Clinical trial NCT05325970: Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients
Official title: Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients (ORARAD II)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Dental Diseases
Osteoradionecrosis
Keywords: dental outcomes
cancer
registry
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: University of Minnesota
name: UConn Health
name: University of Pennsylvania
name: Brigham and Women's Hospital
name: NYU Langone Health
name: University of North Carolina
First posted: 2022-04-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be offered to all living ORARAD participants approximately 7 years post-RT. Persons of all races and ethnicities and both females and males will thus be eligible for this study. Because participants will be drawn solely from the participants in the original ORARAD, the racial/ethnic composition of the study population at each center will be determined by the composition of those enrolled in the original ORARAD, which has been documented elsewhere. Since there is no evidence to suggest that dental outcomes in head and neck cancer patients are affected by gender, this expected unequal gender distribution of study participants will not affect the scientific validity of the study. Individuals who meet the eligibility criteria will be invited to participate in the study.

Brief summary: The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

Detailed description: This is a prospective cohort study to document long-term dental and other oral outcomes in patients who receive external beam and modern radiation therapy (RT) modalities with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-two participants were enrolled in the original study, ORARAD, which included a baseline oral examination prior to the start of radiation therapy and follow-up examinations and data collection at six-month intervals up to 2 years after the start of RT. The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the original ORARAD study
* Willing to participate and comply with all study procedures

Exclusion Criteria:

* Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study (e.g., unable to obtain consent or unable to tolerate an oral examination).

Primary outcomes:
measure: Dental Caries
timeFrame: 7 years
measure: Bleeding on probing is documented (yes/no) (Periodontal Measure 1)
timeFrame: 7 years
measure: Clinical attachment loss (CAL) (Periodontal Measure 2)
timeFrame: 7 years
measure: Pocket depth (Periodontal Measure 3)
timeFrame: 7 years
measure: Tooth Loss
timeFrame: 7 years
measure: Exposed intraoral bone
timeFrame: 7 years
measure: Salivary flow
timeFrame: 7 years
Secondary outcomes:
measure: Trismus measurements in mm
timeFrame: 7 years
measure: 7-year use of fluoride
timeFrame: 7 years
measure: Compliance with brushing/flossing
timeFrame: 7 years
measure: Changes in RT-specific quality of life measures
timeFrame: 7 years
measure: Change in pain scores
timeFrame: 7 years
measure: Mortality
timeFrame: 7 years
measure: Cancer recurrence
timeFrame: 7 years
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center - School of Dental Medicine
state: Connecticut
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: New York University - College of Dentistry
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael T. Brennan, DDS, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: UConn Health
name: Rajesh V. Lalla, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: