Dental CariesNCT06863103
Treating Children With Extensive Dental Needs
An observational study of Dental Caries and Tooth Extraction, run by Malmö University at 1 site in Sweden.
Trial summary
The goal of this qualitative study, using Grounded Theory, is to gain deeper knowledge about dentists' experiences from treating in particular young children with an extensive treatment need (mainly due to caries). Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Tooth Extraction, Conscious Sedation
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 26 Mar 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Dentists, both general dental practitioners and specialist, or those under training to become specialist in pediatric dentistry.
Who may be able to join
- Dentists, both general dental practitioners and specialist, or those under training to become specialist in pediatric dentistry.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dentists' Experiences From Treating Children With Extensive Dental Treatment Needs
The goal of this qualitative study, using Grounded Theory, is to gain deeper knowledge about dentists' experiences from treating in particular young children with an extensive treatment need (mainly due to caries).
The main question is to find out more about the dentists' reactions, feelings, perceived stress, and thoughts in general when meeting and treating young children with many carious lesions. The investigators also want to gain better understanding of how dentists think about reporting children who might be subject for maltreatment.
Read the detailed description
BACKGROUND: Severe or extensive caries is a condition that affects a large number of children yearly. This could lead to serious consequences for the affected child such as pain, many dental visits, risk for poorer oral health, and poor esthetics. In many cases, there is a connection to lack of care, whereby dental professionals has an obligation to file a report to social services regarding concerns of maltreatment.
The dental care includes a wide spectrum of measures, from information och oral health preventive actions, to filling therapies and tooth extractions. I many cases the disease is so extensive that the child needs to be referred to a pediatric dentistry specialist clinic in order to get treatment under sedation or general anesthesia. This is more prevalent the younger the child is. Dental treatments performed under general anesthesia or sedation is often more radical and tooth extraction is a common therapy for teeth with extensive decay.
As a dentist, in charge of initial care and treatment, taking care of children who might not know or understand why they have to undergo treatment, or that maybe are scared or suffer from pain, might affect the general wellbeing of the dentist. Perception of stress, especially ethical stress, can further affect how dentists make treatment decisions, among other things. Despite this, the knowledge of how dentists perceive and are affected by meeting and treating children with extensive need for dental care, is unsatisfactory.
RESEARCH QUESTION How do dentists experience meeting and treating children with an extensive need for dental care? How is extensive need for dental care looked upon in relation to potential report to social services?
METHODS AND INFORMANTS This project will use Grounded Theory, that is a qualitative research method. When knowledge and theories are lacking within a certain area, common hypotheses testing methods are less suitable. Instead, by using qualitative research methods, information can be collected from individuals with experience from the area of interest. Some methods, like Grounded Theory, can lead to results that might form a base for formulating hypothesis that later can be tested in studies using quantitative/hypotheses testing methods.
In this project, interviews will be held with dentists (informants) that work within public dental care, and specialised dental care, i.e. specialists in pediatric dentistry. During the interviews a so called thematic interview guide with open themes is used, rather than using semi-structured that might lead what the informants choose to talk about. Intended themes in the interview guide concerns the following: experiences of treating children with extensive need for treatment, reflections upon reporting to social services, experiences of child patients reactions and abilities to handle dental treatment, thoughts about legal guardians being present in the operating room, experiences of different coping strategies, or anything else that the informant brings to the table. Informants will be general dental practitioners working with child dental care, mainly from county of Scania, and specialist in pediatric dentistry or post-graduate students becoming such specialists. The specialist cohort is recruited from all over Sweden.
The investigators plan to interview up to 25 dentists. The informants will be recruited to include different experiences, and backgrounds, e.g. different ages, years as dentist, general dental practitioner or specialist, public dental clinic or private clinic, working in city or rural area.
The interviews will take approximately one hour and will be recorded digitally, and the interviews can be performed both digitally or in a direct meeting, but over telephone is also a possibility. The interviews will be transcribed verbatim and analyzed according to preset routines according to to the chosen method, Grounded Theory. Interviews and analyses takes place parallell. The transcribed interviews will be analyzed, and through these analyses so called categories emerges, that describes what the experiences are about. These codes will then be merged into preliminary categories. In the following axial coding process, the preliminary categories will be further developed by identifying dimensions and characteristics, leading up to sub-categories. Relations data and categories is sought for, thus creating a "new whole". Selective coding will lead to data saturation and validation. The former can also be achieved by re-code already retreived data. In the results, there is also a core category that can be described as the most central and crucial aspects of the research questions being studied.
it is not applicable to calculate sample size when using qualitative method such as Grounded Theory. Instead, participants will be included until saturation in data is achieved, meaning that new information can not any longer be obtained.
KNOWLEDGE GAINS Grounded Theory is a theory generating method, especially suitable for research areas where existing theories are scarce or totally lacking. Today, a lot of research within medical and dental fields takes the investigator's perspective. It is highly crucial that also the directly affected are involved, i.e. the patients.
- Keywords
- grounded theory, dentist, pediatric dentistry, dental caries, ethical stress
- Medical subject headings
- Dental Caries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child-treating dentists | Dentists meeting young children with extensive treatment need |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentists' attitudes on handling children with extensive treatment need
This study aims to identify and categorize the main themes that emerge from qualitative interviews with dentists who treat children with extensive dental needs. The themes will be derived using grounded theory methodology, focusing on the challenges, strategies, and outcomes associated with providing care to this patient population. By analyzing data, codes will be identified, leading up to conceptual categories that in the end will form a core-category, a new theory.
Measured: The data will be collected and analyzed over a period of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start26 Mar 2024
- Primary completion25 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Berlin, PhD, Principal investigator, Malmö University, Faculty of Odontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863103
- Sponsor's protocol ID
- MAU 2024/122
- Status last verified
- May 2025
- First submitted
- 5 Dec 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
PubMed 25740856Griffen AL, Schneiderman LJ. Ethical issues in managing the noncompliant child. Pediatr Dent. 1992 May-Jun;14(3):178-83.
PubMed 1528787Farokh-Gisour E, Hatamvand M. Investigation of Stress Level Among Dentistry Students, General Dentists, and Pediatric Dental Specialists During Performing Pediatric Dentistry in Kerman, Iran, in 2017. Open Dent J. 2018 Sep 28;12:631-637. doi: 10.2174/1745017901814010631. eCollection 2018.
PubMed 30369972"Dellve L, Henning Abrahamsson K, Trulsson U, Hallberg LR-M. Grounded theory in public health research. In: Hallberg LR-M, ed. Qualitative methods in public health research: theoretical foundations and practical examples. Lund: Studentlitteratur, 2002; 137-173."
Kvist T, Wickstrom A, Miglis I, Dahllof G. The dilemma of reporting suspicions of child maltreatment in pediatric dentistry. Eur J Oral Sci. 2014 Oct;122(5):332-8. doi: 10.1111/eos.12143. Epub 2014 Jul 11.
PubMed 25039643Kizilci E, Kizilay F, Mahyaddinova T, Muhtaroglu S, Kolcakoglu K. Stress levels of a group of dentists while providing dental care under clinical, deep sedation, and general anesthesia. Clin Oral Investig. 2023 Jul;27(7):3601-3609. doi: 10.1007/s00784-023-04973-9. Epub 2023 Mar 30.
PubMed 36995430Glaser B, Strauss A. The discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter, 1967.
Davidovich E, Pessov Y, Baniel A, Ram D. Levels of Stress among General Practitioners, Students and Specialists In Pediatric Dentistry during Dental Treatment. J Clin Pediatr Dent. 2015 Fall;39(5):419-22. doi: 10.17796/1053-4628-39.5.419.
