NCT03301714

Brief Summary

The study aims to assess the efficacy of an oral health education group based activity versus an individual based oral health education activity in terms of changes in oral health related quality of life (OHRQoL), self-efficacy and oral health knowledge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1.4 years

First QC Date

September 28, 2017

Results QC Date

March 2, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

motivational interviewingelderlyoral health

Outcome Measures

Primary Outcomes (2)

  • Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)

    The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life.

    change from baseline to 12 months

  • Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).

    Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy.

    change from baseline to 12 months

Secondary Outcomes (1)

  • Change in Oral Health Knowledge (Khanagar, 2014)

    change from baseline to 12 months

Study Arms (3)

Control: Standard of Care

NO INTERVENTION

Regular dental care under the standard clinic operation

Intervention 1: Group-based oral health education

EXPERIMENTAL

Group based oral health education

Behavioral: Oral Health Education

Intervention 2: Individual-based oral health education

EXPERIMENTAL

Individual-based motivational interviewing

Behavioral: Oral Health Education

Interventions

Group-based oral health education vs Individual-based oral health education using motivational interviewing

Intervention 1: Group-based oral health educationIntervention 2: Individual-based oral health education

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 55 years old or older.
  • May be new, regular, emergency patients attending the TUKSoD clinic at Kleinlife or clinics at the Dental School or utilizing medical and social services at Kleinlife who have the intention to become patients of record at the dental clinic.
  • Must be able to speak and understand English.
  • Must be willing to provide consent to participate in the study for himself/herself.

You may not qualify if:

  • Subjects younger than 55 years old will be excluded from the study.
  • Subjects who do not provide consent for participation will be excluded from the study.
  • Subjects who do not speak and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple Univerity Kornberg School of Dentistry

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Interventions

Health Education, Dental

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health DentistryEnvironment and Public Health

Results Point of Contact

Title
Dr. Marisol Tellez Merchan
Organization
Kornber School of Dentistry

Study Officials

  • MARISOL TELLEZ, PhD

    Associate Professor Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 4, 2017

Study Start

October 15, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 12, 2020

Results First Posted

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations