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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: Usual brushing. | Active Comparator | Usual motivation to brush teeth in the clinic (KAI brushing technique) in addition to brushing teeth by the parents. |
|
| Test group: Differential learning group. | Experimental | Use of differential learning of tooth brushing at home, including children and parents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Differential learning | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral hygiene - dental plaque | Plaque index (QHI: Quigley-Hein plaque index) | 1 month |
| Oral hygiene - dental plaque | Plaque index (QHI: Quigley-Hein plaque index) | 3 months |
| Oral hygiene - gingivitis | Gingival bleeding index (PBI: papilla bleeding index) | 1 month |
| Oral hygiene - gingivitis | Gingival bleeding index (PBI: papilla bleeding index) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Parental acceptance (mid-term) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loay Leghrouz, M.Sc. | Contact | +49 3834-867136 | loayleghrouz@hotmail.com | |
| Julian schmoeckel, Dr.,M.Sc. | Contact | +49 3834-867136 | julian.schmoeckel@uni-greifswald.de |
| Name | Affiliation | Role |
|---|---|---|
| Loay Leghrouz, M.Sc. | Universitätmedizin Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätmedizin Greifswald | Recruiting | Greifswald | Mecklenburg-Vorpommern | 17489 | Germany |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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Parallel group, single-blind randomized controlled clinical trial.
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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.
| Usual toothbrushing | Behavioral | The patients in this group will be provided with the regular oral health instructions, including the traditional toothbrushing recommendations. |
|
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 |
| 3 months |
| University medicine Greifswald | Recruiting | Greifswald | Germany |
|
| D009059 |
| Mouth Diseases |