Clinical trial NCT05703789: Oral Health in Patients With Severe Eating Disorders
Official title: Oral Health in Patients With Severe Eating Disorders An Interview, Questionnaire and Intervention Study With a Focus on Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Health Related Quality of Life
Keywords: prosthetic rehabilitation
eating disorder
quality of life
dental
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Public Dental Health Service in Stockholm AB
First posted: 2023-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Oral health related quality of life OHIP-49
timeFrame: Before treatment
measure: Oral health related quality of life OHIP-49
timeFrame: 4 months
measure: Oral health related quality of life OHIP-49
timeFrame: 12 months
measure: Oral health related quality of life OHIP-49
timeFrame: 24 months
Secondary outcomes:
measure: Orofacial function (JFL-S)
timeFrame: Before treatment
measure: Orofacial function (JFL-S)
timeFrame: 4 months
measure: Orofacial function (JFL-S)
timeFrame: 12 months
measure: Orofacial function (JFL-S)
timeFrame: 24 months
measure: Oral aesthetics (OES).
timeFrame: Before treatment
measure: Oral aesthetics (OES).
timeFrame: 4 months
measure: Oral aesthetics (OES).
timeFrame: 12 months
measure: Oral aesthetics (OES).
timeFrame: 24 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eastman Dental Institute
Study officials:
References:
citation: Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
citation: 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.
citation: 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.