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Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693731
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : May 20, 2015
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Linda Susan Taichman, University of Michigan

Brief Summary:
The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex, Aromasin or Femara affect a woman's oral health and oral health related quality of life. Patients, dental professionals and medical oncologists will benefit from a greater understanding of the best oral care follow up practices of breast cancer survivors using aromatase inhibitors.

Condition or disease
Periodontal Disease Quality of Life

Detailed Description:



This cross-sectional prevalence study seeks to investigate the incidence and severity of oral health changes, specifically of periodontal conditions, among breast cancer survivors and the ways in which these outcomes affect their quality of life.


  • To determine the prevalence and severity of oral conditions in postmenopausal women with early stage breast cancer using adjuvant AI therapy as compared to postmenopausal women not using adjuvant AI therapy.
  • To determine if adjuvant AI therapy use is associated with greater alveolar bone loss or increased levels of bone turnover biomarkers in postmenopausal women with cancer undergoing adjuvant AI therapy compared to postmenopausal women not receiving AI therapy.
  • To determine the oral health-related quality of life among postmenopausal women with early stage breast cancer who are receiving adjuvant AI therapy.

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Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Cross-Sectional
Official Title: Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Study Start Date : April 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Aromatase Inhibitor
Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
No Treatment
Healthy volunteer postmenopausal women not taking Aromatase Inhibitors

Primary Outcome Measures :
  1. Periodontal diseases [ Time Frame: At the time of study visit ]

Secondary Outcome Measures :
  1. Alveolar bone loss using salivary and serum-derived bone markers. [ Time Frame: At the time of study visit ]
  2. Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire [ Time Frame: At the time of study visit ]

Biospecimen Retention:   Samples With DNA
Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be collected at the study visit.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will have a sample of 300 postmenopausal women; 150 healthy women and 150 with early breast cancer using Aromatase Inhibitors

Inclusion Criteria:

Postmenopausal as defined by NCCN (any of the following)

  • Prior bilateral oophorectomy
  • Age equal to or greater then 60 years of age
  • Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression and FSH and estradiol in the postmenopausal range
  • If taking tamoxifen or toremifen and age less then 60y, then FSH and plasma estradiol level in postmenopausal ranges

Informed consent- Individuals capable of consenting and self administering the survey instrument Dentate- At least 15 teeth present.

AI users:

  • Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease.
  • Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole) > 1 month. Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study.


  • No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of localized thyroid or skin cancer).

Exclusion Criteria:

Medical history

  • Metastatic BCa (AI treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).
  • Significant psychiatric illness/social situations that would preclude completion of questionnaire.


  • Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). NSAIDS and bisphosphonates are permitted.
  • Premedication- Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.)

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 identifier (NCT number): NCT01693731

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United States, Michigan
Michigan Center For Oral Health Research (MCOHR)
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: L. Susan Taichman, RDH MPH PhD University of Michigan

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Responsible Party: Linda Susan Taichman, Principal Investigator, University of Michigan Identifier: NCT01693731    
Other Study ID Numbers: 5K23DEO21779
5K23DE021779 ( U.S. NIH Grant/Contract )
HUM00048451 ( Other Identifier: UM MEDIRB )
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Linda Susan Taichman, University of Michigan:
Breast cancer
Periodontal Diseases
Aromatase Inhibitors
Oral Health Related Quality of Life
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs