An observational study in Head and Neck Cancer, Dental Disease and Xerostomia, sponsored by Wake Forest University Health Sciences. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 613 is above the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Head and Neck Radiation Oncology patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Diagnosed with a non-SCC, non-SGC 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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
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.
Time frame: Two Years
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
Time frame: Two Years
Extraction complications
Incidence of post-extraction complications
Time frame: Within 14 days following procedure
Decayed, Missing or Filled Surfaces (DMFS) Index
Two year change in DMFS - Decayed, Missing or Filled Surfaces Index
Time frame: Baseline, 24 months
Periodontal Measures
Two year change in periodontal measures
Time frame: Baseline, 24 months
Stimulated Salivary Flow Rate
18 month changes in stimulated whole salivary flow rates
Time frame: Baseline, 18 months
Trismus measure
Two year change in mouth opening in mm
Time frame: Baseline, 24 months
Topical fluoride use for caries prevention
Two year use of fluoride to prevent new caries
Time frame: Baseline, 24 months
Chronic Oral Mucositis Incidence
Two year chronic oral mucositis incidence
Time frame: Baseline, 24 months
Quality of Life after Radiation Therapy
Two year change in radiation therapy-specific quality of life measures
Time frame: Baseline, 24 months
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
Time frame: Baseline, 24 months
The record gives a start of Feb 2014, a primary completion of Jan 2020 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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