Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

NCT04870762 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: 2020-1153NCI-2021-03221
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 7

Brief Summary

This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.

Conditions

Head and Neck Carcinoma; Malignant Parotid Gland Neoplasm; Maxillary Sinus Carcinoma; Nasal Cavity Carcinoma; Oral Cavity Carcinoma; Tongue Carcinoma; Tonsillar Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mucositis toxicity rates

  Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score.

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Patient reported outcomes

  Through study completion, an average of 1 year

• Patients narcotics diaries

  Through study completion, an average of 1 year

• Imaging difference

  Through study completion, an average of 1 year

• Dosimetric difference

  Through study completion, an average of 1 year

• Composite pain scores

  Through study completion, an average of 1 year

Study Arms (2)

Arm I (3D printed oral stent)

EXPERIMENTAL

Patients wear 3D printed oral stent during standard of care radiotherapy.

Other: Best Practice; Other: Medical Device Usage and Evaluation

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care during treatment.

Other: Best Practice; Other: Medical Device Usage and Evaluation

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm I (3D printed oral stent); Arm II (standard of care)

Medical Device Usage and Evaluation OTHER

Wear 3D printed oral stent

Arm I (3D printed oral stent); Arm II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy
• Age 18 or older
• ECOG PS 0-2
• The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)
• Signed study-specific consent form

You may not qualify if:

• Prior head and neck radiotherapy
• Participants is unable to fit a tongue-lateralizing or tongue-depressing stent
• Severe trismus with an incisal opening of \<10 mm
• Inability to comply with the study procedures
• Participants younger than 18 years of age
• Participants must not be pregnant
• Cognitively impaired subjects

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (7)

Banner Health/Banner Research

Phoenix, Arizona, 85234, United States

RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

Community MD Anderson Cancer Center East

Indianapolis, Indiana, 46219, United States

RECRUITING

Community MD Anderson Cancer Center South

Indianapolis, Indiana, 46227, United States

RECRUITING

Community MD Anderson Cancer Center North

Indianapolis, Indiana, 46250, United States

RECRUITING

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Parotid Neoplasms; Maxillary Sinus Neoplasms; Mouth Neoplasms; Tongue Neoplasms; Tonsillar Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases; Paranasal Sinus Neoplasms; Nose Neoplasms; Otorhinolaryngologic Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Tongue Diseases; Oropharyngeal Neoplasms; Pharyngeal Neoplasms; Pharyngeal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Anna Lee

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lee, MD

CONTACT

932-750-1920; alee13@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: May 26, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (7)