- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216746
Oral Health Educational Methods in Adolescence
April 24, 2020 updated by: Luciana Reichert Assunção Zanon, Universidade Federal do Paraná
Educational Methods in Oral Health for Adolescents: Influence on Knowledge and Oral Clinical Conditions
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).
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
288
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge Score
Time Frame: 30 days
|
The knowledge score varied from 13 (five) to 0 (zero).
Higher scores means better outcomes.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luciana Zanon, PhD, Universidade Federal do Parana
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
November 15, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
July 11, 2017
First Submitted That Met QC Criteria
July 12, 2017
First Posted (Actual)
July 13, 2017
Study Record Updates
Last Update Posted (Actual)
May 5, 2020
Last Update Submitted That Met QC Criteria
April 24, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 51712315.4.0000.0102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adolescent Behavior
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
-
University of CoimbraRecruitingAdolescent Behavior | Adolescent - Emotional ProblemPortugal
-
Eunice Kennedy Shriver National Institute of Child...UnknownAdolescent Behavior | Sex BehaviorUnited States
-
Rhode Island HospitalCompletedSexual Behavior | Adolescent Behavior
-
Cornell UniversityUnited States Department of Agriculture (USDA)CompletedChild Behavior | Health Behavior | Adolescent BehaviorUnited States
-
Karabuk UniversityCompleted
-
Institute of Child HealthCompletedParents | Child Behavior | Adolescent BehaviorUnited Kingdom
-
Children's Hospital Medical Center, CincinnatiTexas A&M UniversityRecruitingContraception | Health Behavior | Adolescent BehaviorUnited States
-
HopeLab FoundationStanford University; West Virginia University; Santech, IncCompletedHealth Behavior | Motivation | Adolescent BehaviorUnited States
-
Ginger YangUniversity of IowaRecruitingRisk Behavior | Adolescent Behavior | DriveUnited States
Clinical Trials on Oral orientation and App for smartphone
-
University of WashingtonCompletedDepression | AnxietyUnited States
-
Oslo Metropolitan UniversityVestre Viken Hospital Trust; Oslo University Hospital; University Hospital, Akershus and other collaboratorsCompletedGestational Diabetes MellitusNorway
-
Sir Run Run Shaw HospitalCompletedCigarette Smoking | Smartphone App-based Smoking CessationChina
-
Sun Yat-sen UniversityRecruiting
-
H. Lee Moffitt Cancer Center and Research InstituteNational Institute on Drug Abuse (NIDA)Recruiting
-
World BankDepartment for International Development, United Kingdom; Wits Reproductive... and other collaboratorsCompletedHIV Infections | Antiretroviral Therapy | Patient Compliance | Viral Load | Cell PhoneSouth Africa
-
Children's Hospital Medical Center, CincinnatiVerizon Foundation; Luther FoundationCompleted
-
University of PittsburghTerminated
-
Gazi UniversityCompleted
-
Reuth Rehabilitation HospitalActive, not recruitingChronic Pain of Left Foot (Finding) | Chronic Pain of Right Foot (Finding)Israel