Trial Outcomes & Findings for Oral Health Literacy and Oral Education (NCT NCT02436811)

Last Updated: 2016-05-06

Results Overview

The knowledge score was assessed by nine statements developed and tested in a pilot study including items related to breastfeeding, supplemental feeding, sugar intake, bottle use, oral hygiene, and use of fluoride toothpaste. These statements were rated on a three-level Likert scale, under the following options: "agree," "neither agree nor disagree," and "disagree," in addition to "I don't know." Each correct answer received score 1 whereas incorrect answers such as "neither agree nor disagree" and "I don't know" were assigned score 0. The final scores ranged from 0 to 9. Higher values indicate better outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.

Results posted on

2016-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Standardized Oral Instruction women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.	Written Form Instruction women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).	Control women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Overall Study STARTED	60	60	60
Overall Study COMPLETED	58	51	53
Overall Study NOT COMPLETED	2	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Standardized Oral Instruction women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.	Written Form Instruction women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).	Control women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Overall Study Lost to Follow-up	2	9	7

Baseline Characteristics

Oral Health Literacy and Oral Education

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standardized Oral Instruction n=60 Participants 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.	Written Form Instruction n=60 Participants 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).	Control n=60 Participants 60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=99 Participants	12 Participants n=107 Participants	8 Participants n=206 Participants	32 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=99 Participants	48 Participants n=107 Participants	52 Participants n=206 Participants	148 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Continuous	26.60 years STANDARD_DEVIATION 5.74 • n=99 Participants	26.32 years STANDARD_DEVIATION 6.19 • n=107 Participants	25.58 years STANDARD_DEVIATION 6.59 • n=206 Participants	26.22 years STANDARD_DEVIATION 6.24 • n=7 Participants
Sex: Female, Male Female	60 Participants n=99 Participants	60 Participants n=107 Participants	60 Participants n=206 Participants	180 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment Brazil	60 participants n=99 Participants	60 participants n=107 Participants	60 participants n=206 Participants	180 participants n=7 Participants

PRIMARY outcome

Timeframe: The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.

Outcome measures

Outcome measures
Measure	Standardized Oral Instruction n=58 Participants women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.	Written Form Instruction n=51 Participants women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).	Control n=53 Participants women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Changes in the Knowledge Score Pre-test	4.81 units on a scale Standard Deviation 1.45	4.86 units on a scale Standard Deviation 1.56	4.64 units on a scale Standard Deviation 1.39
Changes in the Knowledge Score Post-test	7.10 units on a scale Standard Deviation 1.52	5.84 units on a scale Standard Deviation 1.73	4.74 units on a scale Standard Deviation 1.58
Changes in the Knowledge Score 4-week interval	6.34 units on a scale Standard Deviation 1.45	5.41 units on a scale Standard Deviation 1.56	4.83 units on a scale Standard Deviation 1.38

Adverse Events

Standardized Oral Instruction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Written Form 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

Serious adverse events
Measure	Standardized Oral Instruction 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.	Written Form Instruction 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).	Control 60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Social circumstances knowledge score variation	— 0/0 • 1 month The total number of "0" of participants at risk means that no serious adverse events were assessed as this study aimed to verify the gain of information in oral health during the follow-up period.	— 0/0 • 1 month The total number of "0" of participants at risk means that no serious adverse events were assessed as this study aimed to verify the gain of information in oral health during the follow-up period.	— 0/0 • 1 month The total number of "0" of participants at risk means that no serious adverse events were assessed as this study aimed to verify the gain of information in oral health during the follow-up period.

Other adverse events

Other adverse events
Measure	Standardized Oral Instruction 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.	Written Form Instruction 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).	Control 60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Social circumstances knowledge score variation	— 0/0 • 1 month The total number of "0" of participants at risk means that no serious adverse events were assessed as this study aimed to verify the gain of information in oral health during the follow-up period.	— 0/0 • 1 month The total number of "0" of participants at risk means that no serious adverse events were assessed as this study aimed to verify the gain of information in oral health during the follow-up period.	— 0/0 • 1 month The total number of "0" of participants at risk means that no serious adverse events were assessed as this study aimed to verify the gain of information in oral health during the follow-up period.

Additional Information

Dr Luciana Reichert Assunção Zanon

Universidade Federal do Paraná

Phone: 554133604025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place