NCT02919241

Brief Summary

Clinical trial of an application of cognitive behavioural one-session therapy method with patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst \& Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from three different places,primary care clinic, community dental care and dentist´s teaching clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

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

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

4.4 years

First QC Date

September 23, 2016

Last Update Submit

November 10, 2021

Conditions

Keywords

dental anxietycognitive therapy

Outcome Measures

Primary Outcomes (1)

  • Change in dental fear

    Change in fear is measured by a questionnaire called Modified Dental Anxiety Scale (MDAS). Change in fear is indicated by change in mean value of the MDAS between baseline and follow-up measurement

    6 months

Secondary Outcomes (1)

  • Compliance to care

    6 months

Study Arms (2)

Diagnostic interview

EXPERIMENTAL

Intervention for this group include diagnostic interview. Oral health Impact Profile (OHIP 14) and Spielberg State and Trait Anxiety (STAI-1) questionnaires and behaviour analyses are used in diagnostic interview.

Behavioral: Diagnostic interview

Combined interview and treatment

EXPERIMENTAL

Intervention for this group include both the diagnostic interview and one session treatment.

Behavioral: Diagnostic interviewBehavioral: Combined interview and treatment.

Interventions

A profound interview to declare causes for negative thoughts, assumptions and beliefs towards dental care. Participants come from public and Private dental care.

Combined interview and treatmentDiagnostic interview

Intervention for this group include both the diagnostic interview to declare causes for negative thoughts, assumptions and beliefs towards dental care and one session treatment. Participants come from the Institute of Dentistry.

Combined interview and treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MDAS 13 or over, dental care in normal circumstances doesn´t work, motivation to treat dental fear, minimum 18 year

You may not qualify if:

  • Mental disorder, dementia, pregnancy, acute state of somatic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

Location

Related Publications (1)

  • Kurki P, Korhonen M, Honkalampi K, Suominen AL. Patients' multifaceted views of dental fear in a diagnostic interview. Acta Odontol Scand. 2021 Apr;79(3):194-204. doi: 10.1080/00016357.2020.1817545. Epub 2020 Sep 12.

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Liisa Suominen, Professor

    University of easthern Finland, Kuopio

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 29, 2016

Study Start

August 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

It has been planned to use same data later in a follow-up study

Locations