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Head and Neck CancerORARADNCT02057510

Observational Study of Dental Outcomes in Head and Neck Cancer Patients

An observational study of Head and Neck Cancer and Dental Disease, run by Wake Forest University Health Sciences at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer, Dental Disease, Xerostomia
How many people
613 participants
Where
6 sitesUnited States
Study dates
Feb 2014to 28 Jan 2020
How long will I take part?
24 Months
Phase
Observational
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

Study population: Head and Neck Radiation Oncology patients

Who may be able to join

  • Aged 18 years and older;
  • Willing and able to provide signed and dated consent form;
  • Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
  • OR
  • Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:
  • base of tongue
Show all 34Show fewer
  • buccal/labial mucosa
  • epiglottis
  • floor of mouth
  • gingiva/alveolar ridge
  • hard palate
  • hypopharynx
  • larynx
  • lip
  • mandible
  • maxilla
  • maxillary sinus
  • nasal cavity
  • nasopharynx
  • neck
  • oral cavity
  • oral tongue
  • oropharynx
  • paranasal sinus/orbit
  • parotid gland
  • pharynx
  • retromolar trigone
  • soft palate
  • sublingual gland
  • submandibular gland
  • tonsil;
  • At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any;
  • Willing to comply with all study procedures;
  • Willing to participate for the duration of the study.

Who cannot join

  • Receiving palliative RT;
  • History of prior curative RT to the head and neck region to eradicate a malignancy;
  • Incarcerated at time of screening;
  • Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • University of North Carolina - School of Dentistry

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center - Dental Clinic

    Charlotte, North Carolina, 28203

  • University of Connecticut Health Center - School of Dental Medicine

    Farmington, Connecticut, 06030

  • New York University - College of Dentistry

    New York, New York, 10010

  • University of Pennsylvania - School of Dental Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.

Read the detailed description

This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-five participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.

Keywords
Head and Neck Cancer, Radiation Therapy
Medical subject headings
Head and Neck Neoplasms, Stomatognathic Diseases, Xerostomia, Osteoradionecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02057510
Study groupRoleWhat they receive
Patients receiving head and neck RTNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tooth loss

    The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer.

    "Tooth loss" will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction:

    • non-restorable because of fracture or extent of caries;
    • amputated crown with root remaining;
    • uncontrolled or persistent periodontal or odontogenic infection.

    Measured: Two Years

Secondary outcomes (10)

  1. Incidence of exposed intraoral bone

    Two year incidence of exposed intraoral bone, suggestive of ORN. This will be defined as exposed maxillary or mandibular bone with an avascular appearance in a quadrant that has received RT

    Measured: Two Years

  2. Extraction complications

    Incidence of post-extraction complications

    Measured: Within 14 days following procedure

  3. Decayed, Missing or Filled Surfaces (DMFS) Index

    Two year change in DMFS - Decayed, Missing or Filled Surfaces Index

    Measured: Baseline, 24 months

  4. Periodontal Measures

    Two year change in periodontal measures

    Measured: Baseline, 24 months

  5. Stimulated Salivary Flow Rate

    18 month changes in stimulated whole salivary flow rates

    Measured: Baseline, 18 months

  6. Trismus measure

    Two year change in mouth opening in mm

    Measured: Baseline, 24 months

  7. Topical fluoride use for caries prevention

    Two year use of fluoride to prevent new caries

    Measured: Baseline, 24 months

  8. Chronic Oral Mucositis Incidence

    Two year chronic oral mucositis incidence

    Measured: Baseline, 24 months

  9. Quality of Life after Radiation Therapy

    Two year change in radiation therapy-specific quality of life measures

    Measured: Baseline, 24 months

  10. Oral Cancer Pain Scale

    Two year change in pain scores as measured with the University of California at San Francisco (UCSF) oral cancer pain scale

    Measured: Baseline, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completion28 Jan 2020
  4. Study completion28 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
613 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057510
Sponsor's protocol ID
12-040-E
Other IDs
1U01DE022939-01
Acronym
ORARAD
Status last verified
Jun 2026
First submitted
5 Feb 2014
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Mohammadi K, Long Simpson L, Voelker H, Hodges JS, Lalla RV. Dental disease before radiotherapy in patients with head and neck cancer: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients. J Am Dent Assoc. 2017 Dec;148(12):868-877. doi: 10.1016/j.adaj.2017.09.011.

    PubMed 29173331

  • Lalla RV, Treister N, Sollecito T, Schmidt B, Patton LL, Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral complications at 6 months after radiation therapy for head and neck cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710. Epub 2017 Aug 3.