PubMed 26551363
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentists' Experiences From Treating Children With Extensive Dental Treatment Needs
- ClinicalTrials.gov ID
- NCT06863103
- Acronym / sponsor ID
- MAU 2024/122
- Keywords
- grounded theory, dentist, pediatric dentistry, dental caries, ethical stress
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 7 Mar 2025 (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 goal of this qualitative study, using Grounded Theory, is to gain deeper knowledge about dentists' experiences from treating in particular young children with an extensive treatment need (mainly due to caries).
The main question is to find out more about the dentists' reactions, feelings, perceived stress, and thoughts in general when meeting and treating young children with many carious lesions. The investigators also want to gain better understanding of how dentists think about reporting children who might be subject for maltreatment.
Detailed description
BACKGROUND: Severe or extensive caries is a condition that affects a large number of children yearly. This could lead to serious consequences for the affected child such as pain, many dental visits, risk for poorer oral health, and poor esthetics. In many cases, there is a connection to lack of care, whereby dental professionals has an obligation to file a report to social services regarding concerns of maltreatment.
The dental care includes a wide spectrum of measures, from information och oral health preventive actions, to filling therapies and tooth extractions. I many cases the disease is so extensive that the child needs to be referred to a pediatric dentistry specialist clinic in order to get treatment under sedation or general anesthesia. This is more prevalent the younger the child is. Dental treatments performed under general anesthesia or sedation is often more radical and tooth extraction is a common therapy for teeth with extensive decay.
As a dentist, in charge of initial care and treatment, taking care of children who might not know or understand why they have to undergo treatment, or that maybe are scared or suffer from pain, might affect the general wellbeing of the dentist. Perception of stress, especially ethical stress, can further affect how dentists make treatment decisions, among other things. Despite this, the knowledge of how dentists perceive and are affected by meeting and treating children with extensive need for dental care, is unsatisfactory.
RESEARCH QUESTION How do dentists experience meeting and treating children with an extensive need for dental care? How is extensive need for dental care looked upon in relation to potential report to social services?
METHODS AND INFORMANTS This project will use Grounded Theory, that is a qualitative research method. When knowledge and theories are lacking within a certain area, common hypotheses testing methods are less suitable. Instead, by using qualitative research methods, information can be collected from individuals with experience from the area of interest. Some methods, like Grounded Theory, can lead to results that might form a base for formulating hypothesis that later can be tested in studies using quantitative/hypotheses testing methods.
In this project, interviews will be held with dentists (informants) that work within public dental care, and specialised dental care, i.e. specialists in pediatric dentistry. During the interviews a so called thematic interview guide with open themes is used, rather than using semi-structured that might lead what the informants choose to talk about. Intended themes in the interview guide concerns the following: experiences of treating children with extensive need for treatment, reflections upon reporting to social services, experiences of child patients reactions and abilities to handle dental treatment, thoughts about legal guardians being present in the operating room, experiences of different coping strategies, or anything else that the informant brings to the table. Informants will be general dental practitioners working with child dental care, mainly from county of Scania, and specialist in pediatric dentistry or post-graduate students becoming such specialists. The specialist cohort is recruited from all over Sweden.
The investigators plan to interview up to 25 dentists. The informants will be recruited to include different experiences, and backgrounds, e.g. different ages, years as dentist, general dental practitioner or specialist, public dental clinic or private clinic, working in city or rural area.
The interviews will take approximately one hour and will be recorded digitally, and the interviews can be performed both digitally or in a direct meeting, but over telephone is also a possibility. The interviews will be transcribed verbatim and analyzed according to preset routines according to to the chosen method, Grounded Theory. Interviews and analyses takes place parallell. The transcribed interviews will be analyzed, and through these analyses so called categories emerges, that describes what the experiences are about. These codes will then be merged into preliminary categories. In the following axial coding process, the preliminary categories will be further developed by identifying dimensions and characteristics, leading up to sub-categories. Relations data and categories is sought for, thus creating a "new whole". Selective coding will lead to data saturation and validation. The former can also be achieved by re-code already retreived data. In the results, there is also a core category that can be described as the most central and crucial aspects of the research questions being studied.
it is not applicable to calculate sample size when using qualitative method such as Grounded Theory. Instead, participants will be included until saturation in data is achieved, meaning that new information can not any longer be obtained.
