Trial Outcomes & Findings for Oral Health Literacy Tailored Communication (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

179 participants

Primary outcome timeframe

6 months after intervention

Results posted on

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

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

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

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=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=113 Participants	63 Participants n=163 Participants	117 Participants n=160 Participants
Age, Categorical >=65 years	10 Participants n=113 Participants	6 Participants n=163 Participants	16 Participants n=160 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 15.19 • n=113 Participants	46.4 years STANDARD_DEVIATION 14.23 • n=163 Participants	47.9 years STANDARD_DEVIATION 14.73 • n=160 Participants
Sex: Female, Male Female	39 Participants n=113 Participants	37 Participants n=163 Participants	76 Participants n=160 Participants
Sex: Female, Male Male	25 Participants n=113 Participants	32 Participants n=163 Participants	57 Participants n=160 Participants
Region of Enrollment Norway	64 participants n=113 Participants	69 participants n=163 Participants	133 participants n=160 Participants
health literacy level Inadequate health literacy	15 paticipants n=113 Participants	24 paticipants n=163 Participants	39 paticipants n=160 Participants
health literacy level Marginal health literacy	36 paticipants n=113 Participants	25 paticipants n=163 Participants	61 paticipants n=160 Participants
health literacy level Adequate health literacy	13 paticipants n=113 Participants	20 paticipants n=163 Participants	33 paticipants n=160 Participants

PRIMARY outcome

Timeframe: 6 months after intervention

Outcome measures

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 intervention

The 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Jan Bergdahl

University of Tromsø

Phone: +4777649122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place