A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management
Fuzzle Operating Co.
Summary
This study is evaluating whether the Fuzzle intraoral device can help adults with obesity lose weight when used alongside standard lifestyle counseling. Participants in this study will receive guidance on diet and behavior to support weight loss. Some participants will also receive the Fuzzle device, a custom-made removable oral appliance worn during the day. The study will compare weight loss outcomes between participants who use the Fuzzle device and those who follow lifestyle counseling alone over a 16-week period. Researchers will also explore whether use of the device increases the number of participants who achieve meaningful weight loss and may evaluate changes in selected metabolic markers in a subset of participants.
Description
The purpose of this study is to evaluate the effectiveness of the Fuzzle intraoral device as an adjunct to standardized lifestyle counseling for weight management in adults with obesity (BMI ≥30 kg/m², ages 18-65). This randomized, controlled study compares participants receiving the Fuzzle device in combination with standardized lifestyle counseling to those receiving lifestyle counseling alone over a 16-week period. The primary objective is to assess whether use of the Fuzzle device results in greater percent total body weight loss at 16 weeks compared to standardized lifestyle counseling…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 18-65 years * Body mass index (BMI) ≥30 kg/m² at screening * Willing and able to provide informed consent * Willing to comply with study visits and procedures * Willing to participate in standardized lifestyle counseling Exclusion Criteria: * Participation in another weight-loss clinical study within 90 days * Pregnancy, breastfeeding, or intent to become pregnant during the study period * History of eating disorders or uncontrolled psychiatric illness * Oral or dental conditions preventing safe device use * Current use of prescription or over-the-counter w…
Interventions
- DeviceFuzzle Intraoral Device
The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear as an adjunct to weight management. The device is created from dental impressions to ensure a patient-specific fit. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene. The device is intended to modulate oral sensory input within the stomatognathic system, with the goal of influencing eating-related behaviors, including reductions in snacking frequency and alterations in meal patterns. It is non-invasive, reversible, and used in a home setting under provider supervision.
- BehavioralLifestyle Management
Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.
Location
- DM Clinical ResearchBradenton, Florida