94 Participants Needed

Physical Activity Impact on Orthodontic Separator Pain for Dental Misalignment

DG
LS
Overseen ByLina Sharab, DDS, MS, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you are not currently using any pain medications, such as analgesics, opioids, or nerve pain medications, for any condition.

Is the use of orthodontic separators and related devices generally safe for humans?

The research indicates that while orthodontic separators and related devices can cause pain and discomfort, there is no mention of serious safety concerns associated with their use in humans.12345

How does the treatment of orthodontic separators differ from other treatments for dental misalignment pain?

This treatment is unique because it explores the impact of physical activity on pain perception after placing orthodontic separators, which are small devices used to create space between teeth before braces. Unlike other treatments that might focus solely on pain relief through medication, this study considers how a person's level of physical activity might naturally influence their experience of pain.23567

What is the purpose of this trial?

The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 18-49 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 placementThe 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.

Research Team

LS

Lina Sharab, DDS, MS, MSc

Principal Investigator

Assistant Professor, Orthodontics

Eligibility Criteria

This trial is for University of Kentucky students, staff, or residents aged 18-49 with misaligned teeth who are not on pain medication and do not have chronic pain conditions. Participants must have a valid email, access to a smart device with internet, and certain dental criteria like erupted molars without decay.

Inclusion Criteria

My first and second permanent molars have fully come in and touch each other.
Presence of antagonist teeth in the opposite arch with no open bite
Voluntary participation in study
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Exclusion Criteria

I am currently taking pain medication.
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
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Placement of orthodontic separators and monitoring of pain intensity in relation to physical activity levels

1 week
1 visit (in-person) for separator placement

Follow-up

Participants report pain levels at 24-hour intervals for 7 days following separator placement

1 week
Daily self-reported pain assessments (virtual)

Treatment Details

Interventions

  • Physical Activity Level Monitoring
  • Placement of Orthodontic Separators
Trial Overview The study aims to assess the relationship between physical activity levels and the intensity of pain experienced after having orthodontic separators placed. It will compare reported pain in active individuals versus less active ones over seven days.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Orthodontic Separators PlacedExperimental Treatment1 Intervention
Elastomeric separators will be placed on the mesial and distal of the lower first permanent molars for a total of four separators per subject.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lina Sharab

Lead Sponsor

Trials
1
Recruited
90+

Findings from Research

In a study involving 42 orthodontic patients, customized plastic shields on brackets significantly reduced discomfort during the first 3 days of treatment, as measured by a visual analog scale (P = 0.04).
However, there was no significant difference in visible mucosal alterations between the shielded and non-shielded sides of the mouth, indicating that while the shields improved comfort, they did not prevent mucosal damage.
Can shielded brackets reduce mucosa alteration and increase comfort perception in orthodontic patients in the first 3 days of treatment? A single-blind randomized controlled trial.Pires, LP., de Oliveira, AH., da Silva, HF., et al.[2015]
In a study of 152 orthodontic patients, the average pain score during the first month of fixed orthodontic treatment was 5.05 out of 10, indicating that most patients (56.58%) experienced moderate pain.
The treatment significantly impacted patients' oral health-related quality of life, with 88.2% reporting painful aching in the mouth and 83.6% experiencing difficulty while eating, highlighting the need for orthodontists to prepare patients for potential discomfort.
Pain and Oral Health Related Quality of Life among Patients Undergoing Fixed Orthodontic Treatment: A Descriptive Cross-sectional Study.Poudel, P., Dahal, S., Thapa, VB.[2021]
In a study of 130 orthodontic patients, 63.8% reported experiencing pain after the insertion of elastomeric separators, with females reporting significantly more pain than males (P = 0.04).
Patients aged 21 to 36 years experienced more pain during chewing compared to those aged 9 to 20 years, indicating that age and sex are important factors in pain perception following orthodontic procedures.
Evaluation of pain experienced by orthodontic patients following elastomeric separator insertion: A cross-sectional study.Sultan, H., Pervez, H., Maqsood, S., et al.[2023]

References

Can shielded brackets reduce mucosa alteration and increase comfort perception in orthodontic patients in the first 3 days of treatment? A single-blind randomized controlled trial. [2015]
Pain and Oral Health Related Quality of Life among Patients Undergoing Fixed Orthodontic Treatment: A Descriptive Cross-sectional Study. [2021]
Evaluation of pain experienced by orthodontic patients following elastomeric separator insertion: A cross-sectional study. [2023]
Comparison of the Perception of Pain during Fixed Orthodontic Treatment with Metal and Ceramic Brackets. [2022]
Separation Effect and Perception of Pain and Discomfort from Kesling and Elastomeric Orthodontic Separators: An In Vivo Study. [2022]
Effect of physical activity level on orthodontic pain perception and analgesic consumption in adolescents. [2015]
Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial. [2022]
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