Orthodontic Pain Alleviation With Chewing Gum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xylitol Gum.
- Who it may be relevant to
- Registry conditions: Orthodontic Appliances. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Xylitol Gum
1 gram of xylitol per piece of gum with one serving being 2 pieces of gum
Primary outcome measures
- Visual analogue scale Baseline [Time frame: Baseline]
- Visual analogue scale 4 hours post treatment [Time frame: 4 hours post treatment]
- Visual analogue scale 24 hours post treatment [Time frame: 24 hours post treatment]
- Visual analogue scale 48 hours post treatment [Time frame: 48 hours post treatment]
- Visual analogue scale 1 week post treatment [Time frame: 1 week post treatment]
- Comfort Level for Biting Baseline [Time frame: Baseline]
- Comfort Level for Biting 4 hours post treatment [Time frame: 4 hours post treatment]
- Comfort Level for Biting 24 hours post treatment [Time frame: 24 hours post treatment]
- Comfort Level for Biting 48 hours post treatment [Time frame: 48 hours post treatment]
- Comfort Level for Biting 1 week post treatment [Time frame: 1 week post treatment]
Eligibility criteria
Inclusion criteria
- Participant and Parents able to sign and understand consent
- Ability to chew gum
Exclusion criteria
- Pregnant or Breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- West Virginia University — Morgantown
Identifiers
NCT: NCT07210697 · 2506181765