Orthodontic Pain Alleviation With Chewing Gum

NCT ID: NCT07210697

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Orthodontic Appliances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Xylitol Gum

Intervention Type DRUG

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

No Gum

Control group that will refrain from chewing gum.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Xylitol Gum

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant or Breastfeeding women
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Peter Ngan

Department Chair, Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Ngan, DMD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Central Contacts

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Peter Ngan, DMD

Role: CONTACT

304-293-3223

Karissa Spokane

Role: CONTACT

724-630-5624

Facility Contacts

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Peter, DMD

Role: primary

304-293-3223

Karissa Spokane

Role: backup

724-630-5624

Other Identifiers

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2506181765

Identifier Type: -

Identifier Source: org_study_id

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