NCT03293342

Brief Summary

The study is an RCT study comparing a 3-5 intervention treatment with dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a "treatment as usual" concept using premedication with benzodiazepines and a common sense approach. The treatment will be performed in a regular dental office. The dentist is working as a regular dentist and is trained in the CBT Method.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 10, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

3.1 years

First QC Date

September 14, 2017

Last Update Submit

November 2, 2020

Conditions

Dental Fear

Outcome Measures

Primary Outcomes (1)

  • Level of Dental anxiety, Dental Anxiety Scale ( MDAS)

    MDAS is a 5 item scale measuring dental anxiety in a range from 5-25. Outcome measure: change in MDAS

    At baseline, after 3-5 weeks of treatment, after 1 year and after 5 years

Study Arms (2)

D CBT

EXPERIMENTAL

Dentist administered cognitive behaviioral treatment

Behavioral: D CBT

Control

ACTIVE COMPARATOR

Treatment as usual

Combination Product: Control

Interventions

D CBTBEHAVIORAL

Intervention: a 3-5 session treatment of dental fear. * Psychoeducation about anxiety * Exploration of the individual anxiety * Exposure to the frightening stimuli (no hiding, but actively showing in detail all components of dental treatment, preferably utilizing a mirror while doing treatment).

D CBT
ControlCOMBINATION_PRODUCT

Intervention: Traditional treatment of dental fear common sense/ benzodiazepine

Control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Strong dental anxiety that affects the patients self-perceived ability to go through dental treatment
  • Age over 18
  • Agreement to all the practical arrangements of the study

You may not qualify if:

  • Substance abuse
  • Not being able to communicate fluently in Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0317, Norway

Location

Related Publications (22)

  • Hagglin C, Hakeberg M, Ahlqwist M, Sullivan M, Berggren U. Factors associated with dental anxiety and attendance in middle-aged and elderly women. Community Dent Oral Epidemiol. 2000 Dec;28(6):451-60. doi: 10.1034/j.1600-0528.2000.028006451.x.

    PMID: 11106018BACKGROUND

  • Hakeberg M, Berggren U, Carlsson SG, Grondahl HG. Long-term effects on dental care behavior and dental health after treatments for dental fear. Anesth Prog. 1993;40(3):72-7.

    PMID: 7645792BACKGROUND

  • Hakeberg M, Berggren U. Changes in sick leave among Swedish dental patients after treatment for dental fear. Community Dent Health. 1993 Mar;10(1):23-9.

    PMID: 8495390BACKGROUND

  • Schuller AA, Willumsen T, Holst D. Are there differences in oral health and oral health behavior between individuals with high and low dental fear? Community Dent Oral Epidemiol. 2003 Apr;31(2):116-21. doi: 10.1034/j.1600-0528.2003.00026.x.

    PMID: 12641592BACKGROUND

  • Armfield JM, Heaton LJ. Management of fear and anxiety in the dental clinic: a review. Aust Dent J. 2013 Dec;58(4):390-407; quiz 531. doi: 10.1111/adj.12118.

    PMID: 24320894BACKGROUND

  • Davies JG, Wilson KI, Clements AL. A joint approach to treating dental phobia: a re-evaluation of a collaboration between community dental services and specialist psychotherapy services ten years on. Br Dent J. 2011 Aug 26;211(4):159-62. doi: 10.1038/sj.bdj.2011.674.

    PMID: 21869789BACKGROUND

  • Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.

    PMID: 23746494BACKGROUND

  • Vika M, Skaret E, Raadal M, Ost LG, Kvale G. One- vs. five-session treatment of intra-oral injection phobia: a randomized clinical study. Eur J Oral Sci. 2009 Jun;117(3):279-85. doi: 10.1111/j.1600-0722.2009.00628.x.

    PMID: 19583756BACKGROUND

  • Willumsen T, Vassend O. Effects of cognitive therapy, applied relaxation and nitrous oxide sedation. A five-year follow-up study of patients treated for dental fear. Acta Odontol Scand. 2003 Apr;61(2):93-9. doi: 10.1080/00016350310001442.

    PMID: 12790506BACKGROUND

  • Brahm CO, Lundgren J, Carlsson SG, Nilsson P, Hultqvist J, Hagglin C. Dentists' skills with fearful patients: education and treatment. Eur J Oral Sci. 2013 Jun;121(3 Pt 2):283-91. doi: 10.1111/eos.12017. Epub 2013 Jan 19.

    PMID: 23659263BACKGROUND

  • Strom K, Ronneberg A, Skaare AB, Espelid I, Willumsen T. Dentists' use of behavioural management techniques and their attitudes towards treating paediatric patients with dental anxiety. Eur Arch Paediatr Dent. 2015 Aug;16(4):349-55. doi: 10.1007/s40368-014-0169-1. Epub 2015 Mar 10.

    PMID: 25753025BACKGROUND

  • Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.

    PMID: 7584581BACKGROUND

  • Armfield JM. Development and psychometric evaluation of the Index of Dental Anxiety and Fear (IDAF-4C+). Psychol Assess. 2010 Jun;22(2):279-87. doi: 10.1037/a0018678.

    PMID: 20528055BACKGROUND

  • Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

    PMID: 26606250BACKGROUND

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND

  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PMID: 16367493BACKGROUND

  • Astrom AN, Haugejorden O, Skaret E, Trovik TA, Klock KS. Oral Impacts on Daily Performance in Norwegian adults: validity, reliability and prevalence estimates. Eur J Oral Sci. 2005 Aug;113(4):289-96. doi: 10.1111/j.1600-0722.2005.00225.x.

    PMID: 16048520BACKGROUND

  • Haugejorden O, Klock KS, Astrom AN, Skaret E, Trovik TA. Socio-economic inequality in the self-reported number of natural teeth among Norwegian adults--an analytical study. Community Dent Oral Epidemiol. 2008 Jun;36(3):269-78. doi: 10.1111/j.1600-0528.2007.00367.x.

    PMID: 18474059BACKGROUND

  • Bernson JM, Elfstrom ML, Hakeberg M. Adaptive coping strategies among adults with dental fear. Further development of a new version of the Dental Coping Strategy Questionnaire. Acta Odontol Scand. 2012 Sep;70(5):414-20. doi: 10.3109/00016357.2011.634830. Epub 2011 Nov 30.

    PMID: 22126426BACKGROUND

  • Goldberg LR. The structure of phenotypic personality traits. Am Psychol. 1993 Jan;48(1):26-34. doi: 10.1037//0003-066x.48.1.26.

    PMID: 8427480BACKGROUND

  • Hauge MS, Willumsen T, Stora B. Changes in symptoms of anxiety, depression, and PTSD in an RCT-study of dentist-administered treatment of dental anxiety. BMC Oral Health. 2023 Jun 22;23(1):415. doi: 10.1186/s12903-023-03061-4.

    PMID: 37349747DERIVED

  • Hauge MS, Stora B, Vassend O, Hoffart A, Willumsen T. Dentist-administered cognitive behavioural therapy versus four habits/midazolam: An RCT study of dental anxiety treatment in primary dental care. Eur J Oral Sci. 2021 Aug;129(4):e12794. doi: 10.1111/eos.12794. Epub 2021 May 7.

    PMID: 33960536DERIVED

Study Officials

  • Professor Willumsen, PdD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Each patient receives a project number. A codebook between project number and journal number is stored at Tannhelsetjenestens kompetansesenter sør in Arendal. All data will be registered online using Nettskjema to collect data directly into Services for sensitive data (TSD). The research data from each patient will only be identified by the project number. All data will be stored and analysed using the TSD platform. TSD complies with the directive of privacy and electronic communication in Norway. TSD is developed and operated by USIT, the UiO centre for IT.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 26, 2017

Study Start

September 10, 2017

Primary Completion

November 2, 2020

Study Completion

December 20, 2022

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)