    PubMed 28675770

  • Lalla RV, Long-Simpson L, Hodges JS, Treister N, Sollecito T, Schmidt B, Patton LL, Brennan MT; OraRad Study Group. Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations. BMC Oral Health. 2017 Feb 27;17(1):59. doi: 10.1186/s12903-017-0344-y.

    PubMed 28241807

  • Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Yang Y, Lin A, Elting LS, Hodges JS, Lalla RV. Epidemiologic factors in patients with advanced head and neck cancer treated with radiation therapy. Head Neck. 2021 Jan;43(1):164-172. doi: 10.1002/hed.26468. Epub 2020 Sep 29.

    PubMed 32991009

  • Talevi V, Wen J, Lalla RV, Brennan MT, Mougeot FB, Mougeot JC. Identification of single nucleotide pleomorphisms associated with periodontal disease in head and neck cancer irradiation patients by exome sequencing. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jul;130(1):32-42.e4. doi: 10.1016/j.oooo.2020.02.013. Epub 2020 May 22.

    PubMed 32451231

  • Mougeot JC, Stevens CB, Almon KG, Paster BJ, Lalla RV, Brennan MT, Mougeot FB. Caries-associated oral microbiome in head and neck cancer radiation patients: a longitudinal study. J Oral Microbiol. 2019 Mar 8;11(1):1586421. doi: 10.1080/20002297.2019.1586421. eCollection 2019.

    PubMed 30891159

  • Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Hodges JS, Lalla RV. Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad) Study. Int J Radiat Oncol Biol Phys. 2022 Jun 1;113(2):320-330. doi: 10.1016/j.ijrobp.2021.11.021. Epub 2021 Dec 5.

    PubMed 34879248

  • Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.

    PubMed 35304084

  • Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Helgeson ES, Lalla RV. Dental Caries Postradiotherapy in Head and Neck Cancer. JDR Clin Trans Res. 2023 Jul;8(3):234-243. doi: 10.1177/23800844221086563. Epub 2022 Apr 11.

    PubMed 35403479

  • Lin A, Helgeson ES, Treister NS, Schmidt BL, Patton LL, Elting LS, Lalla RV, Brennan MT, Sollecito TP. The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study. Oral Oncol. 2022 Apr;127:105783. doi: 10.1016/j.oraloncology.2022.105783. Epub 2022 Feb 26.

    PubMed 35231809

  • Treister NS, Brennan MT, Sollecito TP, Schmidt BL, Patton LL, Mitchell R, Haddad RI, Tishler RB, Lin A, Shadick R, Hodges JS, Lalla RV. Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Study of Dental Outcomes in Head and Neck Cancer Patients (OraRad). Cancer. 2022 Feb 1;128(3):487-496. doi: 10.1002/cncr.33948. Epub 2021 Oct 19.

    PubMed 34665873

  • Ward MC, Carpenter MD, Noll J, Carrizosa D, Moeller BJ, Helgeson ES, Lalla RV, Brennan MT. Oncologists' Perspective on Dental Care Around the Treatment of Head and Neck Cancer: A Pattern of Practice Survey. JCO Oncol Pract. 2022 Jan;18(1):e28-e35. doi: 10.1200/OP.20.00913. Epub 2021 Jul 9.

    PubMed 34242067

  • Threet EJ, Napenas JJ, Petersen C, Mitchell R, Long-Simpson L, Shadick R, Valentino KC, Rybczyk CA, Blake JA, Brown MC, Aidoo R, Helgeson ES, Lalla RV, Brennan MT. Survey of experiences and barriers to dental care post-head and neck cancer in OraRad study participants. Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Apr;135(4):501-509. doi: 10.1016/j.oooo.2022.11.011. Epub 2022 Dec 13.

    PubMed 36717342

  • Lalla RV, Hodges JS, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Brennan MT. Tooth-level predictors of tooth loss and exposed bone after radiation therapy for head and neck cancer. J Am Dent Assoc. 2023 Jun;154(6):519-528.e4. doi: 10.1016/j.adaj.2023.03.009.

    PubMed 37236706

  • Patton LL, Helgeson ES, Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Lin A, Chera BS, Lalla RV. Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study. Support Care Cancer. 2023 Apr 20;31(5):286. doi: 10.1007/s00520-023-07750-2.

    PubMed 37079106

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer and Dental Disease, run by Wake Forest University Health Sciences at 6 sites 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 34 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tooth loss (time frame: Two Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057510, which also lists 20 linked publications.

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 30 Jun 2026.

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