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Completed

NCT Number: NCT03301714

Oral Health Education Interventions Among Seniors

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple Univerity Kornberg School of Dentistry

Philadelphia, Pennsylvania, 19140, United States

About this study

Older adults have been described as one of the most underserved and vulnerable groups, who are at the highest risk for coronal and root caries, especially because more elderly adults are retaining their teeth. The Northeast Philadelphia KleinLife site is an important destination for the region's Jewish population comprising of at least 6500 seniors, and assisting more than 4500 seniors through food security programs. Recently, Temple University Kornberg School of Dentistry (TUKSoD) purchased the dental center at the facility to expand the services provided to these underserved population and improve their oral health. 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. Methods: A non-probability sample of 190 senior members will be invited to participate in the trial. Potential subjects will be obtained in person through the ongoing flow of patients at TUKSoD Clinic at Kleinlife and the dental school. Seniors who consent to participate in the study will be randomly allocated to one of the 3 groups (Control: subjects will continue receiving regular dental care at the clinic, Intervention 1: subjects will continue receiving regular dental care at the clinic and be invited to participate in 2 group based education sessions during a 12 month period, and Intervention 2: subjects will continue receiving regular dental care at the clinic and be invited to participate in an individual-based education and prevention activity over a 18 month period. Randomization will be determined according to a predetermined random sequence, and neither the patient nor the research staff will be aware of the randomization outcome until after the patient has agreed to participate. The OHIP-14 will be used to assess OHRQoL, and self-efficacy scores will be the primary outcomes. Initially, we will assess the differences between the interventions and control using 2-sample t-tests. The main analysis will be based on linear mixed-effects models for repeated measures (using the OHIP 14 and self-efficacy scores as continuous outcome variables) to assess differences between intervention and control groups. Similar analyses will be conducted for secondary outcome measures Statistical significance will be set at p < .05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Oral Health Education

Behavioral

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

Primary outcomes

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

    Time frame: change from baseline to 12 months

    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.

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

    Time frame: change from baseline to 12 months

    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.

Secondary outcomes

  1. Change in Oral Health Knowledge (Khanagar, 2014)

    Time frame: change from baseline to 12 months

    Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Colgate Palmolive
  • KleinLife

Registry information

Official study title

Oral Health Education Interventions and Its Association With Behavioral Outcomes: A Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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