Dental MalocclusionNCT05615688
Pain and Activity Levels After Orthodontic Separators
A study testing Pain Intensity following Placement of Orthodontic Separators in people with Dental Malocclusion, run by Lina Sharab at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 15-49 in relation to their recorded physical activity level. Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- Pain Intensity following Placement of Orthodontic Separators
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 30 Sep 2025
- 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 15 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Student, resident, or staff at the University of Kentucky
- Aged 15-49 at time of enrollment in the study
- Erupted permanent first and second molars with interproximal contacts
- Presence of antagonist teeth in the opposite arch with no open bite
- Voluntary participation in study
- Access to a smartphone, tablet, or computer
- Valid email address
Who cannot join
- Any chronic pain condition (examples include trigeminal neuralgia, migraines, fibromyalgia, arthritis, neuropathies)
- Current use of pain medication (analgesics, opioids, nerve pain medications) for any condition
- Clinically evident interproximal decay in the site where separators will be placed
- Missing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retained
- If you do not have access to a computer, smartphone, or tablet with internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?
The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 15-49 in relation to their recorded physical activity level.
Hypothesis 1: The investigators hypothesize that participants with higher daily step counts and physical activity levels will report significantly less pain intensity from orthodontic separators than their less active peers following separator placement. Null hypothesis is that participants with higher daily step counts will report the same pain intensity from orthodontic separators than their less active peers following separator placement
Read more
The secondary aim is to describe the course of pain, at 24 hr intervals, over the next seven days following separator placement.
Hypothesis 2: The investigators hypothesize that more physically active participants will report ratings of zero pain intensity faster (sooner) than their less active peers throughout the one week study. Secondary null hypothesis is that more physically active participants will report ratings of zero pain intensity at the same rate as their less active peers throughout the one week study.
Read the detailed description
Acute pain or discomfort during orthodontic treatment is commonly reported. A study done in 2002 found that 87% of patients experienced pain after orthodontic visits. Additionally, "feeling pain" has been identified as the primary treatment concern for many patients prior to orthodontic treatment. More so, it can negatively affect patient compliance and attitude toward treatment.
Numerous studies have shown that pain varies in intensity and duration among orthodontic patients. The placement of orthodontic separators is a standard procedure to facilitate placement of orthodontic bands by creating a small amount of space between posterior teeth. Separator placement reliably produces acute discomfort to patients. Pain generated from orthodontic separator placement originates in the periodontal ligament (PDL) as compression forces are applied to the PDL unequally to open a small space (less than 0.5 mm) between the teeth. This compression triggers sterile necrosis or hyalinization in some areas of the PDL, leading to acute pain. The course of pain generated from orthodontic separators typically begins 4 hours after placement, reaching highest pain intensity approximately 24 hours after placement, and continuing to decrease in intensity until returning to pre-placement baseline after seven days.
Variation in reported pain intensity across orthodontic patients is of interest to any practitioner who desires to improve patient outcomes. In an attempt to enhance the orthodontist ability to understand pain and its predicting factors, researchers have examined pain from orthodontic treatment relative to patient demographics, personality traits, psychological factors, perceived need and attitude toward treatment, among others. Okeson asserts that pain is not directly related to the extent of tissue injury. Noxious stimuli originating in peripheral neurons (such is the case with separators) are subject to modulation at multiple levels through a complex central inhibitory system, where many other factors participate in decreasing or increasing the pain experience. Hence, an individual's emotional state, pain expectation and perception of control, as well as activities or distractions that will differ brain attention (Gate Control) can significantly influence the pain experience. Perceived stress, or the degree to which situations in an individual's life exceed their ability to cope, could be a good predictor of experienced pain. The Perceived Stress Scale is the most widely used screening form to evaluate perceived stress and asks subjects to recall the frequency of feeling overloaded and overwhelmed in the past month.
