Impact of an Oral Health Intervention
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ClinicalTrials.gov Identifier: NCT03921632 |
Recruitment Status :
Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Eating Disorder | Behavioral: Smiles Matter Oral Health Education Series | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Education Program Effectiveness
Outpatients and inpatients from UNC Center of Excellence for Eating Disorders clinic
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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 |
- 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.

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Ages Eligible for Study: | 13 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, North Carolina | |
UNC Center of Excellence for Eating Disorders Clinic | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Michael Roberts, DDS | University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT03921632 |
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. |
Anorexia nervosa Bulimia |
Feeding and Eating Disorders Mental Disorders |