ClinicalTrials.gg
CompletedNCT03216746Updated May 5, 2020Results posted

Oral Health Educational Methods in Adolescence

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

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2016, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
14 Years to 19 Years
Sex
All
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Study 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).

Read the 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.

02

Conditions studied

  • Adolescent Behavior

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Keywords

  • oral health
  • knowledge
  • adolescent
03

In context

Adolescent Behavior

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.

Browse Adolescent Behavior studies →

Lead sponsor

Universidade Federal do Paraná is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents of both sexes
  • Regularly enrolled in the high school of a public institution

Exclusion criteria

Exclusion Criteria:

  • Participants with physical or mental condition
  • Absence of signing consent form
  • Adolescents with fixed orthodontic apparatus
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
288 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralOral 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.

  • BehavioralOral 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.

  • BehavioralVideo 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.

  • BehavioralVideo 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.

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What researchers measure

Primary outcomes

  1. Knowledge Score

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

    Time frame: 30 days

07

Results

Posted Apr 22, 2020

Participant flow

Participant flow — Overall Study
MilestoneOral Orientation With AppOral Orientation Without AppVideo With AppVideo Without App
Started72796869
Completed66716363
Not completed6856
Withdrew: Lost to follow-up6856

Outcome measures

PrimaryKnowledge Score

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

Time frame:
30 days
Reported as:
Median · score on a scale
Knowledge Score
score on a scaleOral OrientationOral Orientation and AppVideo OrientationVideo Orientation and App
Knowledge Score11 (5 to 13)13 (9 to 13)11 (5 to 13)13 (10 to 13)
Statistical analysis
  • Oral Orientation vs Oral Orientation and App vs Video Orientation vs Video Orientation and App · Kruskal-Wallis · p = 0.001

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Oral Orientation Without App———
Video Without App———
Oral Orientation With App———
Video With App———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oral Orientation Without AppVideo Without AppOral Orientation With AppVideo With AppTotal
Mean16.03 ± 1.15816.06 ± 1.19016.08 ± 1.24415.98 ± 1.12916.04 ± 1.175
Sex: Female, Male
Sex: Female, Male(Participants)Oral Orientation Without AppVideo Without AppOral Orientation With AppVideo With AppTotal
Female36363340145
Male35273323118
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Oral Orientation Without AppVideo Without AppOral Orientation With AppVideo With AppTotal
Count of participants————0
Region of Enrollment
Region of Enrollment(Participants)Oral Orientation Without AppVideo Without AppOral Orientation With AppVideo With AppTotal
Brazil71636663263
Knowledge score
Knowledge score(score on a scale)Oral Orientation Without AppVideo Without AppOral Orientation With AppVideo With AppTotal
Median7.00 (2 to 12)7.00 (2 to 12)8.00 (3 to 11)7.00 (1 to 12)7.00 (1 to 12)
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Vilella KD, Fraiz FC, Benelli EM, Assuncao 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. PubMed 28232973 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03216746
Lead sponsor
Universidade Federal do Paraná
Responsible party
Luciana Reichert Assunção Zanon (Pediatric Dentistry, Universidade Federal do Paraná) — Principal investigator
First posted
Jul 13, 2017
Start date
Dec 1, 2016
Primary completion
Nov 15, 2017
Completion
Dec 1, 2017
Results posted
Apr 22, 2020
Last update
May 5, 2020

Study contacts

Luciana Zanon, PhD
principal investigator · Universidade Federal do Paraná

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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