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The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.
Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile phone application | Experimental | Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day. |
|
| Verbal oral hygiene instructions | Active Comparator | Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile phone application | Behavioral |
| ||
| Verbal oral hygiene instructions |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque Index | Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque. | At baseline and after 4 weeks. |
| Change in Gingival Index | Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding. | At baseline and after 4 weeks. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar H AlKadhi, BDS, MS | Riyadh Colleges of Dentistry and Pharmacy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28705122 | Derived | Alkadhi OH, Zahid MN, Almanea RS, Althaqeb HK, Alharbi TH, Ajwa NM. The effect of using mobile applications for improving oral hygiene in patients with orthodontic fixed appliances: a randomised controlled trial. J Orthod. 2017 Sep;44(3):157-163. doi: 10.1080/14653125.2017.1346746. Epub 2017 Jul 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Phone Application | Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day. Mobile phone application |
| FG001 | Verbal Oral Hygiene Instructions | Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks. Verbal oral hygiene instructions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Phone Application | Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day. Mobile phone application |
| BG001 | Verbal Oral Hygiene Instructions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plaque Index | Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque. | Posted | Mean | Standard Deviation | units on a scale | At baseline and after 4 weeks. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Phone Application | Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day. Mobile phone application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Omar Alkadhi | Riyadh Colleges of Dentistry and Pharmacy | 966505154754 | omar.alkadhi@riyadh.edu.sa |
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| Behavioral |
|
Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Verbal oral hygiene instructions
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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|
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| Primary | Change in Gingival Index | Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding. | Posted | Mean | Standard Deviation | units on a scale | At baseline and after 4 weeks. |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Verbal Oral Hygiene Instructions | Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks. Verbal oral hygiene instructions | 0 | 22 | 0 | 22 | 0 | 22 |
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| Wilcoxon (Mann-Whitney) | 0.0002 | Mean Difference (Net) | -0.1177 | 2-Sided | Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline. The mean difference was calculated as follows: gingival index at 4 weeks - gingival index at baseline | Superiority |
| Wilcoxon (Mann-Whitney) | 0.4809 | Mean Difference (Net) | 0.1014 | 2-Sided | Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline. The mean difference was calculated as follows: gingival index at 4 weeks - gingival index at baseline | Superiority |