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| Name | Class |
|---|---|
| King Abdulaziz University | OTHER |
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This study is a randomized crossover clinical trial designed to compare the effectiveness of a U-shaped automatic toothbrush (Autobrush®) versus a conventional manual toothbrush in reducing dental plaque among adolescents undergoing fixed orthodontic treatment. Each participant will be exposed to both interventions during the study period due to the crossover design.
The inclusion criteria included healthy adolescents aged 12-15 years, whom were undergoing treatment with fixed orthodontic appliances attending the Orthodontic Department at KAUD Medically compromised adolescents, those with disabilities, individuals without fixed orthodontic appliances, and adolescents with known nylon allergies were excluded.
Before appointment, participants were instructed to refrain from all oral hygiene measures (e.g., brushing, chewing gum) for 12 hours. On the appointment time, at the clinic, participants are assigned randomly to a toothbrush group and given disclosing solution to visualize plaque.
The FMPS was recorded before brushing. Then, participants brush under supervision with their assigned toothbrush group, either manual toothbrush using Bass technique for 2 minutes or using Autobrush® with side-to-side motion for 30 seconds. After brushing, FMPS is reassessed using the same disclosing procedure. Following a washout period of at least 2 weeks, the participant repeats the procedure with the alternative toothbrush.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | This is a randomized crossover clinical trial design. Participants were randomly assigned to use the Autobrush® during the first phase. After a washout period, the groups switched to a manual toothbrush. |
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| Group 2 | Experimental | This is a randomized crossover clinical trial design. Participants were randomly assigned to use a manual toothbrush during the first phase. After a washout period, the groups switched to Autobrush® . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U-shaped toothbrush (Autobrush®) | Device | U-shaped toothbrush (Autobrush®) was used |
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| Measure | Description | Time Frame |
|---|---|---|
| The main outcome variable is the Full Mouth Plaque Score (FMPS) | Plaque levels were recorded on six sites per tooth (three buccal and three lingual), both before and after brushing. The FMPS difference is calculated as: FMPS difference = FMPS before brushing - FMPS after brushing This difference is expressed as a percentage: (Number of sites with plaque / Total number of sites examined) × 100 | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz University - Faculty of Dentistry | Jeddah | Saudi Arabia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2024 | Apr 12, 2026 | Prot_SAP_000.pdf |
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| Manual regular toothbrush | Device | Manual regular toothbrush |
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