpital RothschildUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-dental group | – | Diagnostic Test: Clinical oral examination, Diagnostic Test: Food behavior62 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. |
| Dental group | – | Diagnostic Test: Clinical oral examination, Diagnostic Test: Food behavior63 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- French adults, aged from 30 to 65 years old.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical oral examinationClinical 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. | Diagnostic test | Dental group, Non-dental group |
| Food behaviorFood 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". | Diagnostic test | Dental group, Non-dental group |
Primary outcome
Food selectivity score
Time frame: During clinical examination session (1 hour) at baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Braud, PhD principal investigator
Unievrsité Paris Cité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Disease and Food Selection, run by Hôpital Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food selectivity score (time frame: During clinical examination session (1 hour) at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2023.