Early Childhood Caries (ECC)CariStigmaNCT05284279
Early Childhood Caries and Health Professionals' Perception: a Qualitative Research Protocol to Assess Oral Health Stigma
An observational study of Early Childhood Caries (ECC), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Dental caries is the most common non-communicable disease in childhood. Disease management of caries rests on surgical treatment as well as various preventive strategies such as fluoridation, sealants, personal counselling... Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries (ECC)
- What is being tested?
- Exploring health professionals' perceptions of patients with ECC using semi-structured interviews
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Sep 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants' selection will be conducted on a semirandom basis, directly from the network of the research team members and from regional professional listings of each specialty (general practitioners, pediatricians, general dentists, pediatric dentists). The sample will be constituted with a maximum variation in age, gender, years in practice, occupation and types of practice (solo, group or interdisciplinary team).
Who may be able to join
- speak French fluently
- practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician
- work in hospital or ambulatory facility
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
Marc CHANELIERE contact
France1 site
As much as possible, interviews will be performed face to face at a location convenient to the respondent or using videoconference due to COVID19 pandemic context.
Rhone-Alpes Region
Guillemette LIENHART, MD, 06.20.66.37.37 ext. +33, Guillemette.lienhart@chu-lyon.fr
About this study
Dental caries is the most common non-communicable disease in childhood. Disease management of caries rests on surgical treatment as well as various preventive strategies such as fluoridation, sealants, personal counselling...
With other non-communicable diseases (obesity, overweight…), it has been demonstrated that health professionals' negative perceptions of their patients could affect disease management quality. Concerning dental caries, some data might suggest that discriminating believes and behaviours toward children with dental caries and their families exist in the medical setting. However, oral health related stigma remains an unexplored issue. This study would be the first to our knowledge to specifically address the question of stigmatisation and discrimination of patients with dental caries. The present project is to conduct an exploratory study focusing on perceptions and attitudes of health professionals toward children with early childhood caries and their parents.
Read more
The questions the study aims to answer are: (i) What are health professionals 'perceptions of children with ECC and their family? And (ii) according to health professionals, do these perceptions influence the quality of their care? We hypothesize that some practitioners have negative opinions on children with ECC and their parents, affecting the quality of their care, especially concerning oral health prevention.
Method: Individual semi-structured interviews will be conducted among dentists (general or pediatric), general practitioners and paediatricians.
- Conditions
- Early Childhood Caries (ECC)
- Being tested
- Exploring health professionals' perceptions of patients with ECC using semi-structured interviews
- Keywords
- Dental caries, Social stigma, child, qualitative study
- Medical subject headings
- Dental Caries, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploring health professionals' perceptions of patients with ECC using semi-structured interviewsOther
Following a literature review on the topic of children with ECC and their family, a guidebook will be built by main investigators. Several test interviews will be conduct to ensure that guidebook is adapted, and that the interviewer is enough trained.
Interview will be conducted by one or two of the main investigators. As much as possible, they will be performed face to face or using videoconference due to COVID19 pandemic context. All the interviews will be audio recorded. The interviewer will take notes including non-verbal communication; and will adopt an active listening position.
After collecting respondents' characteristics (age, gender, profession, exercise duration, type of practice), the subsequent themes will be explored: disease perception, educational context's responsibility, barriers and facilitators to family behaviour changes, health professional's emotional consequences.
| Study group | Role | What they receive |
|---|---|---|
| Health professionals practicing with children | To participate, health professionals will have to speak French fluently, practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician and work in hospital or ambulatory facility. As paediatricians and general practitioners meet the child regularly during the first 6 years of life for medical follow-up, they are key stakeholders in the early detection of caries, referrals to dentist and counselling.
The participants will be recruited using a semi-random sampling method. The sample will be constituted with a maximum variation in age, gender, years in practice, occupation and types of practice (solo, group or interdisciplinary team). Receives: Other: Exploring health professionals' perceptions of patients with ECC using semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health professionals' representations of children with dental caries and their family
Individual semi-structured interviews will be conducted among dentists, general practitioners and paediatricians to explore health professionals' representations of children with dental caries and their family. All the interviews will be audio recorded and transcribed into verbatims. Verbatims will be analysed using the N'Vivo qualitative analysis software. The thematic analysis of the data will then be carried out using the 6-steps method of Braun and Clarke. A transversal analysis will be conducted by classifying the verbatims of each interview into themes and main theme.
Measured: The main outcome will be collected during the interviews.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Childhood Caries (ECC)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284279
- Sponsor's protocol ID
- 69HCL21_1182
- Acronym
- CariStigma
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lienhart G, Thivichon-Prince B, Farge P, Schott-Pethelaz AM, Chaneliere M. What are health professionals' perceptions and attitudes regarding children with early childhood caries and their families? A qualitative research protocol to assess oral health stigma in the medical setting. BMJ Open. 2022 Dec 1;12(12):e066680. doi: 10.1136/bmjopen-2022-066680.
