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NCT06801535 · ClinicalTrials.gov registry record · NA
Efficacy of 3D-Printed Mouth Splints
A NA study of Microstomia, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06801535: Recruiting NA study of Microstomia, sponsored by Wake Forest University Health Sciences.
NCT06801535 is a NA study of Microstomia that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06801535, a NA study of Microstomia, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. The validated Mouth Impairment and Disability Assessment (MIDA) survey will be used to objectively measure patient progress in functionality and quality of life.
Primary Outcome
Difference in measurements of oral aperture from Baseline visit to Final visit will be reported - Oral aperture measurements taken with calipers
Conditions Studied
Interventions
- DEVICE Splint
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-02-21 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06801535 shows while recruiting
NCT06801535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Microstomia appearing as the primary indexed condition, and to 1 intervention - of which Splint is the first listed.
NCT06801535 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06801535 about?
NCT06801535 is a clinical study titled "Efficacy of 3D-Printed Mouth Splints". The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. The validated Mouth Impairment and Disability Assessment (MIDA) survey will be used to objectively measure patient prog...
What is the current status of trial NCT06801535?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-02-21. Estimated completion is 2026-12.
What conditions does trial NCT06801535 study?
This clinical trial studies the following conditions: Microstomia.
What interventions are being tested in trial NCT06801535?
The interventions under investigation include: Splint (DEVICE).
Who is sponsoring clinical trial NCT06801535?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06801535 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06801535's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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