KNOWLEDGE GAINS Grounded Theory is a theory generating method, especially suitable for research areas where existing theories are scarce or totally lacking. Today, a lot of research within medical and dental fields takes the investigator's perspective. It is highly crucial that also the directly affected are involved, i.e. the patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child-treating dentists | – | –Dentists meeting young children with extensive treatment need |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dentists, both general dental practitioners and specialist, or those under training to become specialist in pediatric dentistry.
Key inclusion criteria (1 listed)
- Dentists, both general dental practitioners and specialist, or those under training to become specialist in pediatric dentistry.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dentists' attitudes on handling children with extensive treatment need
Time frame: The data will be collected and analyzed over a period of 12 months.
This study aims to identify and categorize the main themes that emerge from qualitative interviews with dentists who treat children with extensive dental needs. The themes will be derived using grounded theory methodology, focusing on the challenges, strategies, and outcomes associated with providing care to this patient population. By analyzing data, codes will be identified, leading up to conceptual categories that in the end will form a core-category, a new theory.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 25740856Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
- Background: PubMed 1528787Griffen AL, Schneiderman LJ. Ethical issues in managing the noncompliant child. Pediatr Dent. 1992 May-Jun;14(3):178-83.
- Background: PubMed 30369972Farokh-Gisour E, Hatamvand M. Investigation of Stress Level Among Dentistry Students, General Dentists, and Pediatric Dental Specialists During Performing Pediatric Dentistry in Kerman, Iran, in 2017. Open Dent J. 2018 Sep 28;12:631-637. doi: 10.2174/1745017901814010631. eCollection 2018.
- Background"Dellve L, Henning Abrahamsson K, Trulsson U, Hallberg LR-M. Grounded theory in public health research. In: Hallberg LR-M, ed. Qualitative methods in public health research: theoretical foundations and practical examples. Lund: Studentlitteratur, 2002; 137-173."
- Background: PubMed 25039643Kvist T, Wickstrom A, Miglis I, Dahllof G. The dilemma of reporting suspicions of child maltreatment in pediatric dentistry. Eur J Oral Sci. 2014 Oct;122(5):332-8. doi: 10.1111/eos.12143. Epub 2014 Jul 11.
- Background: PubMed 36995430Kizilci E, Kizilay F, Mahyaddinova T, Muhtaroglu S, Kolcakoglu K. Stress levels of a group of dentists while providing dental care under clinical, deep sedation, and general anesthesia. Clin Oral Investig. 2023 Jul;27(7):3601-3609. doi: 10.1007/s00784-023-04973-9. Epub 2023 Mar 30.
- BackgroundGlaser B, Strauss A. The discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter, 1967.
- Results publication: PubMed 26551363Davidovich E, Pessov Y, Baniel A, Ram D. Levels of Stress among General Practitioners, Students and Specialists In Pediatric Dentistry during Dental Treatment. J Clin Pediatr Dent. 2015 Fall;39(5):419-22. doi: 10.17796/1053-4628-39.5.419.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Henrik Berlin, PhD principal investigator
Malmö University, Faculty of Odontology
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 Dental Caries and Tooth Extraction, run by Malmö University at 1 site in Sweden.
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 1 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: enrolling by invitation, as of the sponsor's last update on 7 May 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Dentists' attitudes on handling children with extensive treatment need (time frame: The data will be collected and analyzed over a period of 12 months.). 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 NCT06863103, which also lists 8 linked publications.
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 7 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.