Recently, more attention has been given to the role of physical activity (PA) in reducing pain in patients that undergo orthodontic treatment. Physical activity has been shown to be an effective mediator of acute pain tolerance and pain sensitivity, an effect known as Exercise Induced Hypoalgesia (EIH). One study reported that a 1-mile run decreased pain intensity evoked from a weight being placed on the index finger. A similar decrease in pain response to pressure applied to the finger was found in subjects in another study who performed 30 minutes of aerobic exercise. It has also been demonstrated that exercise increased dental pain thresholds in response to electrical stimulation of the pulp. The exact mechanism involved in EIH remains elusive. Still, several pathways have been implicated including activation of the endogenous opioid pathway, increased Adrenocorticotropic Hormone release, and a conditioned pain the pain perceived in another area of the body.
Researchers have demonstrated that higher self-reported physical activity reduced the pain levels generated by placement of orthodontic separators when compared to patients with low physical activity. Self-reported measurements of physical activity carry limitations. The Physical Activity Questionnaire (PAQ) used in previous studies have demonstrated an only moderate correlation with direct activity observation (r=0.45), and with an activity monitoring device (r=0.57). The PAQ asks participants to report pain in the last seven days, and if given before treatment was performed, provides no data on physical activity during the week when subjects are experiencing pain. To further explore the correlation between physical activity and acute pain during orthodontic treatment, a more reliable measure of physical activity is warranted.
Actigraphy sensors provide an objective measure of physical activity. Actigraphy sensors include pedometers, which count steps over a defined time interval, and accelerometers, which measure acceleration in "activity counts" that are then extrapolated to the Metabolic Equivalent of Task (METS) to measure energy expenditure. No other paper has evaluated the effect of physical activity measured with pedometers on acute pain following separators placement during orthodontic treatment. Because not all patients experience pain at the same level, it would be beneficial for clinicians to identify which patients are likely to experience more intense pain before beginning treatment. To this end, the purpose of this study is to test the effect of physical activity measured by pedometer on acute pain produced by the placement of separators.
Protocol amended to include minors aged 15-17.
- Conditions
- Dental Malocclusion
- Being tested
- Pain Intensity following Placement of Orthodontic Separators
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Intensity following Placement of Orthodontic SeparatorsProcedure or surgery
Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Subjects will wear receive an activity monitor prior to placement of elastic separators and instructed to wear it 24/7 unless showering or swimming. Subjects will complete a recurrent Pain Scale Questionnaire 2-4 hrs after placement of elastics and every 24 hrs from day 2- 7.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic Separators Placed | Experimental | Elastomeric separators will be placed on the mesial and distal of the lower first permanent molars for a total of four separators per subject. Receives: Procedure: Pain Intensity following Placement of Orthodontic Separators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Subjects will be given an activity monitor to wear full time following the placement of the orthodontic spacers. They will report their level of pain to on a recurrent Pain Intensity questionnaire (using a Visual Analog Scale in REDCap) at 2-4 hrs after placement, and again at 24 hour intervals for the next 7 days following separator placement. The left of the digital Visual Analog Scale will be labeled "no pain" and the right will be labeled "worst pain imaginable". REDCap assigns a value of 0 on the left side of the scale and increased to100 on the right of the scale.
Measured: 7 days
Secondary outcomes (1)
Change in Proportion of patients reporting ZERO Pain over time
Subjects will be given an activity monitor to wear full time following the placement of the orthodontic spacers. They will report their level of pain on a recurrent Pain Intensity questionnaire (using a Visual Analog Scale in REDCap) at 2-4 hrs after placement, and again at 24 hour intervals for the next 7 days following separator placement. The left of the digital Visual Analog Scale will be labeled "no pain" and the right will be labeled "worst pain imaginable". REDCap assigns a value of 0 on the left side of the scale and increased to100 on the right of the scale.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start14 Jul 2022
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dental MalocclusionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Activity monitors will be provided and participants instructed to wear 24/7 unless showering or swimming to measure and collect level of physical activity Baseline data will be collected via questionnaires that include: Medical History, Demographics, and Perceived Stress Scale. Subjects will also complete a Recurrent Questionnaire at 2-4 hrs post placement and every evening for days 2-7 to report Pain Intensity using a Visual Analog Scale
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lina Sharab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lina Sharab, University of Kentucky
- Investigators
- Lina Sharab, DDS, MS, MSc, Principal investigator, Assistant Professor, Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615688
- Sponsor's protocol ID
- 55656
- Status last verified
- Oct 2025
- First submitted
- 19 Aug 2022
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x.
PubMed 12013568Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
PubMed 9844209Abu Alhaija ES, Aldaikki A, Al-Omairi MK, Al-Khateeb SN. The relationship between personality traits, pain perception and attitude toward orthodontic treatment. Angle Orthod. 2010 Nov;80(6):1141-9. doi: 10.2319/012710-59.1.
PubMed 20677967Beck VJ, Farella M, Chandler NP, Kieser JA, Thomson WM. Factors associated with pain induced by orthodontic separators. J Oral Rehabil. 2014 Apr;41(4):282-8. doi: 10.1111/joor.12144. Epub 2014 Feb 1.
PubMed 24483937Campos LA, Santos-Pinto A, Maroco J, Campos JADB. Pain perception in orthodontic patients: A model considering psychosocial and behavioural aspects. Orthod Craniofac Res. 2019 Aug;22(3):213-221. doi: 10.1111/ocr.12315. Epub 2019 May 15.
PubMed 31021044Rakhshan H, Rakhshan V. Pain and discomfort perceived during the initial stage of active fixed orthodontic treatment. Saudi Dent J. 2015 Apr;27(2):81-7. doi: 10.1016/j.sdentj.2014.11.002. Epub 2015 Jan 27.
PubMed 26082574Sandhu SS, Leckie G. Orthodontic pain trajectories in adolescents: Between-subject and within-subject variability in pain perception. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):491-500.e4. doi: 10.1016/j.ajodo.2015.10.020.
PubMed 27021453Sandhu SS, Sandhu J. Orthodontic pain: an interaction between age and sex in early and middle adolescence. Angle Orthod. 2013 Nov;83(6):966-72. doi: 10.2319/030113-174.1. Epub 2013 May 24.
PubMed 23705940Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
PubMed 2750720Bondemark L, Fredriksson K, Ilros S. Separation effect and perception of pain and discomfort from two types of orthodontic separators. World J Orthod. 2004 Summer;5(2):172-6.
PubMed 15615136
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?
- ClinicalTrials.gov ID
- NCT05615688
- Acronym / sponsor ID
- 55656
- Conditions
- Dental Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Lina SharabUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Nov 2022 (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.
The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 15-49 in relation to their recorded physical activity level.
Hypothesis 1: The investigators hypothesize that participants with higher daily step counts and physical activity levels will report significantly less pain intensity from orthodontic separators than their less active peers following separator placement. Null hypothesis is that participants with higher daily step counts will report the same pain intensity from orthodontic separators than their less active peers following separator placement
The secondary aim is to describe the course of pain, at 24 hr intervals, over the next seven days following separator placement.
Hypothesis 2: The investigators hypothesize that more physically active participants will report ratings of zero pain intensity faster (sooner) than their less active peers throughout the one week study. Secondary null hypothesis is that more physically active participants will report ratings of zero pain intensity at the same rate as their less active peers throughout the one week study.
Detailed description
Acute pain or discomfort during orthodontic treatment is commonly reported. A study done in 2002 found that 87% of patients experienced pain after orthodontic visits. Additionally, "feeling pain" has been identified as the primary treatment concern for many patients prior to orthodontic treatment. More so, it can negatively affect patient compliance and attitude toward treatment.
Numerous studies have shown that pain varies in intensity and duration among orthodontic patients. The placement of orthodontic separators is a standard procedure to facilitate placement of orthodontic bands by creating a small amount of space between posterior teeth. Separator placement reliably produces acute discomfort to patients. Pain generated from orthodontic separator placement originates in the periodontal ligament (PDL) as compression forces are applied to the PDL unequally to open a small space (less than 0.5 mm) between the teeth. This compression triggers sterile necrosis or hyalinization in some areas of the PDL, leading to acute pain. The course of pain generated from orthodontic separators typically begins 4 hours after placement, reaching highest pain intensity approximately 24 hours after placement, and continuing to decrease in intensity until returning to pre-placement baseline after seven days.
Variation in reported pain intensity across orthodontic patients is of interest to any practitioner who desires to improve patient outcomes. In an attempt to enhance the orthodontist ability to understand pain and its predicting factors, researchers have examined pain from orthodontic treatment relative to patient demographics, personality traits, psychological factors, perceived need and attitude toward treatment, among others. Okeson asserts that pain is not directly related to the extent of tissue injury. Noxious stimuli originating in peripheral neurons (such is the case with separators) are subject to modulation at multiple levels through a complex central inhibitory system, where many other factors participate in decreasing or increasing the pain experience. Hence, an individual's emotional state, pain expectation and perception of control, as well as activities or distractions that will differ brain attention (Gate Control) can significantly influence the pain experience. Perceived stress, or the degree to which situations in an individual's life exceed their ability to cope, could be a good predictor of experienced pain. The Perceived Stress Scale is the most widely used screening form to evaluate perceived stress and asks subjects to recall the frequency of feeling overloaded and overwhelmed in the past month.
Recently, more attention has been given to the role of physical activity (PA) in reducing pain in patients that undergo orthodontic treatment. Physical activity has been shown to be an effective mediator of acute pain tolerance and pain sensitivity, an effect known as Exercise Induced Hypoalgesia (EIH). One study reported that a 1-mile run decreased pain intensity evoked from a weight being placed on the index finger. A similar decrease in pain response to pressure applied to the finger was found in subjects in another study who performed 30 minutes of aerobic exercise. It has also been demonstrated that exercise increased dental pain thresholds in response to electrical stimulation of the pulp. The exact mechanism involved in EIH remains elusive. Still, several pathways have been implicated including activation of the endogenous opioid pathway, increased Adrenocorticotropic Hormone release, and a conditioned pain the pain perceived in another area of the body.
Researchers have demonstrated that higher self-reported physical activity reduced the pain levels generated by placement of orthodontic separators when compared to patients with low physical activity. Self-reported measurements of physical activity carry limitations. The Physical Activity Questionnaire (PAQ) used in previous studies have demonstrated an only moderate correlation with direct activity observation (r=0.45), and with an activity monitoring device (r=0.57). The PAQ asks participants to report pain in the last seven days, and if given before treatment was performed, provides no data on physical activity during the week when subjects are experiencing pain. To further explore the correlation between physical activity and acute pain during orthodontic treatment, a more reliable measure of physical activity is warranted.
Actigraphy sensors provide an objective measure of physical activity. Actigraphy sensors include pedometers, which count steps over a defined time interval, and accelerometers, which measure acceleration in "activity counts" that are then extrapolated to the Metabolic Equivalent of Task (METS) to measure energy expenditure. No other paper has evaluated the effect of physical activity measured with pedometers on acute pain following separators placement during orthodontic treatment. Because not all patients experience pain at the same level, it would be beneficial for clinicians to identify which patients are likely to experience more intense pain before beginning treatment. To this end, the purpose of this study is to test the effect of physical activity measured by pedometer on acute pain produced by the placement of separators.
