An interventional study of Oral orientation and App for smartphone and Oral orientation in Adolescent Behavior, sponsored by Universidade Federal do Paraná. Completed. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Universidade Federal do Paraná · Not applicable, Interventional, and Prevention
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).
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.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's enrollment of 288 is above the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
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Exclusion Criteria:
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
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
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
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
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.
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.
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.
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.
Knowledge Score
The knowledge score varied from 13 (five) to 0 (zero). Higher scores means better outcomes.
Time frame: 30 days
| Milestone | Oral Orientation With App | Oral Orientation Without App | Video With App | Video Without App |
|---|---|---|---|---|
| Started | 72 | 79 | 68 | 69 |
| Completed | 66 | 71 | 63 | 63 |
| Not completed | 6 | 8 | 5 | 6 |
| Withdrew: Lost to follow-up | 6 | 8 | 5 | 6 |
The knowledge score varied from 13 (five) to 0 (zero). Higher scores means better outcomes.
| score on a scale | Oral Orientation | Oral Orientation and App | Video Orientation | Video Orientation and App |
|---|---|---|---|---|
| Knowledge Score | 11 (5 to 13) | 13 (9 to 13) | 11 (5 to 13) | 13 (10 to 13) |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Orientation Without App | — | — | — |
| Video Without App | — | — | — |
| Oral Orientation With App | — | — | — |
| Video With App | — | — | — |
| Age, Continuous(years) | Oral Orientation Without App | Video Without App | Oral Orientation With App | Video With App | Total |
|---|---|---|---|---|---|
| Mean | 16.03 ± 1.158 | 16.06 ± 1.190 | 16.08 ± 1.244 | 15.98 ± 1.129 | 16.04 ± 1.175 |
| Sex: Female, Male(Participants) | Oral Orientation Without App | Video Without App | Oral Orientation With App | Video With App | Total |
|---|---|---|---|---|---|
| Female | 36 | 36 | 33 | 40 | 145 |
| Male | 35 | 27 | 33 | 23 | 118 |
| Race and Ethnicity Not Collected(Participants) | Oral Orientation Without App | Video Without App | Oral Orientation With App | Video With App | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Oral Orientation Without App | Video Without App | Oral Orientation With App | Video With App | Total |
|---|---|---|---|---|---|
| Brazil | 71 | 63 | 66 | 63 | 263 |
| Knowledge score(score on a scale) | Oral Orientation Without App | Video Without App | Oral Orientation With App | Video With App | Total |
|---|---|---|---|---|---|
| Median | 7.00 (2 to 12) | 7.00 (2 to 12) | 8.00 (3 to 11) | 7.00 (1 to 12) | 7.00 (1 to 12) |
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Universidade Federal do Paraná