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NCT Number: NCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

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.

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Key information

Conditions

Head and Neck Carcinoma Head and Neck Neoplasms Malignant Parotid Gland Neoplasm Maxillary Sinus Carcinoma Maxillary Sinus Neoplasms Mouth Diseases Mouth Neoplasms Nasal Cavity Carcinoma Neoplasms Neoplasms by Site Nose Diseases Nose Neoplasms Oral Cavity Carcinoma Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Paranasal Sinus Diseases Paranasal Sinus Neoplasms Parotid Diseases Parotid Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases Tongue Carcinoma Tongue Diseases Tongue Neoplasms Tonsillar Carcinoma Tonsillar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner Health/Banner Research, Phoenix, Arizona, United States

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About this study

PRIMARY OBJECTIVE:

I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.

SECONDARY OBJECTIVES:

I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.

OUTLINE: Patients are randomized to 1 of 2 arms.

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

ARM II: Patients receive standard of care during treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Medical Device Usage and Evaluation

Other

Wear 3D printed oral stent

Primary outcomes

  1. Mucositis toxicity rates

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Patient reported outcomes

    Time frame: Through study completion, an average of 1 year

    Will be assessed using the MD Anderson Symptom Inventory Head and Neck questionnaire. T test or Wilcoxon rank sum test will be used to compare scores of each item per time point or sums of scores across all items at each time point or sums across three time point per item between the two arms. Multivariate analyses such as linear regression model adjusting for the effects of covariates might be performed to compare patients reported outcomes. Appropriate data transformation will be performed if necessary for assumption of normality.

  2. Patients narcotics diaries

    Time frame: Through study completion, an average of 1 year

    Will record the worst, the least, the average pain score and pain score at present for each day. Will calculate the average of these 4 scores as a composite daily pain score.

  3. Imaging difference

    Time frame: Through study completion, an average of 1 year

    The set up error during radiation will be measured in each treatment arm.

  4. Dosimetric difference

    Time frame: Through study completion, an average of 1 year

    The radiation dose to healthy tissue will be measured in each treatment arm.

  5. Composite pain scores

    Time frame: Through study completion, an average of 1 year

    An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa.

  6. Number of narcotic pills used

    Time frame: Through study completion, an average of 1 year

    An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Lee, MD

CONTACT

[email protected]

932-750-1920

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 3, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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