NCT04064853

Brief Summary

This is a qualitative study, using Grounded Theory. The aim is to deepen our knowledge about how children perceive pain in conjunction with dental treatment; tooth extractions in particular. What increases, and what decreases, the risk of children experiencing pain; and how do they perceive dental treatments where pain might occur, either as procedural pain, or postoperatively?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

August 20, 2019

Last Update Submit

March 14, 2023

Conditions

Keywords

grounded theorychildadolescentpostoperative painprocedural paintooth extraction

Outcome Measures

Primary Outcomes (1)

  • Children's experiences during and after tooth extraction, and it's consequences

    After tooth extraction, on orthodontic indications, participants, 10-15 years of age, are interviewed. The interviews are transcribed and analyzed, identifying codes, which will be clustered into categories. Through different types of methods, used in Grounded Theory, core categories will be identified which together with other categories and sub-categories, will answer the question "what is all this about?".

    Fall 2019

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 10-15 years of age, identified as eligable according to inclusion and exclusion criteria, during first visit to orthodontist, working in city of Malmö, Sweden.

You may qualify if:

  • Healthy individuals
  • In need of extraction of permanent premolars prior orthodontic treatment

You may not qualify if:

  • If sedation is needed to be able to comply with dental treatment
  • Do not understand Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odontology, Malmö University

Malmo, Skåne County, SE-20506, Sweden

Location

Related Publications (7)

  • Berlin H, List T, Ridell K, Davidson T, Toft D, Klingberg G. Postoperative pain profile in 10-15-year-olds after bilateral extraction of maxillary premolars. Eur Arch Paediatr Dent. 2019 Dec;20(6):545-555. doi: 10.1007/s40368-019-00425-9. Epub 2019 Apr 8.

    PMID: 30963511BACKGROUND
  • 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.

    PMID: 28691744BACKGROUND
  • Charmaz K. Grounded theory. In: Smith JA, Harre R, van Langenhove L, eds. Rethinking methods in psychology, 2nd ed. London: Sage Publications, 1995; 27-49.

    BACKGROUND
  • Charmaz K. Grounded theory. Objectivist and constructivist methods. In: Denzin NK, Lincoln YS, eds. Handbook of qualitative research, 2nd ed. Thousand Oaks, CA: Sage, 2000; 509-535.

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

    BACKGROUND
  • Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.

    PMID: 27501304BACKGROUND

MeSH Terms

Conditions

BehaviorPain, PostoperativePain, Procedural

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Henrik Berlin, DDS

    Malmö University, Faculty of Odontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, senior lecturer

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

April 5, 2019

Primary Completion

March 16, 2020

Study Completion

March 1, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared.

Locations