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PainNCT04643951

Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental Professionals and Students

An observational study of Pain, run by Malmö University at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a qualitative interview study, using Grounded Theory. The aim is to deepen our knowledge about how the dental team (dentists, dental hygienists, and dental assistants) and dental students perceive child patients' pain and how they perceive they are equipped to prevent and deal with child patients' pain and the… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Interview
How many people
35 participants
Where
1 siteSweden
Study dates
1 Dec 2020to 30 Dec 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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 4th and 5th year dental students, and dental professionals (dentists, dental hygienists, dental assistants)

Who may be able to join

  • Dental students in their 4th or 5th year of training
  • Dental professionals working with child patients on a regular basis

Who cannot join

  • Do not understand Swedish language

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rikard Roxner, DDS contact

+46 40 665 84 80

rikard.roxner@mau.se

Henrik Berlin, DDS contact

+46 40 665 84 88

henrik.berlin@mau.se

Sweden1 site, 1 recruiting
  • Malmö University

    Malmö, Skåne County, 205 06

    Rikard Roxner, MScDSc, +46 40 665 84 80, rikard.roxnmer@gmail.com

    Recruiting

Other trials in Sweden

About this study

Official title: Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental

This is a qualitative interview study, using Grounded Theory. The aim is to deepen our knowledge about how the dental team (dentists, dental hygienists, and dental assistants) and dental students perceive child patients' pain and how they perceive they are equipped to prevent and deal with child patients' pain and the child's response to pain during and after dental treatment.

Read the detailed description

BACKGROUND Pain in conjunction with dental treatment should be avoided, especially when treating children. Many dental procedures may result in procedural and/or postoperative pain. There is a well-documented relationship between perceived pain during dental treatment, and the development of dental fear and anxiety. This may lead to suffering for the patient, avoidance of dental care, and increasing treatment costs for the individual and society. Dental care professionals are responsible for providing as painless dental treatments as possible to their child patients. Earlier studies have pointed towards an underusage of local anesthetics when providing dental care to children. Though previous studies have not been able to fully answer why this is. Thus, the aim of this study is to gain knowledge into how dental professionals and students experience and relate to the child patient's experience of pain during and after dental treatment.

METHOD This is a qualitative study using Grounded Theory (GT). Dental students in their last two years of education and dental professionals (dentists, dental hygienists, and dental assistants), will be consecutively enrolled after signing an informed consent form.

In-depth interviews of approximately one hour each will be performed with the informants at a place of their convenience. Appropriate measures will be taken regarding public health recommendations in effect due to the Covid-19 pandemic.

In GT no sample size calculation is done. Participants will be included until saturation in data is reached, i.e. no new information can be obtained from further interviews. In GT this is often achieved after 10-15 interviews, but due to the scope of this study involving several different professionals and students it is likely the number of informants will be closer to 25. All interviews will be tape recorded, and without delay, the interviews will be transcribed verbatim. Data analyses and data collection will be done in tandem. The transcribed interviews will be analyzed, and codes identified. These codes will then be merged into different preliminary categories. In the following axial coding process, each category will be further developed by identifying common dimensions and characteristics (subcategories). Relations between data and categories is sought, and hereby a new whole is created. Selective coding will lead to data saturation and validation. Saturation can also be achieved by already retrieved data being re-coded.

KNOWLEDGE GAINS GT is a theory generating method. This is especially suitable for research areas where theories are scarce or lacking. A lot of research within the medical and dental field today, takes the perspective of the investigator, and far too seldom is the subjective experience of those directly affected (e.g. professionals and/or patients) heard. From this study we will gain new knowledge into dental professionals' and students' perception of the child patients' experiences of procedural and postoperative pain. These knowledge gains will be important for future research strategies related to pain. In the longer run the results can help lead to a better training of undergraduate students and professionals.

CHANGES TO ORIGINAL STUDY PLAN After the initial interviews were made, we saw that dental students had a pedagogical focus in their interviews. Therefore, we decided to split informants into two groups - dental students and dental professionals. Findings will be presented in two separate scientific papers, one for each group of participants. Interviews with dental students have been completed, while interviews with dental professionals are ongoing.

Conditions
Pain
Being tested
Interview
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterviewBehavioural

    Interview study using Grounded theory, to investigate dental professionals' and students' perception of child patient's experience and need for treatment regarding procedural and postoperative pain.

Study groups in NCT04643951
Study groupRoleWhat they receive
Dental studentsDental students in their two final years. No intervention.
Receives: Behavioral: Interview
Dental professionalsDental professionals aged 18-65, regularly working with children. No intervention.
Receives: Behavioral: Interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain in pediatric dentistry, a Grounded theory study on the experiences of dental professionals and students.

    By means of in-depth interviews and data analysis according to Grounded Theory, investigate dental professionals' and dental students' perceptions of child patients' experiences of pain related to dental treatment.

    Measured: June, 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start1 Dec 2020
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Other
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04643951
Sponsor's protocol ID
FO 2020/529.
Status last verified
May 2025
First submitted
9 Nov 2020
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Berlin H, List T, Ridell K, Klingberg G. Dentists' attitudes towards acute pharmacological pain management in children and adolescents. Int J Paediatr Dent. 2018 Mar;28(2):152-160. doi: 10.1111/ipd.12316. Epub 2017 Jul 10.

    PubMed 28691744
  • Murtomaa H, Milgrom P, Weinstein P, Vuopio T. Dentists' perceptions and management of pain experienced by children during treatment: a survey of groups of dentists in the USA and Finland. Int J Paediatr Dent. 1996 Mar;6(1):25-30. doi: 10.1111/j.1365-263x.1996.tb00204.x.

    PubMed 8695586
  • Rasmussen JK, Frederiksen JA, Hallonsten AL, Poulsen S. Danish dentists' knowledge, attitudes and management of procedural dental pain in children: association with demographic characteristics, structural factors, perceived stress during the administration of local analgesia and their tolerance towards pain. Int J Paediatr Dent. 2005 May;15(3):159-68. doi: 10.1111/j.1365-263X.2005.00635.x.

    PubMed 15854111
  • Charmaz, K. Grounded theory. In: Smith, J.A., Harre, R. & van Langenhove, L. (eds.) Rethinking methods in psychology. 2nd ed. London: Sage Publications, 1995; 27-49.

  • Glaser, B. & Strauss, A. The discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter, 1967.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, 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 2 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: looking for participants now, as of the sponsor's last update on 18 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?

Contact Rikard Roxner, DDS (+46 40 665 84 80, rikard.roxner@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain in pediatric dentistry, a Grounded theory study on the experiences of dental professionals and students. (time frame: June, 2021). 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 NCT04643951, which also lists 5 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 18 May 2025.

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