Placebo Modulation of Orthodontic Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689517
• Other study ID #: WCHSIRB-D-2014-048
• Status: Completed
• Phase: N/A
• Start date: August 7, 2014
• Est. completion date: December 7, 2016

Study information

• Verified date: September 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 7, 2016
• Est. primary completion date: July 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI data change during MRI scan	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.	Day 1
Secondary	The chronological changes of anxiety level	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.	Day 1