Oral Health Related Quality of Life | NCT05923762

Studies
Oral Health Related Quality of Life

NCT05923762

Sponsor

Dalarna County Council, Sweden

Status

Unknown status

Last Update Posted

Jun 28, 2023Actual

Enrollment

3,700Estimated

Phase

Not provided

Conditions

Oral Health Related Quality of Life
Oral Disease

Interventions

OHRQoL

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2024Estimated

Primary Completion Date

Jul 15, 2025Estimated

Completion Date

Jul 15, 2025Estimated

First Submitted Date

Jun 15, 2023

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jun 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2023

Last Update Posted Date

Jun 28, 2023Actual

Name	Class
Region Gävleborg	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to circumstances. FDI World Dental federations definition of oral health is; "Oral health is multifaceted and includes the ability to speak, smile, smell, taste, touch, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18-85 years of age			Behavioral: OHRQoL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OHRQoL	Behavioral	Oral health-related quality of life will be measured by the "Oral Impact on Daily Performance" (OIDP)	18-85 years of age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OHRQoL	Questionnaire, Oral health problems in the last six months with eating, cleaning teeth, socializing. The questionnaire used will be OIDP	2024-01-15 - 2024-12-31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Read and understand Swedish -

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

The target population is adults aged 18-85 years that resides in Region Dalarna, Sweden.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009059	Mouth Diseases

Ancestor Terms

ID	Term
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided