Oral Health in Patients With Severe Eating Disorders

NCT ID: NCT05703789

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2027-11-15

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).

Conditions

Oral Health Related Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dental rehabilitation with either composite resin of crown therapy

Intervention Type: PROCEDURE

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.

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.

Group Type: OTHER

Waiting list

Intervention Type: OTHER

Waiting list. Patients randomized to this group will not receive any intervention but answer questionnaires after 4 months on waiting list

Interventions

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.

Intervention Type: PROCEDURE

Waiting list

Waiting list. Patients randomized to this group will not receive any intervention but answer questionnaires after 4 months on waiting list

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Public Dental Health Service in Stockholm AB

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Göran Dahllöf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eastman Dental Institute

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Ulrica Gidlund, DDS

Role: CONTACT

ulrica.gidlund@ki.se

+46735089213

Goran Dahllof, PhD

Role: CONTACT

goran.dahllof@ki.se

+46706479733

Facility Contacts

Ulrica Gidlund, DDS

Role: primary

ulrica.gidlund@ki.se

+46735089213

References

Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.

Reference Type: BACKGROUND

PMID: 8193981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18780535 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20552092 (View on PubMed)

Other Identifiers

2021-03601

Identifier Type: -

Identifier Source: org_study_id