Oral Health in Patients With Severe Eating Disorders

Oral Health in Patients With Severe Eating Disorders An Interview, Questionnaire and Intervention Study With a Focus on Quality of Life

The overall aim of the research project is to assess whether the quality of life of patients with severe eating disorders is improved by dental treatment.

Patients diagnosed with anorexia nervosa, bulimia nervosa or non-specific binge eating disorder with extensive dental treatment need will be treated with resin composite restorations or prosthetic therapy. The primary outcome measures is oral health related quality of life. Secondary are orofacial functions and oral esthetics. Patients will be compared to a waiting list.

Study Overview

• Status: Recruiting
• Conditions: Oral Health Related Quality of Life
• Intervention / Treatment: Procedure: Dental rehabilitation with either composite resin of crown therapy; Other: Waiting list

Detailed Description

III. Do patients with severe eating disorders experience a difference in quality of life following oral rehabilitation with minimal invasive treatment or prosthetic treatment? - A prospective clinical 2-year follow-up

HYPOTHESIS The hypothesis is that patients with severe eating disorders do not exhibit any difference in terms of Oral Health Related Quality of Life following oral rehabilitation or not (null hypotheses).

PATIENTS

Patients diagnosed with anorexia nervosa, bulimia nervosa or non-specific binge eating disorder who meet the inclusion criteria will consecutively be offered to participate in the study during years 2022-2023. Spoken and written information will be given, and written consent will be obtained from all participants prior to study start.

STUDY DESIGN We will conduct a randomized controlled clinical study that examines the effect of two dental treatments on Oral Health Related Quality of Life (OHRQoL) in patients with severe anorexia nervosa, bulimia nervosa or non-specific binge eating disorder. 90 patients will be randomized 2:1 to treatment or no treatment.

Inclusion criteria Patients diagnosed with anorexia nervosa, bulimia nervosa or non-specific binge eating disorder for a minimum of 10 years = definition of a "severe" eating disorder where extensive dental damage can be anticipated to find.

Need of dental treatment of at least six teeth in one jaw, since dental treatment need of ≤ than six teeth per jaw is not expected to cause a noticeable change in OHRQoL.

Exclusion criteria Age <18 years or patients unable to provide informed consent.

EXPOSURE/INTERVENTION Patients will be randomized to either oral rehabilitation or a waiting-list condition for 4-6 months. Patients receiving dental treatment will be allocated to one of two different treatment groups based on individual treatment need and proven experience. Patients in group 1 will be treated with minimal invasive treatment, with restorative composite fillings. Patients in group 2 will be treated with prosthetic rehabilitation, dental crowns. Patients that are randomized to no dental treatment will act as controls. The overall treatment results will be followed up after 4, 12 and 24 months. After the 4-6-month follow-up, the corresponding control patient from the waiting list will receive requisite dental treatment.

Adverse events Data of adverse events will be recorded post-dental treatment using an online questionnaire where participants will be able to describe any adverse event during treatment in detail. Patients who report at least one adverse event will receive follow-up questions about the duration and intensity of the event.

DATA COLLECTION The primary outcome, OHRQoL will be evaluated by means of a validated psychometrical instrument for reporting this: oral health impact (OHIP-49). Longitudinal comparison in patients receiving no treatment (controls). and treatment OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally. Additional outcome measures are orofacial function (JFL-S) and oral aesthetics (OES).

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulrica Gidlund, DDS; Phone Number: +46735089213; Email: ulrica.gidlund@ki.se
• Study Contact Backup: Name: Goran Dahllof, PhD; Phone Number: +46706479733; Email: goran.dahllof@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 1 1324
    • Recruiting
    • Eastman Dental Institute
    • Contact: Ulrica Gidlund, DDS; Phone Number: +46735089213; Email: ulrica.gidlund@ki.se
    • Sub-Investigator: Yvonne von Hausswolff-Juhlin, MD
    • Sub-Investigator: Anastasios Grigoriadis, DDS
    • Sub-Investigator: Pernilla Larsson, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with anorexia nervosa, bulimia nervosa or non-specific binge eating disorder for a minimum of 10 years = definition of a "severe" eating disorder where extensive dental damage can be anticipated to find.
• Need of dental treatment of at least six teeth in one jaw,

Exclusion Criteria:

