What this study is
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.
What's being tested
- Xylitol Gum
Intervention · DRUG
1 gram of xylitol per piece of gum with one serving being 2 pieces of gum
Study details
- Sponsor
- West Virginia University
- Conditions
- Orthodontic Appliances
- Enrolling
- 60 people
- Starts
- 2025-10
- Est. completion
- 2026-03
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participant and Parents able to sign and understand consent
- Ability to chew gum
You can't join if
- Pregnant or Breastfeeding women
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openWest Virginia University
Morgantown, West Virginia, United States
- Peter, DMD · Contact304-293-3223
- Karissa Spokane · Contact724-630-5624kls0006@mix.wvu.edu
Study team
Sponsor
West Virginia University
Study ID 2506181765
Principal investigator
Peter Ngan, DMD
West Virginia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.