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Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

Open (Enrolling)
Periodontal Disease, Quality of Life

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Trial Information

Oral Health in Breast Cancer Survivors on Aromatase Inhibitors



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

- To determine the oral health-related quality of life among postmenopausal women with
early stage breast cancer who are receiving adjuvant AI therapy.

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


- 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

Type of Study:


Study Design:

Time Perspective: Cross-Sectional

Outcome Measure:

Periodontal diseases

Outcome Time Frame:

At the time of study visit

Safety Issue:


Principal Investigator

L. Susan Taichman, RDH MPH PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

September 2015

Related Keywords:

  • Periodontal Disease
  • Quality of Life
  • Breast cancer
  • Periodontal Diseases
  • Aromatase Inhibitors
  • Oral Health Related Quality of Life
  • Breast Neoplasms
  • Periodontal Diseases



Michigan Center For Oral Health Research (MCOHR)Ann Arbor, Michigan  48106