Trial Outcomes & Findings for Oral Health Education Interventions Among Seniors (NCT NCT03301714)
NCT ID: NCT03301714
Last Updated: 2020-05-12
Results Overview
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.
COMPLETED
NA
180 participants
change from baseline to 12 months
2020-05-12
Participant Flow
Participant milestones
| Measure |
Control: Standard of Care
Regular dental care under the standard clinic operation
|
Intervention 1: Group-based Oral Health Education
Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Intervention 2:Individual-based Oral Health Education Using MI
Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
50
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
7
|
Reasons for withdrawal
| Measure |
Control: Standard of Care
Regular dental care under the standard clinic operation
|
Intervention 1: Group-based Oral Health Education
Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Intervention 2:Individual-based Oral Health Education Using MI
Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
4
|
|
Overall Study
Did not receive allocated intervention
|
0
|
2
|
3
|
Baseline Characteristics
Oral Health Education Interventions Among Seniors
Baseline characteristics by cohort
| Measure |
Control
n=60 Participants
Regular dental care under the standard clinic operation
|
Intervention 1
n=60 Participants
Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Intervention 2
n=60 Participants
Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
69.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
69.9 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Oral Health Related Quality of Life
|
11.1 units on a scale
STANDARD_DEVIATION 10.5 • n=5 Participants
|
14.5 units on a scale
STANDARD_DEVIATION 13.4 • n=7 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 13.1 • n=5 Participants
|
13.9 units on a scale
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Self Efficacy
|
25.6 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
23.4 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
24.2 units on a scale
STANDARD_DEVIATION 6.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 12 monthsThe 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.
Outcome measures
| Measure |
Control
n=60 Participants
Regular dental care under the standard clinic operation
|
Intervention 1
n=60 Participants
Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Intervention 2
n=60 Participants
Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
|---|---|---|---|
|
Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)
|
16.8 score on a scale
Standard Deviation 11.4
|
12.4 score on a scale
Standard Deviation 11.2
|
10.5 score on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: change from baseline to 12 monthsOral 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.
Outcome measures
| Measure |
Control
n=60 Participants
Regular dental care under the standard clinic operation
|
Intervention 1
n=60 Participants
Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Intervention 2
n=60 Participants
Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
|---|---|---|---|
|
Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).
|
23.5 score on a scale
Standard Deviation 6.6
|
24.5 score on a scale
Standard Deviation 7.5
|
27.6 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsOral 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.
Outcome measures
| Measure |
Control
n=60 Participants
Regular dental care under the standard clinic operation
|
Intervention 1
n=60 Participants
Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
Intervention 2
n=60 Participants
Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing
|
|---|---|---|---|
|
Change in Oral Health Knowledge (Khanagar, 2014)
When gums bleed during brushing....
|
9 Participants
|
11 Participants
|
12 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
health of mouth directly related to body..
|
48 Participants
|
43 Participants
|
46 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
You can chew just as well with dentures as with
|
15 Participants
|
19 Participants
|
16 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Older adults with dry mouth get more cavities
|
29 Participants
|
18 Participants
|
18 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
The most common cause of dry mouth is medication
|
31 Participants
|
33 Participants
|
27 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
It is normal for people to have pain and sores in
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Individuals who do not cooperate for daily mouth c
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Name Box Insert Function Dental check-ups are as i
|
52 Participants
|
54 Participants
|
52 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
People can lose their teeth if they remain dirty
|
48 Participants
|
45 Participants
|
48 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
As people get old they naturally lose their teeth
|
19 Participants
|
23 Participants
|
23 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Dentures that don't fit well can cause oral cancer
|
12 Participants
|
10 Participants
|
16 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Dentures should be removed for few hours every day
|
26 Participants
|
26 Participants
|
27 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
People with no teeth need to be seen by dentist
|
41 Participants
|
35 Participants
|
39 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Mouth rinsing is a good alternative to daily tooth
|
12 Participants
|
21 Participants
|
20 Participants
|
|
Change in Oral Health Knowledge (Khanagar, 2014)
Older adults with teeth need to use fluorides
|
35 Participants
|
38 Participants
|
31 Participants
|
Adverse Events
Control
Intervention 1
Intervention 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place