Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

— ORARAD II  

Official title:

Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients (ORARAD II)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05325970
• Other study ID #: IRB00091445
• Secondary ID: U01DE022939Pro00
• Status: Active, not recruiting
• Start date: February 2014
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dental Diseases
• Head and Neck Cancer
• Head and Neck Neoplasms
• Osteoradionecrosis
• Stomatognathic Diseases

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of North Carolina School of Dentistry	Chapel Hill	North Carolina
United States	University of Connecticut Health Center - School of Dental Medicine	Farmington	Connecticut
United States	University of Minnesota	Minneapolis	Minnesota
United States	New York University - College of Dentistry	New York	New York
United States	University of Pennsylvania School of Dental Medicine	Philadelphia	Pennsylvania

Sponsors (8)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Brigham and Women's Hospital, National Institute of Dental and Craniofacial Research (NIDCR), NYU Langone Health, UConn Health, University of Minnesota, University of North Carolina, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Caries	Dental caries will be ascertained through the examination parameters outlined by NHANES, and the results of this examination with be used to calculate DMFS scores.	7 years
Primary	Bleeding on probing is documented (yes/no) (Periodontal Measure 1)	Bleeding on probing is documented (yes/no) and a percentage of "yes" responses will be calculated.	7 years
Primary	Clinical attachment loss (CAL) (Periodontal Measure 2)	Clinical attachment loss (CAL) measured in mm	7 years
Primary	Pocket depth (Periodontal Measure 3)	Pocket depth measured in mm	7 years
Primary	Tooth Loss	"Tooth loss" will be defined as a dental extraction that has been performed or recommended. Change in number of teeth throughout the duration of the study will be documented.	7 years
Primary	Exposed intraoral bone	Exposed intraoral bone is documented clinically by a trained clinical examiner and assessed based on a visual examination of the area, documenting the related tooth numbers or area and the following clinical signs: pain, swelling, induration, sequestrum, thin skin and/or beard loss (i.e. tissue hypoxia), evidence of pathologic fracture, tooth mobility, altered sensation in the affected area. The percentage of patients experiencing exposed bone, their recovery rates, and percent experiencing the signs will be calculated.	7 years
Primary	Salivary flow	Salivary flow is measured by the whole stimulated salivary flow rate. Changes in the rate and any association with other outcomes (e.g., caries) will be calculated.	7 years
Secondary	Trismus measurements in mm	Change in mouth opening are documented in mm	7 years
Secondary	7-year use of fluoride	Patients complete a questionnaire on use of fluoride (other than over the counter toothpaste), type, and frequency. Percent compliance with fluoride use and change in fluoride use will be calculated.	7 years
Secondary	Compliance with brushing/flossing	Patients complete a questionnaire on frequency of brushing and flossing. Percent compliance with brushing and flossing guidelines (2x per day according to evidence-based professional guidelines) and change in compliance will be calculated.	7 years
Secondary	Changes in RT-specific quality of life measures	Patients complete a likert scale questionnaire on 10 quality of life measures based on the European Organization for Research and Treatment of Cancer questionnaire. Ten individual question items were scored on a four-point scale indicating level of difficulty with daily tasks (1=not at all; 2=a little; 3=quite a bit; 4=very much).	7 years
Secondary	Change in pain scores	Patients complete a likert scale questionnaire on pain levels during 8 daily activities rating their pain from no pain (0) to the worst pain imaginable (5) based on the European Organization for Research and Treatment of Cancer questionnaire.	7 years
Secondary	Mortality		7 years
Secondary	Cancer recurrence		7 years