• Age <18 years or patients unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral rehabilitation; Name Oral rehabilitation. Patients receiving dental treatment will be allocated to one of two different treatment groups based on individual treatment need and proven experience. Patients in group 1 will be treated with minimal invasive treatment, with restorative composite fillings. Patients in group 2 will be treated with prosthetic rehabilitation, dental crowns.	Procedure: Dental rehabilitation with either composite resin of crown therapy; Patients in group 1 will be treated with minimal invasive treatment, with restorative composite fillings. Patients in group 2 will be treated with prosthetic rehabilitation, dental crowns.
Other: Waiting list; Name: Waiting list. Patients in waiting list will receive no treatment. After four months they will be offered to be included in the oral rehabilitation arm.	Other: Waiting list; Waiting list. Patients randomized to this group will not receive any intervention but answer questionnaires after 4 months on waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health related quality of life OHIP-49	OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.	Before treatment
Oral health related quality of life OHIP-49	OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.	4 months
Oral health related quality of life OHIP-49	OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.	12 months
Oral health related quality of life OHIP-49	OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orofacial function (JFL-S)	JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws [18]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.	Before treatment
Orofacial function (JFL-S)	JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws [18]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.	4 months
Orofacial function (JFL-S)	JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws [18]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.	12 months
Orofacial function (JFL-S)	JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws [18]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.	24 months
Oral aesthetics (OES).	OES is an instrument used to evaluate self-perceived orofacial aesthetics and the reliability and validity has been investigated previously [19,26]. The instrument is an eight- item questionnaire which measures aesthetic components such as appearance of the face, facial profile, mouth, align- ment, tooth shape, tooth colour and gum as well as a gen- eral orofacial aesthetic assessment. Subjects respond on a 0-10 numeric rating scale (0- 'very dissatisfied', 10- 'very sat- isfied') or mark the answer 'not applicable' if they do not wish to answer. The total score can range from 0 to 70, where 70 is the highest score which indicates very high satis- faction. Subjects were allowed to ask questions if needed but answered the questionnaires on their own.	Before treatment
Oral aesthetics (OES).	OES is an instrument used to evaluate self-perceived orofacial aesthetics and the reliability and validity has been investigated previously [19,26]. The instrument is an eight- item questionnaire which measures aesthetic components such as appearance of the face, facial profile, mouth, align- ment, tooth shape, tooth colour and gum as well as a gen- eral orofacial aesthetic assessment. Subjects respond on a 0-10 numeric rating scale (0- 'very dissatisfied', 10- 'very sat- isfied') or mark the answer 'not applicable' if they do not wish to answer. The total score can range from 0 to 70, where 70 is the highest score which indicates very high satis- faction. Subjects were allowed to ask questions if needed but answered the questionnaires on their own.	4 months
Oral aesthetics (OES).	OES is an instrument used to evaluate self-perceived orofacial aesthetics and the reliability and validity has been investigated previously [19,26]. The instrument is an eight- item questionnaire which measures aesthetic components such as appearance of the face, facial profile, mouth, align- ment, tooth shape, tooth colour and gum as well as a gen- eral orofacial aesthetic assessment. Subjects respond on a 0-10 numeric rating scale (0- 'very dissatisfied', 10- 'very sat- isfied') or mark the answer 'not applicable' if they do not wish to answer. The total score can range from 0 to 70, where 70 is the highest score which indicates very high satis- faction. Subjects were allowed to ask questions if needed but answered the questionnaires on their own.	12 months
Oral aesthetics (OES).	OES is an instrument used to evaluate self-perceived orofacial aesthetics and the reliability and validity has been investigated previously [19,26]. The instrument is an eight- item questionnaire which measures aesthetic components such as appearance of the face, facial profile, mouth, align- ment, tooth shape, tooth colour and gum as well as a gen- eral orofacial aesthetic assessment. Subjects respond on a 0-10 numeric rating scale (0- 'very dissatisfied', 10- 'very sat- isfied') or mark the answer 'not applicable' if they do not wish to answer. The total score can range from 0 to 70, where 70 is the highest score which indicates very high satis- faction. Subjects were allowed to ask questions if needed but answered the questionnaires on their own.	24 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Public Dental Health Service in Stockholm AB

Publications and helpful links

General Publications

• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
• Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.
• Larsson P, John MT, Nilner K, Bondemark L, List T. Development of an Orofacial Esthetic Scale in prosthodontic patients. Int J Prosthodont. 2010 May-Jun;23(3):249-56.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Anticipated): December 15, 2026
• Study Completion (Anticipated): November 15, 2027

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; prosthetic rehabilitation; dental; eating disorder
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 2021-03601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No