Placebo Modulation of Orthodontic Pain

S

Sichuan University

Status

Completed

Conditions

Pain

Treatments

Other: placebo
Device: orthodontic elastic separators

Study type

Interventional

Funder types

Other

Identifiers

NCT03689517
WCHSIRB-D-2014-048

Details and patient eligibility

About

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.

Full description

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.

Enrollment

23 patients

Sex

Female

Ages

20 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

23 participants in 2 patient groups

placebo arm
Experimental group
Description:
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar. Participants took placebos (pills made by starch) that were told to be an effective analgesic
Treatment:
Device: orthodontic elastic separators
Other: placebo
sham arm
Sham Comparator group
Description:
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar. But participants do not take placebos
Treatment:
Device: orthodontic elastic separators

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems