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Completed

NCT Number: NCT03689517

Placebo Modulation of Orthodontic Pain

How placebo modulates orthodontic pain remains largely unknown. The present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fMRI.

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Key information

Age range

20 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

How placebo modulates orthodontic pain remains largely unknown. The present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fMRI. 23 voluneers were recruited in a longitudinal fMRI experiment. At both the baseline and the one-month follow-up, orthodontic separators were placed between right lower molars 24 hours before MRI scans. At baseline, the subjects were scanned without placebo while all subjects took placebos half an hour before the scan at follow-up. Scans include a bite/non-bite task fMRI and a followed resting state fMRI. A generalized linear model was used to identify pain-regulating network from task fMRI, and functional connectivity analysis of pain related brain regions was performed to study the possible modulation of placebo on connectivity of pain-regulating networks using resting-state fMRI.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female, 20-25 years old;
  • Right handed;
  • Understand the Visual Analog Scale;
  • No history of serious illness, surgery, psychiatric disorders or neurological;
  • No history of drug or alcohol abuse;
  • No Maxillofacial diseases, agomphiasis, caries, metal filling material or crown;
  • Individual normal occlusion with no orthodontic treatment history.

Exclusion criteria

  • claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting
  • discomfort during the scan process or during menstruation.

Treatment and study plan

Placebo

Other

participants took placebos (pills made by starch) that were told to be an effective analgesic.

orthodontic elastic separators

Device

Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar.

Primary outcomes

  1. fMRI data change during MRI scan

    Time frame: Day 1

    The fMRI data were collected with a Siemens 3.0T MRI system at West China Hospital. Scans include a bite/non-bite task fMRI and a followed resting state fMRI. Through MRI data we can investigate the modulation of brain activity associated with orthodontic pain using fMRI.

Secondary outcomes

  1. The chronological changes of anxiety level

    Time frame: Day 1

    Secondary outcomes concerning chronological changes of anxiety were assessed before and after orthodontic treatments through state-trait anxiety inventory (ST-AI). A higher score indicates higher anxiety level.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Placebo Modulation of Orthodontic Pain: a Single-blind Functional MRI Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2018
Registry last updated
Sep 28, 2018

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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