Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy

NCT03267914 | Completed

• 1 other identifier: 2017-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 40 people will participate in this study. This study will compare two different methods of fluoride application. Both methods are currently used in dental practice and both have been shown to be effective. If the participant chooses to participate in this study, participant will be asked to either wear a small tray that has been custom made to fit into the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be randomly assigned to use one of these methods of fluoride application: participant will not be allowed to choose which method of application you prefer. Participant will be asked to use fluoride every night while enrolled in the study. The fluoride that is used in the study is approved by the United States Food and Drug Administration and is commercially available with a prescription. After the study is over, participant will need to continue to use fluoride every night for life to help reduce the risk for dental cavities in the future. During the study, participant will receive a dental examination every 3 months for a total of 4 study visits over the period of 1 year. This visit will consist of a dental examination to identify any new cavities and instructions for fluoride use. Participant will also be asked to complete a written log to document daily fluoride use and to give feedback about compliance with fluoride use.

Conditions

Dental Caries; Oral Cavity Cancer; Oral Complications of Chemotherapy and Head/Neck Radiation

Outcome Measures

Primary Outcomes (4)

• Fluoride use compliance

  To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.

  3 months

• Fluoride use compliance

  To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.

  6 months

• Fluoride use compliance

  To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.

  9 months

• Fluoride use compliance

  To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.

  12 months

Secondary Outcomes (4)

• Dental caries incidence assessed at 4 time points

  3 months

• Dental caries incidence assessed clinically at 4 time points

  6 months

• Dental caries incidence assessed at 4 time points

  9 months

• Dental caries incidence assessed at 4 time points

  12 months

Other Outcomes (2)

• Dental caries incidence assessed radiographically at 2 time points

  6 months

• Dental caries incidence assessed radiographically at 2 time points

  12 months

Study Arms (2)

Tray group

EXPERIMENTAL

Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.

Other: Tray

Brush group

ACTIVE COMPARATOR

Patients will brush with the fluoride for 2 minutes each day.

Other: Brush

Interventions

Tray OTHER

Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.

Tray group

Brush OTHER

Patients will brush with the fluoride for 2 minutes each day.

Brush group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Diagnosis of cancer in the head and neck region
• Field of radiation must include the parotid gland(s) and/or submandibular gland region
• Able to speak English
• Able to provide consent
• Able to return for all study visits

You may not qualify if:

• Previous/current use of prescription strength fluoride
• Previous history of radiation to the head and neck region
• Presence of autoimmune disease(s)
• Currently pregnant
• Currently edentulous or will become edentulous prior to beginning radiation therapy

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

A.T. Still University, Arizona School of Dentistry & Oral Health

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Dental Caries; Mouth Neoplasms

Interventions

traY protein, E coli; Toothbrushing

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Seena Patel, DMD, MPH

  A.T. Still University, Arizona School of Dentistry & Oral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, Associate Director of Oral Medicine and Assistant Professor

Model Details: Subjects will be randomly assigned to receive fluoride therapy with either custom trays (Tray group) or by application with a toothbrush (Brush group).

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 31, 2017
• Study Start: August 29, 2017
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)