NCT07210697

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Orthodontic Appliances

Keywords

Orthodontic Painxylitol gum

Outcome Measures

Primary Outcomes (90)

  • 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.

    Baseline

  • 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.

    4 hours post treatment

  • 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.

    24 hours post treatment

  • 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.

    48 hours post treatment

  • Visual analogue scale 1 week 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.

    1 week post treatment

  • Comfort Level for Biting Baseline

    Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Comfort Level for Biting 4 hours post treatment

    Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Comfort Level for Biting 24 hours post treatment

    Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Comfort Level for Biting 48 hours post treatment

    Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Comfort Level for Biting 1 week post treatment

    Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Comfort Level for Chewing Baseline

    Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Comfort Level for Chewing 4 hours post treatment

    Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Comfort Level for Chewing 24 hours post treatment

    Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Comfort Level for Chewing 48 hours post treatment

    Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Comfort Level for Chewing 1 week post treatment

    Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Comfort Level for Fitting Back Teeth Baseline

    Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Comfort Level for Fitting Back Teeth 4 hours post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Comfort Level for Fitting Back Teeth 24 hours post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Comfort Level for Fitting Back Teeth 48 hours post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Comfort Level for Fitting Back Teeth 1 week post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Comfort Level for Fitting Front Teeth Baseline

    Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Comfort Level for Fitting Front Teeth 4 hours post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Comfort Level for Fitting Front Teeth 24 hours post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Comfort Level for Fitting Front Teeth 48 hours post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Comfort Level for Fitting Front Teeth 1 week post treatment

    Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Comfort Level for Speech Baseline

    Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Comfort Level for Speech 4 hours post treatment

    Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Comfort Level for Speech 24 hours post treatment

    Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Comfort Level for Speech 48 hours post treatment

    Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Comfort Level for Speech 1 week post treatment

    Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Comfort Level for popping and clicking of the jaw joint Baseline

    Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Comfort Level for popping and clicking of the jaw joint 4 hours post treatment

    Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Comfort Level for popping and clicking of the jaw joint 24 hours post treatment

    Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Comfort Level for popping and clicking of the jaw joint 48 hours post treatment

    Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Comfort Level for popping and clicking of the jaw joint 1 week post treatment

    Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 \[very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with appearance of teeth Baseline

    Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with appearance of teeth 4 hours post treatment

    Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with appearance of teeth 24 hours post treatment

    Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with appearance of teeth 48 hours post treatment

    Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with appearance of teeth 1 week post treatment

    Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with appearance of facial profile Baseline

    Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with appearance of facial profile 4 hours post treatment

    Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with appearance of facial profile 24 hours post treatment

    Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with appearance of facial profile 48 hours post treatment

    Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with appearance of facial profile 1 week post treatment

    Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with general appearance of face Baseline

    Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with general appearance of face 4 hours post treatment

    Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with general appearance of face 24 hours post treatment

    Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with general appearance of face 48 hours post treatment

    Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with general appearance of face 1 week post treatment

    Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with overall appearance Baseline

    Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with overall appearance 4 hours post treatment

    Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with overall appearance 24 hours post treatment

    Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with overall appearance 48 hours post treatment

    Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with overall appearance 1 week post treatment

    Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with general health Baseline

    Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with general health 4 hours post treatment

    Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with general health 24 hours post treatment

    Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with general health 48 hours post treatment

    Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with general health 1 week post treatment

    Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with self-esteem Baseline

    Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with self-esteem 4 hours post treatment

    Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with self-esteem 24 hours post treatment

    Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with self-esteem 48 hours post treatment

    Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with self-esteem 1 week post treatment

    Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with socializing Baseline

    Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 \[confident in socializing (0) to neutral (5) to avoid socializing (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with socializing 4 hours post treatment

    Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 \[confident in socializing (0) to neutral (5) to avoid socializing (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with socializing 24 hours post treatment

    Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 \[confident in socializing (0) to neutral (5) to avoid socializing (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with socializing 48 hours post treatment

    Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 \[confident in socializing (0) to neutral (5) to avoid socializing (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with socializing 1 week post treatment

    Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 \[confident in socializing (0) to neutral (5) to avoid socializing (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with school performance Baseline

    Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with school performance 4 hours post treatment

    Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with school performance 24 hours post treatment

    Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with school performance 48 hours post treatment

    Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with school performance 1 week post treatment

    Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Satisfaction with being out in public Baseline

    Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    Baseline

  • Satisfaction with being out in public 4 hours post treatment

    Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    4 hours post treatment

  • Satisfaction with being out in public 24 hours post treatment

    Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    24 hours post treatment

  • Satisfaction with being out in public 48 hours post treatment

    Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    48 hours post treatment

  • Satisfaction with being out in public 1 week post treatment

    Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 \[very good (0) to neutral (5) to very bad (10)\] with 0 being the best outcome and 10 being the worst.

    1 week post treatment

  • Self-Reported Level of Neuroticism Baseline

    Measured using the question "How do you fall on a scale of neuroticism?" Investigators provide the definition of neuroticism as the following: Neuroticism is a tendency to experience emotions such as anxiety, depression, and anger. The scale used is a Likert type scale with 0= Very Neurotic, 5= Somewhat Neurotic, and 10= Not Neurotic. Higher scores indicate lower levels of neuroticism.

    Baseline

  • Self-Reported Introversion/extroversion Baseline

    Measured using the question "How do you fall on a scale of introversion/extroversion?" Investigators provide the definition of neuroticism as the following: Introvert is someone who is socially reserved; Ambivert falls in the middle; Extrovert is someone who is very socially outgoing. The scale used is a Likert type scale with 0= Introvert, 5= Ambivert, and 10= Extrovert. Higher scores indicate higher levels of being socially outgoing.

    Baseline

  • Adherence to chewing gum instructions 4 hours post treatment

    Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.

    4 hours post treatment

  • Adherence to chewing gum instructions 24 hours post treatment

    Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.

    24 hours post treatment

  • Adherence to chewing gum instructions 48 hours post treatment

    Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.

    48 hours post treatment

  • Adherence to chewing gum instructions 1 week post treatment

    Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.

    1 week post treatment

  • Adherence to avoiding pain medications instructions 4 hours post treatment

    Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.

    4 hours post treatment

  • Adherence to avoiding pain medications instructions 24 hours post treatment

    Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.

    24 hours post treatment

  • Adherence to avoiding pain medications instructions 48 hours post treatment

    Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.

    48 hours post treatment

  • Adherence to avoiding pain medications instructions 1 week post treatment

    Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.

    1 week post treatment

Study Arms (2)

Xylitol Gum

ACTIVE COMPARATOR

Chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day.

Drug: Xylitol Gum

No Gum

NO INTERVENTION

Control group that will refrain from chewing gum.

Interventions

Xylitol GumDRUG

1 gram of xylitol per piece of gum with one serving being 2 pieces of gum

Xylitol Gum

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnant or Breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Study Officials

  • Peter Ngan, DMD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ngan, DMD

CONTACT

304-293-3223pngan@hsc.wvu.edu

Karissa Spokane

CONTACT

724-630-5624kls0006@mix.wvu.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Chair, Orthodontics

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

October 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)