Trial Outcomes & Findings for Oral Health Literacy Tailored Communication (NCT NCT01118143)
NCT ID: NCT01118143
Last Updated: 2015-04-16
Results Overview
The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.
COMPLETED
NA
179 participants
6 months after intervention
2015-04-16
Participant Flow
Participants were recruited from the waiting list at Tromsø University Dental Clinic. The recruitment started in May 2010 after approval from the regional ethical committee. Information letter with consent form was provided.
Enrolled participants: Total excluded n=46 * Not meeting the inclusion criteria (n=11) * Declined to participate (n=35)
Participant milestones
| Measure |
Experiment: Communication Adapted to Health Literacy Level
Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
|
Control: Short Standard Information
Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
69
|
|
Overall Study
COMPLETED
|
62
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Experiment: Communication Adapted to Health Literacy Level
Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
|
Control: Short Standard Information
Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
Baseline Characteristics
Oral Health Literacy Tailored Communication
Baseline characteristics by cohort
| Measure |
Individualized Oral Health Instruction
n=64 Participants
Individualized oral health instruction adapted to the patients oral health literacy level
|
Ordinary Oral Health Instruction
n=69 Participants
Oral health instruction commonly used in general practice
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=39 Participants
|
63 Participants
n=41 Participants
|
117 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 15.19 • n=39 Participants
|
46.4 years
STANDARD_DEVIATION 14.23 • n=41 Participants
|
47.9 years
STANDARD_DEVIATION 14.73 • n=35 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
76 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
57 Participants
n=35 Participants
|
|
Region of Enrollment
Norway
|
64 participants
n=39 Participants
|
69 participants
n=41 Participants
|
133 participants
n=35 Participants
|
|
health literacy level
Inadequate health literacy
|
15 paticipants
n=39 Participants
|
24 paticipants
n=41 Participants
|
39 paticipants
n=35 Participants
|
|
health literacy level
Marginal health literacy
|
36 paticipants
n=39 Participants
|
25 paticipants
n=41 Participants
|
61 paticipants
n=35 Participants
|
|
health literacy level
Adequate health literacy
|
13 paticipants
n=39 Participants
|
20 paticipants
n=41 Participants
|
33 paticipants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 months after interventionThe gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.
Outcome measures
| Measure |
Individualized Oral Health Instruction
n=64 Participants
Individualized oral health instruction adapted to the patients oral health literacy level
|
Ordinary Oral Health Instruction
n=69 Participants
Oral health instruction commonly used in general practice
|
|---|---|---|
|
Gingival Index
|
0.7190 units on a scale
Standard Deviation 0.41599
|
1.1152 units on a scale
Standard Deviation 0.45838
|
SECONDARY outcome
Timeframe: 6 months after interventionThe plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque. The Plaque index reference is Silness and Löe, 1964.
Outcome measures
| Measure |
Individualized Oral Health Instruction
n=64 Participants
Individualized oral health instruction adapted to the patients oral health literacy level
|
Ordinary Oral Health Instruction
n=69 Participants
Oral health instruction commonly used in general practice
|
|---|---|---|
|
Plaque Index
|
0.0805 units on a scale
Standard Deviation 0.12958
|
0.3386 units on a scale
Standard Deviation 0.34694
|
Adverse Events
Individualized Oral Health Instruction
Control
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