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

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ClinicalTrials.gov Identifier: NCT03267914
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Seena Patel, A.T. Still University of Health Sciences

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.


Condition or disease Intervention/treatment Phase
Dental Caries Oral Cavity Cancer Oral Complications of Chemotherapy and Head/Neck Radiation Other: Tray Other: Brush Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomly assigned to receive fluoride therapy with either custom trays (Tray group) or by application with a toothbrush (Brush group).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Tray group
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
Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.

Active Comparator: Brush group
Patients will brush with the fluoride for 2 minutes each day.
Other: Brush
Patients will brush with the fluoride for 2 minutes each day.




Primary Outcome Measures :
  1. Fluoride use compliance [ Time Frame: 3 months ]
    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.

  2. Fluoride use compliance [ Time Frame: 6 months ]
    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. Fluoride use compliance [ Time Frame: 9 months ]
    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.

  4. Fluoride use compliance [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Dental caries incidence assessed at 4 time points [ Time Frame: 3 months ]
    To evaluate caries incidence clinically, the number of surfaces per tooth on which new caries appear will be documented on the Caries Assessment Form. Caries will be scored using the International Caries Classification and Management System criteria for clinical research. Surfaces will be scored as either I (no obvious decay) or II (obvious decay).

  2. Dental caries incidence assessed clinically at 4 time points [ Time Frame: 6 months ]
    To evaluate caries incidence clinically, the number of surfaces per tooth on which new caries appear will be documented on the Caries Assessment Form. Caries will be scored using the International Caries Classification and Management System criteria for clinical research. Surfaces will be scored as either I (no obvious decay) or II (obvious decay).

  3. Dental caries incidence assessed at 4 time points [ Time Frame: 9 months ]
    To evaluate caries incidence clinically, the number of surfaces per tooth on which new caries appear will be documented on the Caries Assessment Form. Caries will be scored using the International Caries Classification and Management System criteria for clinical research. Surfaces will be scored as either I (no obvious decay) or II (obvious decay).

  4. Dental caries incidence assessed at 4 time points [ Time Frame: 12 months ]
    To evaluate caries incidence clinically, the number of surfaces per tooth on which new caries appear will be documented on the Caries Assessment Form. Caries will be scored using the International Caries Classification and Management System criteria for clinical research. Surfaces will be scored as either I (no obvious decay) or II (obvious decay).


Other Outcome Measures:
  1. Dental caries incidence assessed radiographically at 2 time points [ Time Frame: 6 months ]
    To evaluate caries incidence radiographically, bitewing radiographs and periapical films (as needed) will be taken at 6 and 12 months after the initial examination visit.

  2. Dental caries incidence assessed radiographically at 2 time points [ Time Frame: 12 months ]
    To evaluate caries incidence radiographically, bitewing radiographs and periapical films (as needed) will be taken at 6 and 12 months after the initial examination visit.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267914


Contacts
Contact: Seena Patel, DMD. MPH 480-248-8107 sbpatel@atsu.edu
Contact: Ann Spolarich, RDH, PhD 480-248-8153 aspolarich@atsu.edu

Locations
United States, Arizona
A.T. Still University, Arizona School of Dentistry & Oral Health Recruiting
Mesa, Arizona, United States, 85206
Contact: Seena Patel, DMD, MPH    480-248-8108    sbpatel@atsu.edu   
Contact: Ann Spolarich, RDH, PhD    480-284-8153    aspolarich@atsu.edu   
Sponsors and Collaborators
A.T. Still University of Health Sciences
Investigators
Principal Investigator: Seena Patel, DMD, MPH A.T. Still University, Arizona School of Dentistry & Oral Health

Responsible Party: Seena Patel, Dentist, Associate Director of Oral Medicine and Assistant Professor, A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT03267914     History of Changes
Other Study ID Numbers: 2017-005
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Mouth Neoplasms
Stomatognathic Diseases
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs