Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of an Oral Health Intervention

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.
ClinicalTrials.gov Identifier: NCT03921632
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.

Condition or disease Intervention/treatment Phase
Eating Disorder Behavioral: Smiles Matter Oral Health Education Series Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Primary Purpose: Other
Official Title: Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : July 3, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Education Program Effectiveness
Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic
 Behavioral: Smiles Matter Oral Health Education Series
Three sessions scheduled 2 weeks apart consisting of 15-20 minutes of didactic learning, 10 minutes of a group/personal exercise, and 10 minutes of questions that the patients have on the topic discussed that day


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders [ Time Frame: Baseline, Week 6 ]
    A multiple choice survey inquiring about potential effects of eating disorders (e.g., Tooth erosion, Probable erosion sites, Tooth sensitivity, Dry mouth, Enlarged saliva glands, Oral cancer, or No pain) and Positive Self-Perception (e.g., Confidence, Appearance, Kissing, General Health Attendance) posed as Yes/No response.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient of the UNC Center for Excellence for Eating Disorders inpatient unit or outpatient clinic.
  • Diagnosis of anorexia nervosa or bulimia nervosa
  • Aged 13-50 years
  • English-speaking

Exclusion Criteria:

  • Decisionally impaired (i.e., Incapable of providing informed consent in the opinion of the primary care provider in UNC Center for Excellence for Eating Disorders)
  • Involuntarily committed to the inpatient service of the UNC Department of Psychiatry
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03921632


Locations
Layout table for location information
United States, North Carolina
UNC Center of Excellence for Eating Disorders Clinic
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Layout table for investigator information
Principal Investigator: Michael Roberts, DDS University of North Carolina, Chapel Hill
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03921632     History of Changes
Other Study ID Numbers: 15-3295
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared.
Time Frame: Beginning 9 to 36 months following publication
Access Criteria: The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Keywords provided by University of North Carolina, Chapel Hill:
Anorexia nervosa
Bulimia

Additional relevant MeSH terms:
Layout table for MeSH terms
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders