Oral Health Educational Methods in Adolescence

• Sponsor: Universidade Federal do Paraná (Other)
• Overall Status: Completed
• CT.gov ID: NCT03216746
• Collaborator: (none)
• Enrollment: 288
• Arms: 4
• Actual Duration (Months): 12

Study Details

Study Description

Brief Summary

Adolescence is a phase of important redefinitions and become an important period in the construction of new habits. Therefore, oral health education becomes strongly necessary, since good habits acquired at this stage may be perpetuated for adult life. The aim of this study is to evaluate the influence of an educational protocol on oral health in oral knowledge and clinical conditions in adolescence. A longitudinal study is being conducted with an initial sample of 291 adolescents enrolled in a public school in the city of Curitiba, Paraná, Brazil. The educational protocol was built in four phases. In phase I, the participants answered a questionnaire (pre-test) that included five statements about periodontal diseases and their forms of prevention. The answers were arranged in a Likert scale with a score of 1 (one) for the correct responses and 0 (zero) for the incorrect ones, obtaining, therefore, the knowledge score (KC). At this stage, adolescents is also being clinically assessed using simplified oral hygiene index (IHO-S) for dental plaque evaluation and gingival bleeding (ISG). In phase II, the sample (n = 291) is being randomly divided into two groups that receive two different educational interventions: oral orientation (OR) and video (VD). After each intervention, the questionnaire (post-test) is being reapplied. In the next phase (III), the study population (n = 291) is being again divided into four groups, and for two of them (OR + APP / VD + APP) a smartphone app was developed to messages which are being sending over a period of 30 days. In phase IV, the participants (n = 263) are answering again to the questionnaire (follow-up test) and are being reassessed clinically. Non-parametric tests and univariate and multivariate Poisson regression with robust variance will be used for statistical analysis (α = 0.05).

Condition or Disease	Intervention/Treatment	Phase
Adolescent Behavior	Behavioral: Oral orientation and App for smartphone; Behavioral: Oral orientation; Behavioral: Video orientation and App for smartphone; Behavioral: Video orientation	N/A

Detailed Description

A longitudinal study has been conducting with an initial sample of 291 adolescents enrolled in high school at a public school in the city of Curitiba, Paraná, Brazil. The educational protocol is characterized by four phases. In the first stage (Phase I), the participants are answering a questionnaire (pre-test) in order to verify the level of previous knowledge of the sample regarding periodontal diseases and their forms of prevention and are being clinically examined. In phase II the adolescents are randomly divided into two groups, which receive different educational methods: oral orientation (OR) and the application of a video (VD). After the educational interventions, the participants answer the questionnaire (post-test). In phase III, the two groups are being divided into four subgroups: oral orientation with App (OR+App), oral orientation without App (OR without App), video with App (VD+App) and video without App (VD without App). OR+App and VD+App received a mobile phone application specially developed for this study containing educational messages which are being during a period of 30 days. In the fourth phase (IV) the participants answer the questionnaire again (follow-up test) and are reassessed clinically.

Study Design

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Educational Methods in Oral Health for Adolescents: Influence on Knowledge and Oral Clinical Conditions
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Nov 15, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral orientation and App for smartphone The oral health educational method of this group comprised a total of 66 adolescents aged between 14 and 19 years who received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. The participants of this group also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.	Behavioral: Oral orientation and App for smartphone; 66 adolescents aged between 14 and 19 years. Participants enrolled in this group received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.
Experimental: Oral orientation The oral health educational method of this group comprised a total of 71 adolescents aged between 14 and 19 years who received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases.	Behavioral: Oral orientation; 71 adolescents aged between 14 and 19 years. Participants enrolled in this group received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes.
Experimental: Video orientation and App for smartphone The oral health educational method of this group comprised a total of 63 adolescentes aged between 14 and 19 years who received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The participants of this group also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.	Behavioral: Video orientation and App for smartphone; 63 adolescentes aged between 14 and 19 years. Participants enrolled in this group received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.
Experimental: Video orientation The oral health educational method of this group comprised a total of 63 adolescentes aged between 14 and 19 years who received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience.	Behavioral: Video orientation; 63 adolescentes aged between 14 and 19 years. Participants enrolled in this group received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes.

Outcome Measures

Primary Outcome Measures

1. Knowledge Score [30 days]

   The knowledge score varied from 13 (five) to 0 (zero). Higher scores means better outcomes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adolescents of both sexes

• Regularly enrolled in the high school of a public institution

Exclusion Criteria:

• Participants with physical or mental condition

• Absence of signing consent form

• Adolescents with fixed orthodontic apparatus

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidade Federal do Paraná

Investigators

• Principal Investigator: Luciana Zanon, PhD, Universidade Federal do Paraná

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 17, 2019

More Information

Publications

• Vilella KD, Fraiz FC, Benelli EM, Assunção LR. Oral Health Literacy and Retention of Health Information Among Pregnant Women: A Randomised Controlled Trial. Oral Health Prev Dent. 2017;15(1):41-48. doi: 10.3290/j.ohpd.a37712.

• Responsible Party: Luciana Reichert Assunção Zanon, Pediatric Dentistry, Universidade Federal do Paraná
• ClinicalTrials.gov Identifier: NCT03216746
• Other Study ID Numbers: 51712315.4.0000.0102
• First Posted: Jul 13, 2017
• Last Update Posted: May 5, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Luciana Reichert Assunção Zanon, Pediatric Dentistry, Universidade Federal do Paraná: oral health; knowledge; adolescent

Study Results

Participant Flow

Arm/Group Title	Oral Orientation With App	Oral Orientation Without App	Video With App	Video Without App
Arm/Group Description	The oral health educational method of this group comprised a total of 72 adolescents aged between 14 and 19 years who received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days. Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes.	The oral health educational method of this group comprised a total of 79 adolescents aged between 14 and 19 years who received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes. In this group, participants did not receive the App for smartphone. Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes.	The oral health educational method of this group comprised a total of 68 adolescentes aged between 14 and 19 years who received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days. Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes.	The oral health educational method of this group comprised a total of 69 adolescentes aged between 14 and 19 years who received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes. In this group, participants did not receive the App for smartphone. Oral health educational methods: An educational protocol including different methods of education will be evaluated through the knowledge score and periodontal indexes.
Period Title: Overall Study
STARTED	72	79	68	69
COMPLETED	66	71	63	63
NOT COMPLETED	6	8	5	6

Baseline Characteristics

Arm/Group Title	Oral Orientation Without App	Video Without App	Oral Orientation With App	Video With App	Total
Arm/Group Description	This group comprised of 79 adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher.	This group comprised of 69 adolescents from 14 to 19 years of age who received a video orientation.	This group comprised of 72 adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher and also from an App developed specifically for this study.	This group comprised of 68 adolescents from 14 to 19 years of age who received a video orientation and also from an App developed specifically for this study.	Total of all reporting groups
Overall Participants	71	63	66	63	263
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.03 (1.158)	16.06 (1.190)	16.08 (1.244)	15.98 (1.129)	16.04 (1.175)
Sex: Female, Male (Count of Participants)
Female	36 50.7%	36 57.1%	33 50%	40 63.5%	145 55.1%
Male	35 49.3%	27 42.9%	33 50%	23 36.5%	118 44.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Brazil	71 100%	63 100%	66 100%	63 100%	263 100%
Knowledge score (score on a scale) [Median (Full Range) ]
Median (Full Range) [score on a scale]	7.00	7.00	8.00	7.00	7.00

Outcome Measures

1. Primary Outcome

Title	Knowledge Score
Description	The knowledge score varied from 13 (five) to 0 (zero). Higher scores means better outcomes.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Orientation	Oral Orientation and App	Video Orientation	Video Orientation and App
Arm/Group Description	This group comprised 79 participants who received only oral orientation by a previously trained researcher.	This group comprised 72 participants who received orientation through oral orientation and also an App.	This group comprised 69 adolescents who received orientation through a video.	This group comprised 68 adolescents who received orientation through video and also an App.
Measure Participants	71	66	63	63
Median (Full Range) [score on a scale]	11	13	11	13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oral Orientation, Oral Orientation and App, Video Orientation, Video Orientation and App
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Adverse Event Reporting Description	The total number of "0" of participants at risk means that All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Arm/Group Title	Oral Orientation Without App		Video Without App		Oral Orientation With App		Video With App
Arm/Group Description	This group comprised of adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher.		This group comprised of adolescents from 14 to 19 years of age who received a video orientation.		This group comprised of adolescents from 14 to 19 years of age who received an oral orientation from a previously trained researcher and also from an App developed specifically for this study.		This group comprised of 68 adolescents from 14 to 19 years of age who received a video orientation and also from an App developed specifically for this study.
All Cause Mortality
	Oral Orientation Without App		Video Without App		Oral Orientation With App		Video With App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Oral Orientation Without App		Video Without App		Oral Orientation With App		Video With App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Oral Orientation Without App		Video Without App		Oral Orientation With App		Video With App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.