Physical Activity Impact on Orthodontic Separator Pain for Dental Misalignment

Overseen By Lina Sharab, DDS, MS, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lina Sharab

Must not be taking: Analgesics, Opioids, Nerve pain

Disqualifiers: Chronic pain, Missing teeth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

94 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

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 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.

Research Team

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

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

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

Group I: Orthodontic Separators Placed Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pain experienced by orthodontic patients following elastomeric separator insertion: A cross-sectional study. Sultan, H., Pervez, H., Maqsood, S., et al.[2023]

In a study of 40 orthodontic patients, those with ceramic brackets reported higher pain intensity and longer duration of pain compared to those with metal brackets, particularly in the upper anterior region.

Pain levels peaked at 24 hours after bracket placement, with the ceramic group averaging a pain score of 4.44, while the metal group averaged 2.7, indicating that ceramic brackets may lead to a more uncomfortable experience during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Perception of Pain during Fixed Orthodontic Treatment with Metal and Ceramic Brackets. Sahoo, N.[2022]

Elastomeric orthodontic separators produced a greater mean separation (0.2327 mm) compared to Kesling separators (0.1903 mm) after two days, indicating they may be more effective for creating space between teeth.

While both types of separators caused discomfort, the majority of patients reported discomfort rather than pain, suggesting that the use of separators can be managed to improve treatment acceptability by minimizing their duration of placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Separation Effect and Perception of Pain and Discomfort from Kesling and Elastomeric Orthodontic Separators: An In Vivo Study. Kumar, BD., Chandra, S., Singh, RN., et al.[2022]

In a study of 150 adolescents undergoing orthodontic treatment, those with higher baseline physical activity levels reported significantly less pain and consumed fewer analgesics after separator placement compared to those with lower activity levels.

Specifically, the high-activity group experienced an average pain reduction of nearly 9 points on a 100-mm scale and had a 56% lower likelihood of taking pain medication, highlighting the potential benefits of physical activity on pain management during orthodontic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical activity level on orthodontic pain perception and analgesic consumption in adolescents. Sandhu, SS., Sandhu, J.[2015]

Low Level Laser Therapy (LLLT) effectively reduces orthodontic pain caused by elastomeric separators, as shown in a study involving 36 patients aged 12 to 26, with significant pain reduction observed at all assessment times compared to a placebo.

There was no significant difference in pain reduction between single and double irradiation of LLLT, indicating that a single treatment may be sufficient for managing pain in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial. Almallah, MM., Almahdi, WH., Hajeer, MY.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. Nepal pubmed.ncbi.nlm.nih.gov

Pain and Oral Health Related Quality of Life among Patients Undergoing Fixed Orthodontic Treatment: A Descriptive Cross-sectional Study. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluation of pain experienced by orthodontic patients following elastomeric separator insertion: A cross-sectional study. [2023]

4. India pubmed.ncbi.nlm.nih.gov

Comparison of the Perception of Pain during Fixed Orthodontic Treatment with Metal and Ceramic Brackets. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Separation Effect and Perception of Pain and Discomfort from Kesling and Elastomeric Orthodontic Separators: An In Vivo Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of physical activity level on orthodontic pain perception and analgesic consumption in adolescents. [2015]

7. India pubmed.ncbi.nlm.nih.gov

Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial. [2022]