Placebo Modulation of Orthodontic Pain

NCT03689517 | Completed

• 1 other identifier: WCHSIRB-D-2014-048
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The chronological changes of anxiety level

  Day 1

Study Arms (2)

placebo arm

EXPERIMENTAL

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; Device: orthodontic elastic separators

sham arm

SHAM COMPARATOR

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

Interventions

placebo OTHER

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

placebo arm

orthodontic elastic separators DEVICE

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

placebo arm; sham arm

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting
• discomfort during the scan process or during menstruation.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenli Lai, Prof

  West China hospital of stomatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Study Start: August 7, 2014
• Primary Completion: July 8, 2016
• Study Completion: December 7, 2016
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share