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Placebo Modulation of Orthodontic Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03689517
Enrollment
23
Registered
2018-09-28
Start date
2014-08-07
Completion date
2016-12-07
Last updated
2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

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.

Interventions

OTHERplacebo

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

DEVICEorthodontic elastic separators

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
fMRI data change during MRI scanDay 1The 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

MeasureTime frameDescription
The chronological changes of anxiety levelDay 1Secondary 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026