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Completed

NCT Number: NCT02160028

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Odontophobia Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tannlegesenteret Madlagården, TSMG

Hafrsfjord, 4090, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

anesthetics and extended information before dental treatment

Other

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.

anesthetics and standard information before dental treatment

Other

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

Primary outcomes

  1. Reduction of pain

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Reduction of stress

    Time frame: One hour

    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).

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Tannhelsetjenestens Kompetansesenter Vest, TK Vest
  • Tannlegesenteret Madlagården, TSMG
  • University of Bergen

Registry information

Official study title

Pain and Placebo Analgesia. A Double Blinded, Randomized, Clinical Study About the Impact of Information About Anesthesia, and the Experience of Pain and Stress During Dental Treatment.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2014
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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