West Virginia University
Morgantown, West Virginia, 26506, United States
NCT Number: NCT07210697
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 opening soon.
Get NotifiedUp to 18 year
All sexes
Interventional
Phase 3
Morgantown, West Virginia, 26506, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 gram of xylitol per piece of gum with one serving being 2 pieces of gum
Time frame: 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: 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: 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: 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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Karissa Spokane
CONTACT
Peter Ngan, DMD
CONTACT
West Virginia University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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