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CompletedNCT02160028Updated Feb 14, 2017

Pain and Placebo Analgesia. Does Extended Information About Dental Procedures Reduce Pain Induced by Dental Treatment?

An interventional study of anesthetics and extended information before dental treatment and anesthetics and standard information before dental treatment in Anxiety and Odontophobia, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2017-02-14.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Sex
All
01

Study summary

Information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. In this study it will be investigated whether this finding translates to the dental clinic. It will be investigated whether information that suggested that minimal pain will be experienced during filling therapy, can reduce the pain associated with that procedure compared to a group that receives standard information. All patients will receive the same amount of anesthesia and similar procedures during filling therapy. It is predicted that extended information should reduce pain, and that the reduction in pain should be associated with a reduction in stress.

02

Conditions studied

  • Anxiety
  • Odontophobia

Keywords

  • Information
  • Pain
  • Stress
  • Fear
  • Placebo analgesia
03

In context

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients to be treated for dental caries
  • Patients should be able to read and communicate in Norwegian

Exclusion criteria

Exclusion Criteria:

  • Patients with life threatening diseases
  • Patients taking pain killers for other reasons on the day of treatment
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    Standard information

    This group is given anesthetics and standard information before dental treatment about the anesthetics.

    Other: anesthetics and standard information before dental treatment

  • Experimental
    Extended information

    This group is given anesthetics and extended information before dental treatment about the anesthetics.

    Other: anesthetics and extended information before dental treatment

Interventions

  • Otheranesthetics and extended information before dental treatment

    The extended information is a comprehensive explanation about what to expect of the treatment and the anesthetic method, phrased in positive words and opening up for questions after information is given.

  • Otheranesthetics and standard information before dental treatment

    The standard information is short and concise, telling in neutral words what to expect.

06

What researchers measure

Primary outcomes

  1. Reduction of pain

    Pain intensity and pain discomfort will be measured by a VAS (Visual Analog Scale). The patients will report their experience of these factors verbally, four times during the treatment session.

    Time frame: 1 hour

Secondary outcomes

  1. Reduction of stress

    Stress is also measured using the VAS, i.e. using the same method as for pain. Stress or sympathetic activation is measured by using scin conductance on fingers (V-Amp (Brain Products, Munich, Germany).

    Time frame: One hour

07

Study locations

1 site
  • Tannlegesenteret Madlagården, TSMG
    Hafrsfjord, 4090, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02160028
Lead sponsor
Norwegian University of Science and Technology
Collaborators
University of Bergen, Tannhelsetjenestens Kompetansesenter Vest, TK Vest, Tannlegesenteret Madlagården, TSMG
Responsible party
Sponsor
First posted
Jun 10, 2014
Start date
Aug 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Feb 14, 2017

Study contacts

Magne A Flaten, phd prof
study director · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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