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NCT03216746

Oral Health Educational Methods in Adolescence

Completed NA Results posted Last updated 5 May 2020
What this trial tests

NA trial testing Oral orientation and App for smartphone in Adolescent Behavior in 288 participants. Completed in 1 December 2017.

Timeline
1 December 2016
Primary endpoint
15 November 2017
1 December 2017

Quick facts

Lead sponsorUniversidade Federal do Paraná
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment288
Start date1 December 2016
Primary completion15 November 2017
Estimated completion1 December 2017

Drugs / interventions tested

Conditions studied

Sponsor

Universidade Federal do Paraná — full company profile →

Who can join

Adults 14 to 19, any sex, with Adolescent Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Knowledge Score Primary · 30 days

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

GroupValue95% CI
Oral Orientation115 – 13
Oral Orientation and App139 – 13
Video Orientation115 – 13
Video Orientation and App1310 – 13

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Are Information Technologies Capable of Stimulating the Use of Dental Floss by Adolescents? A Cluster Randomised Clinical Trial.
    Marchetti G, Assunção LRDS, Soares GMS, Fraiz FC. · · 2020 · cited 2× · PMID 32515412 · DOI 10.3290/j.ohpd.a44684

Verify or expand the search:

Other recruiting trials for Adolescent Behavior

Currently open trials in the same condition.

Other Universidade Federal do Paraná trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03216746.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing