NCT03216746

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 22, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

July 11, 2017

Results QC Date

July 17, 2018

Last Update Submit

April 24, 2020

Conditions

Keywords

oral healthknowledgeadolescent

Outcome Measures

Primary Outcomes (1)

  • Knowledge Score

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

    30 days

Study Arms (4)

Oral orientation and App for smartphone

EXPERIMENTAL

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

Oral orientation

EXPERIMENTAL

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

Video orientation and App for smartphone

EXPERIMENTAL

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

Video orientation

EXPERIMENTAL

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

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.

Oral orientation and App for smartphone

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.

Oral 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. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.

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.

Video orientation

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28232973BACKGROUND

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr Luciana Reichert Assunção Zanon
Organization
UFParaná

Study Officials

  • Luciana Zanon, PhD

    Universidade Federal do Paraná

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Dentistry

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 13, 2017

Study Start

December 1, 2016

Primary Completion

November 15, 2017

Study Completion

December 1, 2017

Last Updated

May 5, 2020

Results First Posted

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share