Protocol amended to include minors aged 15-17.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Activity monitors will be provided and participants instructed to wear 24/7 unless showering or swimming to measure and collect level of physical activity Baseline data will be collected via questionnaires that include: Medical History, Demographics, and Perceived Stress Scale. Subjects will also complete a Recurrent Questionnaire at 2-4 hrs post placement and every evening for days 2-7 to report Pain Intensity using a Visual Analog Scale
| Arm | Type | Receives |
|---|---|---|
| Orthodontic Separators Placed | Experimental | Procedure: Pain Intensity following Placement of Orthodontic SeparatorsElastomeric separators will be placed on the mesial and distal of the lower first permanent molars for a total of four separators per subject. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Student, resident, or staff at the University of Kentucky
- Aged 15-49 at time of enrollment in the study
- Erupted permanent first and second molars with interproximal contacts
- Presence of antagonist teeth in the opposite arch with no open bite
- Voluntary participation in study
Key exclusion criteria (5 listed)
- Any chronic pain condition (examples include trigeminal neuralgia, migraines, fibromyalgia, arthritis, neuropathies)
- Current use of pain medication (analgesics, opioids, nerve pain medications) for any condition
- Clinically evident interproximal decay in the site where separators will be placed
- Missing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retained
- If you do not have access to a computer, smartphone, or tablet with internet access
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 |
|---|---|---|
| Pain Intensity following Placement of Orthodontic SeparatorsElastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Subjects will wear receive an activity monitor prior to placement of elastic separators and instructed to wear it 24/7 unless showering or swimming. Subjects will complete a recurrent Pain Scale Questionnaire 2-4 hrs after placement of elastics and every 24 hrs from day 2- 7. | Procedure or surgery | Orthodontic Separators Placed |
Primary outcome
Change in Pain Intensity
Time frame: 7 days
Subjects will be given an activity monitor to wear full time following the placement of the orthodontic spacers. They will report their level of pain to on a recurrent Pain Intensity questionnaire (using a Visual Analog Scale in REDCap) at 2-4 hrs after placement, and again at 24 hour intervals for the next 7 days following separator placement. The left of the digital Visual Analog Scale will be labeled "no pain" and the right will be labeled "worst pain imaginable". REDCap assigns a value of 0 on the left side of the scale and increased to100 on the right of the scale.
1 secondary outcome
Change in Proportion of patients reporting ZERO Pain over time
Time frame: 7 days
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 16 Oct 2025.
- Background: PubMed 12013568Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x.
- Background: PubMed 9844209Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
- Background: PubMed 20677967Abu Alhaija ES, Aldaikki A, Al-Omairi MK, Al-Khateeb SN. The relationship between personality traits, pain perception and attitude toward orthodontic treatment. Angle Orthod. 2010 Nov;80(6):1141-9. doi: 10.2319/012710-59.1.
- Background: PubMed 24483937Beck VJ, Farella M, Chandler NP, Kieser JA, Thomson WM. Factors associated with pain induced by orthodontic separators. J Oral Rehabil. 2014 Apr;41(4):282-8. doi: 10.1111/joor.12144. Epub 2014 Feb 1.
- Background: PubMed 31021044Campos LA, Santos-Pinto A, Maroco J, Campos JADB. Pain perception in orthodontic patients: A model considering psychosocial and behavioural aspects. Orthod Craniofac Res. 2019 Aug;22(3):213-221. doi: 10.1111/ocr.12315. Epub 2019 May 15.
- Background: PubMed 26082574Rakhshan H, Rakhshan V. Pain and discomfort perceived during the initial stage of active fixed orthodontic treatment. Saudi Dent J. 2015 Apr;27(2):81-7. doi: 10.1016/j.sdentj.2014.11.002. Epub 2015 Jan 27.
- Background: PubMed 27021453Sandhu SS, Leckie G. Orthodontic pain trajectories in adolescents: Between-subject and within-subject variability in pain perception. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):491-500.e4. doi: 10.1016/j.ajodo.2015.10.020.
- Background: PubMed 23705940Sandhu SS, Sandhu J. Orthodontic pain: an interaction between age and sex in early and middle adolescence. Angle Orthod. 2013 Nov;83(6):966-72. doi: 10.2319/030113-174.1. Epub 2013 May 24.
- Background: PubMed 2750720Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
- Background: PubMed 15615136Bondemark L, Fredriksson K, Ilros S. Separation effect and perception of pain and discomfort from two types of orthodontic separators. World J Orthod. 2004 Summer;5(2):172-6.
- 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.
Lina Sharab, DDS, MS, MSc principal investigator
Assistant Professor, Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Intensity following Placement of Orthodontic Separators in people with Dental Malocclusion, run by Lina Sharab at 1 site in United States.
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 5 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in Pain Intensity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615688, which also lists 10 linked publications.
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 16 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.