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Orthodontic Pain Alleviation With Chewing Gum

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West Virginia University

Status and phase

Not yet enrolling
Phase 3

Conditions

Orthodontic Appliances

Treatments

Drug: Xylitol Gum

Study type

Interventional

Funder types

Other

Identifiers

NCT07210697
2506181765

Details and patient eligibility

About

The aim of this study is to determine whether chewing gum can alleviate orthodontic treatment discomfort and improve orthodontic treatment experience. The long-term goal is to enable clinicians to decide whether prescription of chewing gum at the placement of orthodontic appliances can improve patient experience with orthodontic treatment. In specific, a total of 60 patients under the age of 18 will be recruited for the study. Consent will be signed by both the child patient and the parents. 30 patients will be asked to chew xylitol gum and the other 30 patients will refrain from chewing gum and serve as the control group. At the appointment for insertion of orthodontic appliances, patients will be instructed to chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day. Patients will participate in a survey at the following timepoints- 4 hours, 24 hours, 48 hours and 7 days. The expectation is that this study will determine the effectiveness of using xylitol to decrease pain in orthodontic patients.

Enrollment

60 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participant and Parents able to sign and understand consent
  • Ability to chew gum

Exclusion criteria

  • Pregnant or Breastfeeding women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Xylitol Gum
Active Comparator group
Description:
Chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day.
Treatment:
Drug: Xylitol Gum
No Gum
No Intervention group
Description:
Control group that will refrain from chewing gum.

Trial contacts and locations

1

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Central trial contact

Peter Ngan, DMD; Karissa Spokane

Data sourced from clinicaltrials.gov

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