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Placebo Modulation of Orthodontic Pain

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ClinicalTrials.gov Identifier: NCT03689517
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Meiya Gao, West China Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Other: placebo Device: orthodontic elastic separators Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Placebo Modulation of Orthodontic Pain: a Single-blind Functional MRI Study
Actual Study Start Date : August 7, 2014
Actual Primary Completion Date : July 8, 2016
Actual Study Completion Date : December 7, 2016

Arm Intervention/treatment
Experimental: placebo arm
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
Other: placebo
participants took placebos (pills made by starch) that were told to be an effective analgesic.

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

Sham Comparator: sham arm
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
Device: orthodontic elastic separators
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689517


Sponsors and Collaborators
West China Hospital
Investigators
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Study Director: Wenli Lai, Prof West China hospital of stomatology
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Responsible Party: Meiya Gao, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT03689517    
Other Study ID Numbers: WCHSIRB-D-2014-048
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No