Malignant Head and Neck NeoplasmNCT05126797
3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy
A study testing Questionnaire Administration and Stent Device in people with Malignant Head and Neck Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how a customized 3D-printed oral stent compares to a standard stent made by a dentist for use in imaging scans in patients with head and neck cancer receiving radiation therapy. Oral stents are designed to help prevent radiation-related side effects while receiving radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Head and Neck Neoplasm
- What is being tested?
- Questionnaire Administration and Stent Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2017to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy.
- Treating radiation oncologist has determined the necessity of an oral stent and a device has been fabricated by dentistry at MD Anderson Cancer Center (MDACC).
- Patient has received pre-treatment imaging which includes the mandibular and maxillary dentition.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Signed study-specific consent form.
Who cannot join
- No pre-treatment computed tomography (CT) imaging including the maxilla and mandible is available.
- Prior head and neck radiotherapy.
- Severe trismus with an incisal opening of < 10 mm.
- Inability to comply with the study procedures.
- Patients who have received dental stents fabricated outside of MDACC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Printed Oral Stents for Patients Receiving Head and Neck Radiation Therapy
This trial studies how a customized 3D-printed oral stent compares to a standard stent made by a dentist for use in imaging scans in patients with head and neck cancer receiving radiation therapy. Oral stents are designed to help prevent radiation-related side effects while receiving radiation therapy. Traditional oral stents are created by dentists, require at least 2 separate appointments, and may not be as cost-effective. A customized, 3D-printed oral stent may perform as well as a standard stent made by a dentist and have a significantly shorter turnaround to device delivery.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
SECONDARY OBJECTIVES:
- To evaluate the performance of the 3D stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing.
II. Evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment.
III. To evaluate the commercially available TruGuard oral cavity positioning system.
OUTLINE:
Patients wear a customized 3D printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. Patients may also optionally wear the commercially-made stent called TruGuard at these timepoints.
- Conditions
- Malignant Head and Neck Neoplasm
- Being tested
- Questionnaire Administration, Stent Device
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Stent DeviceDevice
Also called Stent
Wear customized 3D printed oral stent
| Study group | Role | What they receive |
|---|---|---|
| 3D printed stent+ MDASI-3D Oral Stents Questionnaire | Other | Patients wear a customized 3D printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. Patients may also optionally wear the commercially-made stent called TruGuard at these timepoints. Ancillary Studies (MDASI-3D Oral Stents Questionnaire) Receives: Other: Questionnaire Administration; Device: Stent Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
The patient will fill out a questionnaire that measures the form and fit of the 3D printed oral stent at specified time points, and this measurement will be compared with a standard stent. Score ranges(0-10) 0 None at all-10 As bad as you can imagine.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start11 Oct 2017
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Why it stopped: Administrativley Complete, \<75% Participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eugene J Koay, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126797
- Sponsor's protocol ID
- 2017-0269
- Other IDs
- NCI-2019-02460, 2017-0269
- Status last verified
- Mar 2025
- First submitted
- 3 Sep 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Oral Stents for Patients Receiving Head and Neck Radiation Therapy
- ClinicalTrials.gov ID
- NCT05126797
- Acronym / sponsor ID
- 2017-0269
- Conditions
- Malignant Head and Neck Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrativley Complete, \<75% Participants
- Enrolment
- 57 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how a customized 3D-printed oral stent compares to a standard stent made by a dentist for use in imaging scans in patients with head and neck cancer receiving radiation therapy. Oral stents are designed to help prevent radiation-related side effects while receiving radiation therapy. Traditional oral stents are created by dentists, require at least 2 separate appointments, and may not be as cost-effective. A customized, 3D-printed oral stent may perform as well as a standard stent made by a dentist and have a significantly shorter turnaround to device delivery.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
SECONDARY OBJECTIVES:
- To evaluate the performance of the 3D stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing.
II. Evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment.
III. To evaluate the commercially available TruGuard oral cavity positioning system.
OUTLINE:
Patients wear a customized 3D printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. Patients may also optionally wear the commercially-made stent called TruGuard at these timepoints.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printed stent+ MDASI-3D Oral Stents Questionnaire | Other | Other: Questionnaire Administration, Device: Stent DevicePatients wear a customized 3D printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. Patients may also optionally wear the commercially-made stent called TruGuard at these timepoints. Ancillary Studies (MDASI-3D Oral Stents Questionnaire) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy.
- Treating radiation oncologist has determined the necessity of an oral stent and a device has been fabricated by dentistry at MD Anderson Cancer Center (MDACC).
- Patient has received pre-treatment imaging which includes the mandibular and maxillary dentition.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Signed study-specific consent form.
Key exclusion criteria (5 listed)
- No pre-treatment computed tomography (CT) imaging including the maxilla and mandible is available.
- Prior head and neck radiotherapy.
- Severe trismus with an incisal opening of < 10 mm.
- Inability to comply with the study procedures.
- Patients who have received dental stents fabricated outside of MDACC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | 3D printed stent+ MDASI-3D Oral Stents Questionnaire |
| Stent DeviceAlso: StentWear customized 3D printed oral stent | Device | 3D printed stent+ MDASI-3D Oral Stents Questionnaire |
Primary outcome
To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
Time frame: up to 2 months
The patient will fill out a questionnaire that measures the form and fit of the 3D printed oral stent at specified time points, and this measurement will be compared with a standard stent. Score ranges(0-10) 0 None at all-10 As bad as you can imagine.
Results and safety
The study was stopped early (reason given: Administrativley Complete, \<75% Participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- M.D. Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene J Koay principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Stent Device in people with Malignant Head and Neck Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administrativley Complete, \<75% Participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment. (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.