NCT05703789

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2022Nov 2027

First Submitted

Initial submission to the registry

November 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2027

Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

November 23, 2022

Last Update Submit

January 26, 2023

Conditions

Oral Health Related Quality of Life

Keywords

prosthetic rehabilitationeating disorderquality of lifedental

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Orofacial function (JFL-S)

    Before treatment

  • Orofacial function (JFL-S)

    4 months

  • Orofacial function (JFL-S)

    12 months

  • Orofacial function (JFL-S)

    24 months

  • Oral aesthetics (OES).

    Before treatment

  • +3 more secondary outcomes

Study Arms (2)

Oral rehabilitation

EXPERIMENTAL

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

Waiting list

OTHER

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

Interventions

Dental rehabilitation with either composite resin of crown therapyPROCEDURE

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.

Oral rehabilitation
Waiting listOTHER

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

Waiting list

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastman Dental Institute

Stockholm, 1 1324, Sweden

RECRUITING

Related Publications (3)

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

    PMID: 8193981BACKGROUND

  • 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.

    PMID: 18780535BACKGROUND

  • 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.

    PMID: 20552092RESULT

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Central Study Contacts

Ulrica Gidlund, DDS

CONTACT

+46735089213ulrica.gidlund@ki.se

Goran Dahllof, PhD

CONTACT

+46706479733goran.dahllof@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2022

First Posted

January 30, 2023

Study Start

December 27, 2022

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

November 15, 2027

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)