Physical Activity Impact on Orthodontic Separator Pain for Dental Misalignment

Overseen By Lina Sharab, DDS, MS, MSc

Age: < 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how physical activity affects pain levels caused by orthodontic separators, small devices placed between teeth to create space. The researchers aim to determine if more active individuals experience less pain than less active individuals after receiving these separators. The trial also monitors pain changes over a week. Suitable participants are healthy volunteers aged 15-49 from the University of Kentucky community with fully grown molars and no ongoing pain issues. As an unphased trial, this study allows participants to contribute to valuable research that could enhance pain management strategies for orthodontic treatments.

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.

What prior data suggests that the placement of orthodontic separators is safe?

Research has shown that orthodontic separators are generally safe and well-tolerated. These small devices create space between teeth before braces are applied. Studies have found that separators can cause some discomfort, but the level and duration of pain vary. Most people experience only mild pain that begins a few hours after placement.

One study compared different types of separators and found that Kesling separators often cause less discomfort than elastomeric separators. However, even elastomeric separators, which might cause slightly more discomfort, remain safe.

Overall, orthodontic separators are a common part of dental treatment with a well-established safety record. Any discomfort is usually manageable and temporary, often improving within a few days. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the impact of physical activity on orthodontic separator pain for dental misalignment because it introduces a holistic approach to pain management. Unlike standard treatments that typically involve analgesics or pain relievers, this approach examines how an increase in physical activity might naturally alleviate discomfort caused by the separators. This method could lead to a non-pharmacological option for managing orthodontic pain, which is appealing for those seeking to avoid medication and its potential side effects.

What evidence suggests that physical activity level monitoring is effective for reducing pain from orthodontic separators?

Studies have shown that different types of orthodontic separators cause varying levels of pain. This trial will use elastomeric separators, which usually cause moderate discomfort. In contrast, Kesling separators tend to cause less pain. Research suggests that the type of separator affects pain levels, but physical activity might also play a role. The study aims to explore whether more physically active individuals experience less pain from these separators. Exercise can increase endorphins, which are natural pain relievers. ^{3 6 7 8 9}

Who Is on the Research Team?

Lina Sharab, DDS, MS, MSc

Principal Investigator

Assistant Professor, Orthodontics

Are You a Good Fit for This Trial?

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.

Student, resident, or staff at the University of Kentucky

Presence of antagonist teeth in the opposite arch with no open bite

Exclusion Criteria

I am currently taking pain medication.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6526766/

Separation and pain perception of Elastomeric, Kesling ... Kesling separators produce adequate separation with minimal discomfort and pain, compared to Elastomeric and Kansal separators.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10547595/

Evaluation of pain experienced by orthodontic patients ... This study aimed to evaluate the characteristics of pain in orthodontic patients after the insertion of elastomeric separators, its effects on daily life,

3. thejcdp.com thejcdp.com/doi/10.5005/jp-journals-10024-3291

Separation Effect and Perception of Pain and Discomfort ... Aim: To scrutinize Kesling and elastomeric orthodontic separators, focusing on the separating effect as well as patients' perception of pain.

4. ajohas.com ajohas.com/split-mouth-clinical-trial-evaluating-pain-perception-in-orthodontic-patients-using-four-types-of-separators-an-in-vivo-study/

Split-mouth clinical trial evaluating pain perception in ... In this study, kansal separators produced the highest pain levels across all time points, while kesling separators were the most comfortable.

5. ijodr.com ijodr.com/archive/volume/5/issue/4/article/4782

A comparative study of separation effect of four different ... Result: Result of the study showed that dumbbell separator was most efficient in separating the teeth followed by elastomeric separator. Dumbbell separator was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6111192/

Comparison of two analgesics used for pain relief after ... The pain mechanism is associated with the placement of orthodontic separators that create space mesially and distally to teeth by a process related to changes ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05615688?tab=table

Pain and Activity Levels After Orthodontic Separators Numerous studies have shown that pain varies in intensity and duration among orthodontic patients. The placement of orthodontic separators is a standard ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07119814

Comparison of Outcome of Safe T Separators and ... Safe T separators and conventional elastomeric separators will be placed in patients of fixed orthodontic treatment. Device : Safe T separator.

9. researchgate.net researchgate.net/publication/311631083_Separators_in_Orthodontics_A_Review

(PDF) Separators in Orthodontics: A Review Results showed that pain began a few hours after application of ... Conclusion: Safe-T separators separate teeth optimally with minimal injury ...