PubMed 36455999
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Caries and Health Professionals' Perception: a Qualitative Research Protocol to Assess Oral Health Stigma
- ClinicalTrials.gov ID
- NCT05284279
- Acronym / sponsor ID
- CariStigma / 69HCL21_1182
- Conditions
- Early Childhood Caries (ECC)
- Keywords
- Dental caries, Social stigma, child, qualitative study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 17 Mar 2022 (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.
Dental caries is the most common non-communicable disease in childhood. Disease management of caries rests on surgical treatment as well as various preventive strategies such as fluoridation, sealants, personal counselling...
With other non-communicable diseases (obesity, overweight…), it has been demonstrated that health professionals' negative perceptions of their patients could affect disease management quality. Concerning dental caries, some data might suggest that discriminating believes and behaviours toward children with dental caries and their families exist in the medical setting. However, oral health related stigma remains an unexplored issue. This study would be the first to our knowledge to specifically address the question of stigmatisation and discrimination of patients with dental caries. The present project is to conduct an exploratory study focusing on perceptions and attitudes of health professionals toward children with early childhood caries and their parents.
The questions the study aims to answer are: (i) What are health professionals 'perceptions of children with ECC and their family? And (ii) according to health professionals, do these perceptions influence the quality of their care? We hypothesize that some practitioners have negative opinions on children with ECC and their parents, affecting the quality of their care, especially concerning oral health prevention.
Method: Individual semi-structured interviews will be conducted among dentists (general or pediatric), general practitioners and paediatricians.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health professionals practicing with children | – | Other: Exploring health professionals' perceptions of patients with ECC using semi-structured interviewsTo participate, health professionals will have to speak French fluently, practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician and work in hospital or ambulatory facility. As paediatricians and general practitioners meet the child regularly during the first 6 years of life for medical follow-up, they are key stakeholders in the early detection of caries, referrals to dentist and counselling. The participants will be recruited using a semi-random sampling method. The sample will be constituted with a maximum variation in age, gender, years in practice, occupation and types of practice (solo, group or interdisciplinary team). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants' selection will be conducted on a semirandom basis, directly from the network of the research team members and from regional professional listings of each specialty (general practitioners, pediatricians, general dentists, pediatric dentists). The sample will be constituted with a maximum variation in age, gender, years in practice, occupation and types of practice (solo, group or interdisciplinary team).
Key inclusion criteria (3 listed)
- speak French fluently
- practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician
- work in hospital or ambulatory facility
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Exploring health professionals' perceptions of patients with ECC using semi-structured interviewsFollowing a literature review on the topic of children with ECC and their family, a guidebook will be built by main investigators. Several test interviews will be conduct to ensure that guidebook is adapted, and that the interviewer is enough trained. Interview will be conducted by one or two of the main investigators. As much as possible, they will be performed face to face or using videoconference due to COVID19 pandemic context. All the interviews will be audio recorded. The interviewer will take notes including non-verbal communication; and will adopt an active listening position. After collecting respondents' characteristics (age, gender, profession, exercise duration, type of practice), the subsequent themes will be explored: disease perception, educational context's responsibility, barriers and facilitators to family behaviour changes, health professional's emotional consequences. | Other | Health professionals practicing with children |
Primary outcome
Health professionals' representations of children with dental caries and their family
Time frame: The main outcome will be collected during the interviews.
Individual semi-structured interviews will be conducted among dentists, general practitioners and paediatricians to explore health professionals' representations of children with dental caries and their family. All the interviews will be audio recorded and transcribed into verbatims. Verbatims will be analysed using the N'Vivo qualitative analysis software. The thematic analysis of the data will then be carried out using the 6-steps method of Braun and Clarke. A transversal analysis will be conducted by classifying the verbatims of each interview into themes and main theme.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 36455999Lienhart G, Thivichon-Prince B, Farge P, Schott-Pethelaz AM, Chaneliere M. What are health professionals' perceptions and attitudes regarding children with early childhood caries and their families? A qualitative research protocol to assess oral health stigma in the medical setting. BMJ Open. 2022 Dec 1;12(12):e066680. doi: 10.1136/bmjopen-2022-066680.
- Individual participant dataSharing planned: Undecided
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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.
Marc CHANELIERE contact
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 Early Childhood Caries (ECC), run by Hospices Civils de Lyon 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillemette LIENHART, MD (06.20.66.37.37 ext. +33, Guillemette.lienhart@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health professionals' representations of children with dental caries and their family (time frame: The main outcome will be collected during the interviews.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284279, which also lists 1 linked publication.
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 17 Mar 2022.