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

NCT05325970 | Active Not Recruiting DMC

• 3 other identifiers: IRB00091445U01DE022939Pro00060322
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 6

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.

Conditions

Osteoradionecrosis; Head and Neck Cancer; Dental Diseases

Keywords

dental outcomes; cancer; registry

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Trismus measurements in mm

  7 years

• 7-year use of fluoride

  7 years

• Compliance with brushing/flossing

  7 years

• Changes in RT-specific quality of life measures

  7 years

• Change in pain scores

  7 years

Study Arms (1)

Cohorts Interventions Patients receiving head and neck RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• UConn Health: collaborator
• University of Pennsylvania: collaborator
• Brigham and Women's Hospital: collaborator
• NYU Langone Health: collaborator
• University of North Carolina: collaborator
• Wake Forest University Health Sciences: lead
• University of Minnesota: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (6)

University of Connecticut Health Center - School of Dental Medicine

Farmington, Connecticut, 06030, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

New York University - College of Dentistry

New York, New York, 10010, United States

Location

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27514, United States

Location

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104-6030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatognathic Diseases; Osteoradionecrosis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Radiation Injuries; Wounds and Injuries

Study Officials

• Michael T. Brennan, DDS, MHS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Rajesh V. Lalla, DDS, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 13, 2022
• Study Start: February 1, 2014
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: immediately after publication, no expiration
• Access Criteria: send request to either Dr. Brennan (mike.brennan@atriumhealth.org) or Dr. Rajesh Lalla (lalla@uconn.edu).

Locations

US (6)