Oral Stent Device for Radiation Treatments of Oral Cancers

A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04041141

Enrollment

Registered

2019-08-01

Start date

2019-09-25

Completion date

2021-02-03

Last updated

2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tongue Cancer, Tongue Tumor

Keywords

tongue tumor, tongue cancer, oral cancer

Brief summary

The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving \>55 Gy by 50%during radiation treatment as assessed duri radiation treatment planning. Patients will have CT scans at three time-points during their standard of care radiation treatment. During these visits patients will receive scans via CT or cone beam CT scan, with both the standard and experimental oral stent devices. During radiation treatment patients will receive the standard oral stent device.

Interventions

DIAGNOSTIC_TESTCT Scan

An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)

DEVICEExperimental Oral Stent Device

Patients undergoing standard of care planning for head and neck tongue cancer will have a radiation plan of the body imaged via CT scan construction with the experimental oral stent device in place

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥18 year old at the time of informed consent * Ability to provide written informed consent and HIPAA authorization * Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively * Signed consent to study participation * No history of bleeding disorder * Platelets within normal limits (150-450 k/cumm)

Exclusion criteria

* History of bleeding disorder * History of allergy to dental grade material

Design outcomes

Primary

Measure	Time frame
The volume of mandible irradiated to >55 Gy	volume irradiated at Day 0

Secondary

Measure	Time frame	Description
The position of the fiducial marker	Change in position at Day 0, Week 3, Week 5	Fiducial coordinate measured (mm) on XYZ on planning CT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026