Xylitol Gum for Orthodontic Braces Pain

Overseen By Karissa Spokane

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: West Virginia University

Disqualifiers: Pregnant, Breastfeeding

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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 explores whether chewing xylitol gum can reduce pain for children receiving braces. The goal is to determine if gum can make the braces experience more comfortable. Participants will either chew xylitol gum or refrain from chewing gum to compare the effects. Children who are getting braces and can chew gum may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on chewing gum for orthodontic pain, so it's unlikely that your medications will be affected, but you should confirm with the trial organizers.

Is there any evidence suggesting that xylitol gum is likely to be safe for humans?

Research has shown that xylitol gum is generally safe and can help reduce pain from braces. Studies have found that chewing gum significantly eases the discomfort caused by braces and serves as an affordable, safe option. Although the gum itself is safe, some types might harm braces by loosening brackets or bending wires. However, sugar-free gum with xylitol is recommended because it doesn't cause cavities. Many people find this type of gum helps relieve jaw pain from braces and is easy to tolerate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for orthodontic pain?

Unlike the standard options for managing orthodontic braces pain, which often include painkillers like ibuprofen, xylitol gum offers a more natural alternative. Xylitol, a sugar alcohol, not only provides pain relief but also promotes oral health by reducing cavity-causing bacteria. Chewing xylitol gum is a simple and convenient way to potentially manage discomfort, making it an exciting option for those looking for a non-pharmaceutical approach. Researchers are enthusiastic about its dual benefits for pain relief and oral hygiene, which could set it apart from existing treatments.

What evidence suggests that xylitol gum might be an effective treatment for orthodontic braces pain?

This trial will compare the effects of chewing xylitol gum with not chewing gum on pain from braces. Studies have shown that chewing xylitol gum can significantly reduce pain from braces. Specifically, research indicates that people who chewed xylitol gum felt less discomfort than those who did not. Xylitol gum increases saliva flow, soothing the gums and easing pain. Additionally, xylitol is safe for braces and does not cause any damage. Previous users found it effective in reducing pain without causing more dental problems. Overall, strong evidence suggests that xylitol gum can make wearing braces more comfortable by reducing pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Peter Ngan, DMD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for patients under 18 years old who are about to receive orthodontic braces. They must have consent from both themselves and their parents to participate. The study excludes anyone not meeting the age requirement or unable to follow the study protocol.

Inclusion Criteria

Participant and Parents able to sign and understand consent

Ability to chew gum

Exclusion Criteria

Pregnant or Breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthodontic appliances and are instructed to chew xylitol gum or refrain from chewing gum as part of the control group. Surveys are conducted at 4 hours, 24 hours, 48 hours, and 7 days post-treatment.

1 week

1 visit (in-person) for appliance placement, multiple surveys (virtual)

Follow-up

Participants are monitored for comfort levels and adherence to instructions post-treatment.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Xylitol Gum

Trial Overview

The trial tests if chewing xylitol gum can reduce pain from orthodontic treatment. It involves 60 young patients, half will chew xylitol gum three times a day after getting braces, while the other half won't chew any gum as a control group.

How Is the Trial Designed?

Group I: No Gum Active Control 1 Intervention

Control group that will refrain from chewing gum.

Group II: Xylitol Gum Active Control 1 Intervention

Chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10631172/

Effect of chewing gum on orthodontic pain in patients ...

Chewing gum is a non-invasive, low-cost and convenient method that has a significant effect on relieving orthodontic pain and has no effect on the rate of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07210697

Orthodontic Pain Alleviation With Chewing Gum

The aim of this study is to determine whether chewing gum can alleviate orthodontic treatment discomfort and improve orthodontic treatment ...

3.

researchgate.net

researchgate.net/publication/360266734_Effectiveness_of_Xylitol_Chewing_Gum_in_patients_with_Orthodontic_Pain

(PDF) Effectiveness of Xylitol Chewing Gum in patients with ...

CONCLUSION ; Hence in the aforementioned study, Xylitol gum had higher. analgesic efficacy than the control group without chewing gum in. the ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4605935/

Long-term clinical and bacterial effects of xylitol on patients ...

Our results demonstrated that xylitol chewing gum and chewable tablets had no negative effects on orthodontic appliances and did not increase ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003996922001807

Effect of chewing gum containing Xylitol and blackberry ...

Consistent with this, chewing xylitol-containing gum is effective in reducing dental caries development in high-risk children (Burt, 2006, Campus et al., 2013, ...

6.

omahadentists.net

omahadentists.net/blog/should-you-chew-gum-braces-tips-risks/

Should You Chew Gum With Braces Tips And Risks

Chewing gum with braces can be risky. Sticky or hard gum can damage brackets and wires, potentially lengthening your treatment and increasing costs. Gum stuck ...

7.

rallisbonilla.com

rallisbonilla.com/resources/can-you-chew-gum-with-braces/

Can You Chew Gum With Braces?

Risk of Damage – Chewing gum can lead to brackets coming loose or wires bending or breaking, necessitating unscheduled orthodontic adjustments ...

8.

iodentistry.com

iodentistry.com/is-chewing-gum-bad-for-your-teeth-insights-from-a-dentist-in-carrollton/

Is Chewing Gum Bad for Your Teeth?

Always choose sugar-free gum. The ADA recommends sugar-free gums that contain non-cavity-causing sweeteners like xylitol, sorbitol, or mannitol.

9.

blalockorthodontics.com

blalockorthodontics.com/can-you-chew-gum-with-braces-get-the-facts-from-dr-blalock/

Can you chew gum with braces? Get the facts from Dr. ...

Gum can help with pain.​​ Braces can be uncomfortable at times. Some people find that chewing gum helps ease the pain they feel in their jaws and ligaments.