Placebo Modulation of Orthodontic Pain

NCT ID: NCT03689517

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-07
• Study Completion Date: 2016-12-07

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.

Conditions

Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

placebo

Intervention Type: OTHER

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

orthodontic elastic separators

Intervention Type: DEVICE

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

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

Group Type: SHAM_COMPARATOR

orthodontic elastic separators

Intervention Type: DEVICE

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

Interventions

placebo

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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meiya Gao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenli Lai, Prof

Role: STUDY_DIRECTOR

West China hospital of stomatology

Other Identifiers

WCHSIRB-D-2014-048

Identifier Type: -

Identifier Source: org_study_id