PainNCT03689517
Placebo Modulation of Orthodontic Pain
A study testing orthodontic elastic separators in people with Pain, run by West China Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- orthodontic elastic separators
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2014to 7 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting
- discomfort during the scan process or during menstruation.
About this study
Official title: Placebo Modulation of Orthodontic Pain: a Single-blind Functional MRI Study
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.
Read the 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
- Being tested
- placebo, orthodontic elastic separators
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
participants took placebos (pills made by starch) that were told to be an effective analgesic.
orthodontic elastic separatorsDevice
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: orthodontic elastic separators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start7 Aug 2014
- Primary completion8 Jul 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiya Gao, West China Hospital
- Investigators
- Wenli Lai, Prof, Study director, West China Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689517
- Sponsor's protocol ID
- WCHSIRB-D-2014-048
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Modulation of Orthodontic Pain: a Single-blind Functional MRI Study
- ClinicalTrials.gov ID
- NCT03689517
- Acronym / sponsor ID
- WCHSIRB-D-2014-048
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 7 Aug 2014 (actual)
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo arm | Experimental | Other: placebo, Device: orthodontic elastic separatorsOrthodontic 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 |
| sham arm | Sham comparator | Device: orthodontic elastic separatorsOrthodontic 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 |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting
- discomfort during the scan process or during menstruation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboparticipants took placebos (pills made by starch) that were told to be an effective analgesic. | Other | placebo arm |
| orthodontic elastic separatorsOrthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar. | Device | placebo arm, sham arm |
Primary outcome
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.
1 secondary outcome
The chronological changes of anxiety level
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenli Lai, Prof study director
West China Hospital of Stomatology
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic elastic separators in people with Pain, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI data change during MRI scan (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.