Orthodontic Pain Alleviation With Chewing Gum

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT07210697
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Orthodontic Appliances

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Xylitol Gum — DRUG
    1 gram of xylitol per piece of gum with one serving being 2 pieces of gum

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Visual analogue scale Baseline [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
West Virginia UniversityMorgantownWest Virginia26506
Peter, DMD
304-293-3223
Karissa Spokane
724-630-5624

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