Orthodontic Pain Alleviation With Chewing Gum
ConditionOrthodontic Appliances
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant and Parents able to sign and understand consent
Ability to chew gum
Disqualifiers
Pregnant or Breastfeeding women
Trial design
Design model
Parallel
Treatments tested in this trial
Xylitol Gum
Drug1 gram of xylitol per piece of gum with one serving being 2 pieces of gum
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Xylitol GumActive comparator 1 intervention
Group B: No GumNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Visual analogue scale Baseline
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Time frame
Baseline2
Visual analogue scale 4 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Time frame
4 hours post treatment3
Visual analogue scale 24 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Time frame
24 hours post treatment4
Visual analogue scale 48 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Time frame
48 hours post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: