OHAC: Oral Health Among Children

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT03791632
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 4
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents.

This study could justify the implementation of public health actions in terms of prevention.

Condition or Disease	Intervention/Treatment	Phase
Schoolboy	Other: classical lecture style presentation; Other: an intervention in the form of fun workshops; Other: digital media intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Test group Classes with a classical lecture style presentation classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) classes with digital media interventionTest group Classes with a classical lecture style presentation classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop) classes with digital media intervention
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Oral Health Knowledge and Practice Among 8-9 Years Old Children.
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: witness 2 control CE2 classes without oral sensitization actions
Experimental: group intervention 1 2 CE2 classes with a classical lecture style presentation	Other: classical lecture style presentation; classical lecture style presentation
Experimental: group intervention 2 2 CE2 classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)	Other: an intervention in the form of fun workshops; an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
Experimental: group intervention 3 2 CE2 classes with digital media intervention	Other: digital media intervention; digital media intervention

Outcome Measures

Primary Outcome Measures

1. comparison of children's notes before and after a prevention intervention [1 day]

   The main result will be calculated with the total score to the questions. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25. We will compare the evolution of the averages obtained by the control group and by all three other groups with Student test

Other Outcome Measures

1. Compare the evolution of children's grades according to the type of intervention [before and after the explanation as well as one month and 6 months after the intervention]

   For the secondary objective, we will compare the evolution of the averages obtained between the three groups with intervention with ANOVA test. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25. before and after the explanation as well as one month and 6 months after the intervention

2. Determine the timeframe by which children forget the information they have been given [before and after the explanation as well as one month and 6 months after the intervention]

   A questionnaire to know the oral knowledge will be distributed to the children before and after the explanation as well as one month and 6 months after the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• All children of classrooms selectionned

Exclusion criteria:

• Children absent on the day of the intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Camille INQUIMBERT, PhD student, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03791632
• Other Study ID Numbers: RECHMPL18_0386
• First Posted: Jan 2, 2019
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 10, 2020