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

Study Overview
=================
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.

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

Conditions
-----------------
Head and Neck Cancer, Dental Diseases, Osteoradionecrosis

Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohorts Interventions Patients receiving head and neck RT<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Clinical attachment loss (CAL) (Periodontal Measure 2) | Clinical attachment loss (CAL) measured in mm | 7 years | 
| Pocket depth (Periodontal Measure 3) | Pocket depth measured in mm | 7 years | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trismus measurements in mm | Change in mouth opening are documented in mm | 7 years | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Mortality |  | 7 years | 
| Cancer recurrence |  | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental outcomes, cancer, registry