Impact of an Oral Health Intervention

Eating Disorder Clinical Trial

Official title:

Impact of an Oral Health Intervention Among a Group of Patients With Eating Disorders (Anorexia Nervosa and Bulimia Nervosa)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921632
• Other study ID #: 15-3295
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: July 3, 2017

Study information

• Verified date: April 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia Nervosa
• Eating Disorder
• Feeding and Eating Disorders

Intervention

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

Locations

Country	Name	City	State
United States	UNC Center of Excellence for Eating Disorders Clinic	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change of Participants Able to Correctly Identify Possible Oral Effects of Eating Disorders	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.	Baseline, Week 6