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The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children.

Primary Purpose

Dental Caries, Gingival Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Differential learning
Usual toothbrushing
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Caries, Dental, Prevention, Differential, Learning, Toothbrushing

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children aged 3 - 8 years.
  • Need for parental assistance with tooth brushing.
  • Need for check-up/ prophylaxis appointment approx. 4 and 12 weeks.

Exclusion Criteria:

  • Patients with pain/ patients with signs or symptoms to be treated.
  • Patients with systemic disease that require special attention during their dental treatment.
  • Parents / children who refuse to participate in the study.

Sites / Locations

  • Universitätmedizin GreifswaldRecruiting
  • University medicine GreifswaldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group: Usual brushing.

Test group: Differential learning group.

Arm Description

Usual motivation to brush teeth in the clinic (KAI brushing technique) in addition to brushing teeth by the parents.

Use of differential learning of tooth brushing at home, including children and parents.

Outcomes

Primary Outcome Measures

Oral hygiene - dental plaque
Plaque index (QHI: Quigley-Hein plaque index)
Oral hygiene - dental plaque
Plaque index (QHI: Quigley-Hein plaque index)
Oral hygiene - gingivitis
Gingival bleeding index (PBI: papilla bleeding index)
Oral hygiene - gingivitis
Gingival bleeding index (PBI: papilla bleeding index)

Secondary Outcome Measures

Parental acceptance
self-designed questionnaire about the acceptance (11 items), assessment using five-point Likert-scale which is from 1 (minimal value) to 5 (maximal value) e.g. with 5 strongly agree and 1 strongly disagree
Parental acceptance (mid-term)
self-designed questionnaire about the acceptance (11 items), assessment using five-point Likert-scale which is from 1 (minimal value) to 5 (maximal value) e.g. with 5 strongly agree and 1 strongly disagree

Full Information

First Posted
May 3, 2021
Last Updated
March 16, 2022
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT04905784
Brief Title
The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children.
Official Title
The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children: A Single-blind Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized clinical trial study aims to investigate the impact of home-based differential learning on tooth brushing, in particular on the reduction of plaque and maintenance of gingival health in children aged 3 to 8 years, compared to the habitual tooth brushing and instruction/demonstration tooth brushing learning method.
Detailed Description
This two-parallel arm single-blind randomized controlled clinical trial will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald. The examination of the patient will be undertaken in a dental chair set up using standard infection control guidelines for a dental examination used at the department. The allocation of the patients to the two groups will be done through asking the patients to pick up an envelope randomly from a box which contains the information and explanation for home brushing. In the first visit, the baseline dental examination and patient acceptance survey will be done to comprehensively assess each participant's oral health status, their oral hygiene status, caries experience and periodontal condition will be recorded. To assess oral hygiene status we will use plaque index (PI) (Quigley Hein, 1972) on a scale of 0 to 5. Dental caries experience will be recorded by counting the numbers of teeth that are decayed (dt/DT), missing due to caries (mt/MT), and filled (ft/FT) to generate a dmft/DMFT score. Periodontal condition will be recorded using the papillary bleeding index Index (PBI) on a scale of 0 to 4. One trained and calibrated examiner will perform the clinical examinations. The study and its objectives will be explained to the patients. For the control group, regular instructions and advice will be provided as in any regular prophylaxis session. For the test group, the exercises and movements to be performed when brushing the teeth will be explained. The patients in both groups will be also provided with explanation leaflet with the exercises and a free toothbrush. There will be no restriction on the type of the fluoridated toothpaste. The training sheet will include the following exercises: Tooth brushing while lying down. Tooth brushing with one eye covered (i.e. with the hand). Tooth brushing wearing large gloves. Tooth brushing with the non-dominant hand. Tooth brushing using both hands. Different sequence of tooth brushing compared to the practical demonstration (i.e. starting with cleaning the lingual surface instead of occlusal surface). Tooth brushing while both eyes are closed. Tooth brushing with an obstruction on the elbow of the dominant hand (i.e. wraps a piece of cloth/ scarf around the elbow). Tooth brushing while watching 3-5 minutes video (i.e. using YouTube). The parent/ child will be requested to perform each exercise one time a day for 3 days in a row before moving to the next exercise. All parent/ child will be asked to do the exercises in the same sequence. After completing the exercise for each day, children will be asked to put a sticker in the calendar table, which will be provided to them as a motivation to perform the exercises. There will be 2 follow-ups; the first follow-up after one month will include dental re-examination, using the same methods and criteria as the baseline examination as well as a questionnaire for the parents to assess their experience and acceptance of the used method. The second follow-up will be after 3 months and it will include dental re-examination, using the same methods and criteria as the baseline examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Gingival Diseases
Keywords
Caries, Dental, Prevention, Differential, Learning, Toothbrushing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, single-blind randomized controlled clinical trial.
Masking
Investigator
Masking Description
The information and instructions for the two groups will be placed in 70 envelopes, each group has 35 envelopes, and then these envelopes will be mixed randomly (as in playing cards) and at the end these envelopes will be placed in a box. Patients will be asked to randomly select an envelope from the box. The investigator assesses oral hygiene in check-up appointments without knowledge of group allocation.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group: Usual brushing.
Arm Type
Active Comparator
Arm Description
Usual motivation to brush teeth in the clinic (KAI brushing technique) in addition to brushing teeth by the parents.
Arm Title
Test group: Differential learning group.
Arm Type
Experimental
Arm Description
Use of differential learning of tooth brushing at home, including children and parents.
Intervention Type
Behavioral
Intervention Name(s)
Differential learning
Intervention Description
The patient will be requested to perform different exercises, each exercise one time a day for 3 days in a row before moving to the next exercise. All patient will be asked to do the exercises in the same sequence.
Intervention Type
Behavioral
Intervention Name(s)
Usual toothbrushing
Intervention Description
The patients in this group will be provided with the regular oral health instructions, including the traditional toothbrushing recommendations.
Primary Outcome Measure Information:
Title
Oral hygiene - dental plaque
Description
Plaque index (QHI: Quigley-Hein plaque index)
Time Frame
1 month
Title
Oral hygiene - dental plaque
Description
Plaque index (QHI: Quigley-Hein plaque index)
Time Frame
3 months
Title
Oral hygiene - gingivitis
Description
Gingival bleeding index (PBI: papilla bleeding index)
Time Frame
1 month
Title
Oral hygiene - gingivitis
Description
Gingival bleeding index (PBI: papilla bleeding index)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Parental acceptance
Description
self-designed questionnaire about the acceptance (11 items), assessment using five-point Likert-scale which is from 1 (minimal value) to 5 (maximal value) e.g. with 5 strongly agree and 1 strongly disagree
Time Frame
1 month
Title
Parental acceptance (mid-term)
Description
self-designed questionnaire about the acceptance (11 items), assessment using five-point Likert-scale which is from 1 (minimal value) to 5 (maximal value) e.g. with 5 strongly agree and 1 strongly disagree
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 3 - 8 years. Need for parental assistance with tooth brushing. Need for check-up/ prophylaxis appointment approx. 4 and 12 weeks. Exclusion Criteria: Patients with pain/ patients with signs or symptoms to be treated. Patients with systemic disease that require special attention during their dental treatment. Parents / children who refuse to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loay Leghrouz, M.Sc.
Phone
+49 3834-867136
Email
loayleghrouz@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julian schmoeckel, Dr.,M.Sc.
Phone
+49 3834-867136
Email
julian.schmoeckel@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loay Leghrouz, M.Sc.
Organizational Affiliation
Universitätmedizin Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätmedizin Greifswald
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian H Splieth, Prof. Dr.
Phone
+49 3834-867101
Email
splieth@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Julian Schmoeckel, Dr., M.Sc.
Phone
+49 3834-867136
Email
julian.schmoeckel@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Loay Leghrouz, M.Sc.
Facility Name
University medicine Greifswald
City
Greifswald
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Schmoeckel, Dr.
Phone
03834 86 7167
Email
julian.schmoeckel@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children.

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